[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"migraine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:migraine":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,141,0,25,[9,52,76,103,134,166,189,220,256,283,315,342,367,394,410,436,461,495,521,539,565,592,616,644,665],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100652814","high--vs-standard-dose-intravenous-magnesium-for-acute-headache-100652814",false,"NCT07779486","High- vs Standard-Dose Intravenous Magnesium for Acute Headache","Intravenous Magnesium Sulfate Versus Paracetamol for the Treatment of Acute Non-Traumatic Headache in the Emergency Department: A Randomized Double-Blind Controlled Trial","MAGHEAD","Inclusion Criteria:\n\n* Age ≥18 years\n* Presentation to the emergency department with acute non-traumatic headache of less than 72 hours duration\n* Diagnosis consistent with a primary headache disorder, including:\n\n  * Migraine\n  * Tension-type headache\n  * Cluster headache (according to ICHD-3 criteria)\n* Moderate to severe pain intensity (VAS ≥5\u002F10)\n* Ability to understand the study procedures and provide informed consent\n\nExclusion Criteria:\n\n* Suspected or confirmed secondary headache (e.g., intracranial hemorrhage, infection, mass lesion)\n* Recent head trauma\n* Known hypersensitivity or contraindication to magnesium sulfate or paracetamol\n* Use of analgesic medication within the previous 6 hours\n* Pregnancy or breastfeeding\n* Severe renal insufficiency or conditions contraindicating magnesium administration\n* Hemodynamic instability or clinically significant cardiac conduction disorders Prior participation in this study","ALL","18 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"NA","Headache is one of the most common reasons for consultation in emergency departments and represents a significant cause of disability, particularly in patients with migraine and other primary headache disorders. Despite the availability of several analgesic treatments, including nonsteroidal anti-inflammatory drugs and paracetamol, pain relief is often incomplete, and a proportion of patients require additional rescue therapy.\n\nMagnesium sulfate has emerged as a potential therapeutic option in acute headache due to its role in modulating neuronal excitability, vascular tone, and pain-related neurotransmitter release. However, its efficacy as a standalone treatment, the optimal intravenous dose, and its comparative effectiveness versus standard therapy remain unclear.\n\nThis randomized, double-blind, controlled trial aims to evaluate the efficacy and safety of intravenous magnesium sulfate in the treatment of acute non-traumatic headache in the emergency department. Participants will be randomly assigned to receive either low-dose magnesium sulfate (2 g IV), high-dose magnesium sulfate (4 g IV), or intravenous paracetamol (1 g IV) as an active comparator.\n\nThe primary outcome is the change in pain intensity measured using the Visual Analog Scale (VAS) at 60 minutes after treatment administration, as well as the proportion of patients achieving at least 50% pain reduction. Secondary outcomes include time course of pain relief, need for rescue medication, adverse events, patient satisfaction, and length of stay in the emergency department.\n\nIn addition, the study will assess baseline ionized magnesium levels to explore their relationship with treatment response and evaluate whether magnesium levels may predict clinical efficacy.\n\nThe results of this study may help clarify the role of intravenous magnesium sulfate in the management of acute headache and potentially improve treatment strategies in emergency settings.",[28,29,30,31],"Acute Headache","Migraine","Tension-type Headache","Cluster Headache",[33,29,34,35,36,37,38],"Acute headache","Emergency department","Intravenous magnesium Magnesium sulfate","Paracetamol","Acute pain","Analgesia","RECRUITING","2026-08-19",{"date":42,"type":43},"2026-08-21","ACTUAL",{"date":45,"type":43},"2026-06-01",{"date":47,"type":22},"2030-12-31",{"name":49,"class":50},"University of Monastir","OTHER",1,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100642179","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-elismetrep-k-304-in-the-acute-treatment-of-migraine-100642179","NCT07645924","A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Acute Treatment of Migraine","Inclusion Criteria:\n\n1\\. Be a male or female, age 18 to 75 years, inclusive, at the time of signing informed consent. 2. Has greater than a one-year history of migraine with or without aura as defined by International Headache Society criteria 1.1 and 1.2 and his\u002Fher migraines typically last between 4 to 72 hours, if untreated. 3. Has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the 2 months prior to screening (Visit 1). 4. Meet the following requirements:\n\na. Is a male OR b. Is a female who is of non-childbearing potential defined by at least one of the following criteria: i. Postmenopausal as defined by one of the following:\n\n1. A minimum of 12 months of spontaneous amenorrhea or\n2. A minimum of 6 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone level \\> 40 mIU\u002FmL or\n3. At least 6 weeks post bilateral oophorectomy (with or without hysterectomy). OR ii. Post hysterectomy or bilateral salpingectomy, based on the participant's recall of their medical history OR c. Is a female of reproductive potential and: i. Agrees to remain abstinent from heterosexual activity OR ii. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the End of Study visit.\n\nAcceptable methods of birth control are:\n\n1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal).\n2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable).\n3. Intrauterine device (IUD);\n4. Intrauterine hormone-releasing system (IUS);\n5. Bilateral tubal occlusion;\n6. Vasectomized partner;\n7. Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action;\n8. Male or female condom with or without spermicide;\n9. Cap, diaphragm or sponge with spermicide; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods).\n\n5\\. Voluntarily agrees to participate in the study by giving written informed consent. 6. Is able to read, understand and complete the study questionnaires and eDiary. 7. Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions. 8. Be willing to use their own personal, qualified smartphone to download study specific eDiary applications for use during the study.\n\nExclusion Criteria:\n\nParticipants are excluded from the trial if any of the following criteria apply:\n\n1. Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the trial.\n\n   Migraine history-related\n2. Has difficulty distinguishing his\u002Fher migraine attacks from tension-type headaches.\n3. Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours.\n4. Has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening (Visit 1).\n5. Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine.\n6. Was \\>50 years old at age of first migraine onset.\n7. Is taking migraine prophylactic medication where the prescribed dose has changed during the 3 months prior to screening (Visit 1) or anticipates any change during the study. Any withdrawal of preventive medications for the treatment of migraine should be completed at least 30 days prior to screening.\n\n   Medical history related\n8. Has, in the opinion of the investigator, other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression, history of psychosis, dementia, or significant neurological disorders other than migraine \\[Patients who are currently being treated with non-prohibited medication for depression and symptoms are well controlled, in the opinion of the investigator, are eligible to participate in this study\\].\n9. Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Patients must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in the past 2 months or suicidal behavior in the past 6 months.\n10. Has a recent history (within the past 3 years of the screening visit) or current diagnosis or evidence of endocrine, hematological, immunological (including Sjogren's syndrome), renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases or hepatic impairment that, per the investigator's judgement, may jeopardize the subject's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and\u002For safety results.\n11. Has a history of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed if they have received treatment and follow-up consistent with local standard of care.\n12. Has a history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening.\n13. Has a history of human immunodeficiency virus disease.\n14. Has a history of gastric or small intestinal surgery (including gastric bypass surgery or banding but not including cholecystectomy or appendectomy) or has a disease that causes malabsorption or may otherwise alter the absorption of orally administered drugs (e.g. upper gastrointestinal dysmotility).\n\n    Laboratory, vital sign, and electrocardiogram related\n15. Has a positive test result at screening for hepatitis B surface antigen, hepatitis C virus antibody.\n16. Has a screening estimated glomerular filtration rate estimated with the Modification of Diet in Renal Disease (MDRD) equation of \\\u003C30 mL\u002Fmin\u002F1.73 m2.\n17. Has a screening result for alanine aminotransferase or aspartate aminotransferase of \\>2.0 X upper limit of normal (ULN) or total bilirubin \\>1.5 X ULN at the Screening visit. Note: An isolated bilirubin \\>1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin is within the laboratory normal range.\n18. Has a mean value for triplicate corrected QT interval to Fridericia's formula (QTcF) \\>450 ms for males and \\>470 ms for females at screening.\n19. Has a mean value for triplicate seated systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>95 mmHg measured after at least 5 minutes at rest at the Screening Visit. Note: If a participant's blood pressure is exclusionary on the first triplicate assessment at the Screening Visit, they may have one repeat triplicate blood pressure assessment at that visit after another rest of at least 10 minutes.\n\n    Medication use and substance abuse related\n20. Has known history of or suspected abuse of alcohol or recreational drugs at Screening.\n21. Has use of soft drugs (such as marijuana or any substances containing tetrahydrocannabinol \\[THC\\] or cannabidiol \\[CBD\\] within 3 months prior to screening, or hard drugs (such as cocaine, illicit narcotics\u002Fopiates) within 6 months prior to screening.\n22. Has a positive drug screen at screening. Note:\n\n    1. If benzodiazepines are detected on the drug screen, this is not exclusionary if they are prescribed a benzodiazepine for a therapeutic purpose (e.g., for insomnia) and confirmatory documentation is obtained from the prescribing physician.\n    2. If amphetamines are detected on the drug screen, this is not exclusionary if the participant is taking a stimulant medication for a therapeutic purpose (e.g., Adderall for attention deficit hyperactivity disorder), confirmatory documentation is obtained from the prescribing physician, and the stimulant medication in question is known to be detected as amphetamine on the drug screen being used.\n23. Is currently in violation of study requirements for prohibited and permissible concomitant medications or treatments (not already specified in other criteria) or is anticipated to violate these requirements during study participation (detailed in the protocol). Note: Any use of the following within 8 weeks of the screening visit, or anticipated use at any point during study participation are exclusionary:\n\n    1. Devices for the acute and\u002For preventative treatment of headache (migraine and\u002For other type of headache)\n    2. Nerve blocks and\u002For trigger point injections for the acute and\u002For preventative treatment of headache (migraine and\u002For other type of headache).\n24. Has any use of prescription opiate medications within 14 days of screening or any anticipated\u002Fpotential use of opiates during study participation.\n25. Has a history of use of ergotamine medications ≥10 days per month on a regular basis for ≥3 months prior to screening.\n26. Has a history of non-narcotic analgesic intake ≥15 days per month for ≥3 months prior to screening.\n\n    Other\n27. Has known or suspected hypersensitivity to trial product(s) or related products.\n28. Has a history of multiple significant and\u002For any severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.\n29. Has any surgery scheduled for the duration of the trial.\n30. Has a screening hemoglobin \\\u003C11.0 g\u002FdL (males) or \\\u003C10.0 g\u002FdL (females) or has a known hemoglobinopathy (e.g., sickle cell anemia, hemolytic anemia).\n31. Has previous participation in this trial. Participation is defined as signed informed consent.\n32. Has participated in any clinical trial of an approved or non-approved investigational biological medicinal product (e.g., antibody therapy) within 90 days of screening or has participated in any clinical trial of an approved or non-approved investigational small molecule medicinal product within 30 days or 5 half-lives (whichever is longer) of screening or ever signed an informed consent for Study K-304 P004. Note: Patients may not be screened at more than one trial site for this study.\n33. Has any other disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and\u002For safety results.\n34. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.","75 Years",{"count":61,"type":22},1800,[63],"PHASE3","This is a double-blind, randomized, multicenter, outpatient evaluation of the efficacy, safety, and tolerability of elismetrep, as compared with placebo, in the acute treatment of migraine.",[29],{"date":67,"type":43},"2026-08-20",{"date":69,"type":43},"2026-07-01",{"date":71,"type":22},"2027-02",{"name":73,"class":74},"Kallyope Inc.","INDUSTRY",113,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100448887","phase-3-study-to-assess-adverse-events-and-disease-activity-of-oral-ubrogepant-tablets-for-the-acute-treatment-of-migraine-in-children-and-adolescents-ages-6-17-100448887","NCT05125302","Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)","Ubro Peds","Inclusion Criteria:\n\n* A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD-3) for at least 6 months.\n* By history, the participant's migraines typically last between 3 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom.\n* History of 1 to 14 migraine attacks per month with moderate to severe headache in each of the 2 months prior to screening (Visit 1).\n* Current or past use of at least 1 oral medication (over-the-counter medication or prescription medication) for the acute treatment of migraine.\n* For main study participants, treatment of a qualifying migraine with single-blind placebo during the screening period and completion of 2-hour headache pain assessment.\n* Weight is ≥ 20 kg (44 pounds) and \\\u003C 135 kg (298 pounds)\n* Per investigator judgment, participant is able to swallow or can learn to swallow study intervention.\n* The participant is able to understand and complete the study questionnaires and eDiary. Participants who need assistance with reading the assessments may be assisted by a parent or guardian.\n\nExclusion Criteria:\n\n* Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.\n* In the opinion of the investigator, other confounding pain syndromes, confounding psychiatric conditions, or other significant neurological disorders other than migraine.\n* History of malignancy in the 5 years prior to Visit 1.\n* History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of the study intervention.\n* Significant risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others; participants must be excluded if they report suicidal ideation with intent, with or without a plan, (ie, Type 4 or 5 on the C-SSRS) in the past 6 months or report suicidal behavior in the last 6 months prior to Visit 1 or Visit 2 assessments.\n* At Visit 1, current alcohol or drug abuse or dependence per investigator's judgment.\n* For main study participants, no headache at the 2-hour post dose assessment after taking single-blind placebo for a qualifying migraine during screening period (ie, placebo responder).\n* A current diagnosis of chronic migraine as defined by ICHD-3\n* Participants who overuse medication for migraine defined as use of opioids or barbiturates \\> 2 days\u002Fmonth, triptans or ergots ≥ 10 days\u002Fmonth, simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 15 days\u002Fmonth or any combination of triptans, ergots, or simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 10 days\u002Fmonth in the 3 months prior to Visit 1 per investigator's judgment.\n* Difficulty distinguishing migraine headache from tension-type or other headaches.\n* Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3.\n* Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3\n* Required in-hospital (excluding emergency department visits) treatment for migraines 3 or more times in the 6 months prior to Visit 1.\n* Requirement for any medication (eg, barbiturates) or diet (eg, grapefruit juice) that is on the list of prohibited concomitant medications that cannot be discontinued or switched to an allowable, alternative medication at Visit 1.\n* Previous exposure, within the last 6 months, to injectable monoclonal antibodies blocking the calcitonin gene-related peptide (CGRP) pathway\n* History of hypersensitivity or clinically significant adverse reaction to a CGRP receptor antagonist or hypersensitivity to any component of the study interventions, ubrogepant or placebo.\n* Currently participating or has participated in a study with an investigational compound or device within 30 days prior to Visit 1","6 Years","17 Years",{"count":87,"type":22},1059,[63],"Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents.\n\nUbrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants - PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment.\n\nFor qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention. There will be an option to take a second dose of double-blind study intervention (identical to initial dose), or rescue medication, at least 2 hours after the initial dose, for headache of moderate\u002Fsevere intensity. Around 1059 participants will be enrolled in the study in approximately 120 sites in the United States. The study duration will be up to 6 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[29],[29,92,93,94],"Ubrogepant","Ubrelvy","PERISCOPE",{"date":42,"type":43},{"date":97,"type":43},"2022-01-13",{"date":99,"type":22},"2027-05",{"name":101,"class":74},"AbbVie",125,{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":110,"maxAge":19,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":51},"100652300","neuromodulation-during-the-prodrome-to-prevent-disabling-migraine-attacks-in-youth-100652300","NCT07772427","Neuromodulation During the Prodrome to Prevent Disabling Migraine Attacks in Youth","Neuromodulation During the Prodrome to Prevent Disabling Migraine Attacks in Children and Adolescents - a Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* youth aged 8-\\\u003C18 years with a diagnosis of migraine using gold standard International Classification of Headache Disorders criteria\n* self-reporting 2-14 headache days\u002Fmonth in the last 3 months\n* reporting prodromal symptoms that predict a headache within six hours \\>75% of the time.\n\nTo proceed past the 60-day screening period to randomization, participants will need to report 3-28 qualifying prodrome events with \\>75% of these events followed by a headache within 6 hours.\n\nExclusion Criteria:\n\n* the inability to read or understand English\n* a diagnosis of psychosis, schizophrenia, or moderate-severe autism, moderate-severe developmental delay or moderate-severe intellectual disability\n* implanted electrical device\n* uncontrolled epilepsy (i.e., \\>2 seizures in the past year)\n* abnormal skin on both upper arms\n* arm circumference \\\u003C20 cm\n* severe cardiac or cerebrovascular disease\n* prior participation in the trial","8 Years",{"count":112,"type":22},30,[25],"Background \\& Rationale:\n\nOne in ten Canadian youth have migraine, a disabling neurological disease that is more common in females and characterized by moderate-severe disabling headaches. Migraine attacks occur in a cycle that begins with a prodromal phase, followed by aura, a pain phase (headache), and finally a postdrome phase when the pain is resolved but other symptoms persist. The prodrome is recognized by \\~90% of all youth with migraine, occurs up to 24 hours before headache onset, and consists of a variety of symptoms including, but not limited to, food cravings, fatigue, yawning, mood changes, and sensory hypersensitivity (e.g., light sensitivity). Prodromal symptoms are disabling and frequently graded as moderate to severe. All acute migraine treatments for youth have been studied for use in the pain phase, with the greatest treatment success early in this phase. Unfortunately, only \\~1\u002F3 of youth achieve pain freedom within two hours. Recently, a groundbreaking trial found that treatment during the prodrome could prevent the pain phase, although prodromal treatment does not exist for youth.\n\nIn considering the most innovative, safe, and patient-centered prodromal intervention, remote electrical neuromodulation (REN) is the obvious choice. The investigator's engagement with 175 youth with migraine and their caregivers shows that REN is preferred when pill-based interventions are ineffective or impractical. REN has none of the limitations of pill-based prodromal treatment. The REN device is wearable, battery-operated, worn on the upper arm, and controlled wirelessly by a smartphone application. REN electrically stimulates sensory nerves in the arm below their perceived pain thresholds, but above their depolarization thresholds, to induce a conditioned pain modulation response in the brain to modulate incoming migraine pain signals.\n\nClinical trial and observational studies in youth with migraine have shown REN's safety and efficacy for home-based treatment during the pain phase and led the FDA to clear its use in youth \\>8 years. In the adolescent trial, 71% of participants had pain relief at two hours, there were no serious adverse events (AE), and only one device-related AE (transient arm pain) occurred. Also, emerging data show that adults with migraine in the prodrome phase display pain facilitation due to a deficit in pain modulation. Thus, REN's mechanism of action is likely to be more effective during the prodrome vs. the pain phase as it can \"turn on\" deficient pain modulatory areas earlier when they are most impaired.\n\nResearch Question \\& Objectives:\n\nThe investigators aim to determine the feasibility of implementing REN treatment during the prodrome to prevent migraine pain in youth with migraine, and hypothesize that:\n\n1. trial design will be feasible\n2. REN will be feasible for prodromal treatment, with \\>80% of participants using their assigned device to treat a qualifying prodrome.\n\nThe following feasibility and acceptability outcomes will be measured:\n\n1. proportion of eligible youth that are enrolled into the screening period, subsequently randomized, and treat a qualifying prodrome with REN.\n2. recruitment rate, retention, and withdrawals.\n3. participant feedback.\n\nAll secondary outcomes will be reported descriptively, and adverse events will be recorded and reported.\n\nMethods:\n\nThis study will be a pilot randomized, single centre, double-blind, parallel group, sham-controlled trial comparing active to sham REN for the prevention of headache within 24 hours of treating prodromal symptoms in youth with migraine. Participants will be recruited from headache and neurology clinics at the Alberta Children's Hospital.\n\nEligible and consenting participants will complete an intake visit and enter a 60-day screening period where they will complete electronic daily diaries to determine prodrome or headache occurrence and features. Participants with 3-28 qualifying prodromes during screening, where \\>75% are followed by a headache within 6 hours, will be randomized 1:1 to treat one qualifying prodrome with active or sham REN over a 60-day treatment period. Participants will be trained on device use and will be instructed to not use any co-interventions during the qualifying prodrome; if headache onsets after the prodrome, participants will be instructed to use their typical acute treatment. During the treated prodrome, a survey will determine the presence, type, and number of prodromal symptoms. Surveys at 2, 24, and 48 hours post-treatment will record the presence or absence of headache, its characteristics, and AEs.\n\nThe randomization sequence will be prepared by a biostatistician and will follow randomly ordered blocks of four and six, with variable block sizes. Only research pharmacists will have access to this sequence to prepare consecutively numbered blinded and matched study kits. These kits will contain a restricted mobile phone with only the REN software application pre-installed.",[29,116],"Migraine Headache",[118,119,120,121,122,123,124],"pediatric","migraine","headache","neuromodulation","prodrome","treatment","REN","NOT_YET_RECRUITING","2026-08-15",{"date":40,"type":43},{"date":129,"type":22},"2026-10",{"date":131,"type":22},"2028-09",{"name":133,"class":50},"University of Calgary",{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":140,"sex":18,"minAge":110,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":51},"100490713","nimh-rhythms-and-blues-study-a-prospective-natural-history-study-of-motor-activity-mood-states-and-bipolar-disorder-100490713","NCT05669703","NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Aged 8 and older\n3. Probands must have at least one first-degree relative agree to participate\n4. Affected probands must have a lifetime history of a mood disorder\n5. Unaffected probands must have no lifetime history of a mood disorder\n6. In good general health as evidenced by medical history\n7. Agreement to adhere to Lifestyle Considerations throughout study duration\n8. Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nThe presence of certain medical conditions may interfere with the interpretation or increase risk of medical complications of the assessments including exercise. Therefore, an individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Pregnancy\n2. People in acute episodes of mania or depression (not excluded, but will delay study entry until sufficiently managed to allow participation in study procedures).",true,"70 Years",{"count":143,"type":22},1260,"OBSERVATIONAL","Background:\n\nMood disorders, such as bipolar disorder, can have serious effects on a person s life. People with bipolar disorder are more likely to have heart disease and abuse substances. In this natural history study, researchers would like to learn more about the connection between exercise and mental health in people with and without mood disorders.\n\nObjective:\n\nTo better understand relationships among physical activity, sleep, and mental health.\n\nEligibility:\n\nPeople aged 8 to 60 years with a history of a mood disorder. Healthy spouses and relatives with no mood disorders are also needed.\n\nDesign:\n\nParticipants will be in the study up to 2 years.\n\nFor up to 20 days in a row, at 4 times during the study, participants will:\n\nComplete an electronic diary on their smartphone. Participants will answer questions about their mood, health, sleep, and daily activities.\n\nWear an activity monitor, like a wristwatch, that records how much they move.\n\nWear a light sensor, as a necklace, to record the amount of light in their environment.\n\nSome participants will do additional tests. Twice during the study, for 3 days in a row, they will:\n\nWear monitors to record their temperature, heart rate, and sleep.\n\nProvide saliva samples.\n\nComplete cognitive tasks on their smartphone.\n\nParticipants will visit the NIH clinic 2 times. They will have a physical exam, with blood and urine tests. They will wear a heart monitor. They will ride a stationary bike for 30 minutes. They may have an imaging scan.\n\nSome participants will stay overnight. They will go to sleep wearing a cap to measure their brain activity.",[147,148,29],"Bipolar Disorder","Major Depression",[150,151,152,153,154,155],"Mood Disorders","Actigraphy","CIRCADIAN RHYTHMS","Sleep","Ecological Momentary Assessments","Natural History","2026-08-12",{"date":158,"type":43},"2026-08-13",{"date":160,"type":43},"2023-11-03",{"date":162,"type":22},"2027-07-31",{"name":164,"class":165},"National Institute of Mental Health (NIMH)","NIH",{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":175,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":187,"locationsCount":51},"100651799","phase-2-visual-instillation-of-sphenopalatine-block-intervention-for-ongoing-migraine-100651799","NCT07764783","Visual Instillation of Sphenopalatine-block Intervention for ONgoing Migraine","VISION","Inclusion criteria:\n\n* Aged 18 years or older\n* Any race\n* Any gender\n* At least 2 of 3 positives (a, b, c) below on the ID Migraine Screener from the American Headache Society:\n\n  1. Photophobia\n  2. Inability to function\n  3. Nausea\n* At least 3 months of patient-reported episodic or persistent discomfort, pain, or pressure in the anatomic distribution of the paranasal sinuses, orbits, or nasal cavities.\n* The patient experiences at least 10 days of headaches and\u002For FPP within a 30-day period, during the run-in phase.\n* No evidence of abnormal sinus findings on imaging \\[paranasal sinus CT, including cone beam imaging, or MRI (MRI images must include all paranasal sinuses) obtained when symptomatic in the last 12 months prior to presentation. Normal imaging findings included isolated mucus retention cysts 2 cm or less in size and minimal non-circumferential (isolated areas) mucosal thickening (3mm or less).\n* Normal endoscopy if performed prior to enrollment, defined as the absence of purulent (opaque - white or other discolored - secretions) at the middle meatus or sphenoethmoid recess or nasal polyp disease.\n* Daily access to a cell phone that can function with the study mobile application\n* For women of child bearing potential: not pregnant and using a method of contraception during the duration of the study.\n* The patient can be taking interventional and preventive medications and other treatments before and during the study period, including new medications which will be tracked. The clinical coordinator will ask the patient to refrain from taking any abortive medication, cannabis, and psilocybin 24 hours prior to the procedure visit.\n\nExclusion criteria:\n\n* Prior endoscopic sinus surgery within the 3 months prior to enrollment.\n* Nasal endoscopy if performed prior to enrollment shows severe signs of mucosal infection, (mucopurulent drainage) or nasal polyposis.\n* A history of anterior skull base neoplasia.\n* Nasal endoscopy if performed prior to enrollment does not allow visualization of the middle turbinate on endoscopy bilaterally after application of a topical decongestant.\n* Signs of active or chronic sinusitis on CT (\\>3mm mucosal thickening or air fluid level in any paranasal sinus.)\n* The patient cannot tolerate the use of topical anesthetics or intranasal endoscopy without sedation or general anesthesia\n* Unable to see the middle meatus with either a nasal speculum or an endoscope\n* Allergy to lidocaine or other local anesthetics (tertiary amine class 1b).\n* Is currently using a schedule II narcotic for migraine pain.\n* Current cocaine use or cocaine use within the last 30 days.\n* Currently immunocompromised\n* History or evidence of any other unstable or clinically significant medical condition that in the opinion of the sponsor-investigator\u002F Principal Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n* Has received any investigational agent within 30 days of enrollment.\n* Plans to participate in a concurrent clinical trial.",{"count":174,"type":22},74,[176],"PHASE2","The goal of this double-blinded, randomized placebo controlled clinical trial is to to see if using a numbing medicine (lidocaine) on certain areas inside the nose can help with headaches, neck pain, facial pain and pressure, and other symptoms. It also aims to understand the pathophysiology that causes these symptoms.\n\nThe main questions it aims to answer are:\n\n1. Is applying numbing medication directly to the sphenopalatine ganglion (SPG) area, while watching through the scope to make sure it's in the right place, a workable and effective way to treat migraine headaches immediately and 24 hours?\n2. Is applying numbing medication directly to the sphenopalatine ganglion (SPG) area, while watching through the scope to make sure it's in the right place, a workable and effective way to improve patient-reported outcomes?\n\nThe 2-month study requires:\n\n* One virtual visit (on the computer)\n* One visit to the office for placement of the numbing medicine under direct vision\n* Daily headache diary entries that take less than two minutes to complete",[29,179,180],"Facial Pain or Pressure","Headache","2026-08-10",{"date":183,"type":43},"2026-08-14",{"date":185,"type":22},"2026-09",{"date":131,"type":22},{"name":188,"class":50},"Association of Migraine Disorders",{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":196,"minAge":19,"maxAge":197,"enrollmentInfo":198,"targetDuration":199,"studyType":144,"phases":4,"briefSummary":200,"conditions":201,"keywords":202,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":51},"100522632","emgality-for-migraine-in-breastmilk-100522632","NCT06085144","Emgality for Migraine in Breastmilk","Prospective Evaluation of Emgality (Galcanezumab) in Breastmilk in Adult Women With Migraine","Inclusion Criteria:\n\n* Female\n* Childbearing age (18-45)\n* Established diagnosis of migraine\n* Status post uncomplicated delivery (no long-term maternal complications)\n* No prolonged (\\>3 night) NICU stay for infant\n* Between 14 days and 9 months postpartum, and still nursing, at the time of enrollment\n* Planning to receive galcanezumab postpartum\n* Suitable candidate to receive galcanezumab postpartum, at discretion of prescribing clinician\n\nExclusion Criteria:\n\n* Contraindications to breastfeeding, such as prior surgery or infant contraindications\n* Contraindications to galcanezumab or insurance coverage\n* Use of gepants\n* Moderately Severe or Severe Depression as established by the PHQ9 screen (i.e. score 15 or above)\n* Pregnant or planning pregnancy in the coming 6M\n* Patients with severe mastitis will not be enrolled; should mastitis occur during the study, this will be included as a covariate and results analyzed accordingly\n* Patients of infants with severe medical issues identified in the health record (developmental issues, delivery issues, concomitant medications)","FEMALE","45 Years",{"count":112,"type":22},"1 Year","The goal of this project is to evaluate galcanezumab transfer into maternal breastmilk, and to evaluate infant (growth, development, constipation, colic, infections) and maternal (headache) outcomes for dyads in which the mother was treated with galcanezumab and to compare outcomes for infants who were or were not breastfed after maternal treatment.\n\nIn this prospective observational study, the study team proposes to prospectively collect serial milk samples from 30 adult women who are treated with galcanezumab for migraine. Mothers who are interested in participating will be connected with us, the main clinical site, by neurologists across the USA. Mothers must carry a diagnosis of migraine, be aged 18-45 years, and be between 14 days and 9 months postpartum, and still nursing, at the time of enrollment.\n\nThis study will fill a significant unmet need as women of childbearing potential are over-represented in the migraine population, and yet they are excluded from clinical trials of migraine treatments during pregnancy and lactation.",[29],[203,204,29,205,206,207,208,209,210],"Emgality","Galcanezumab","Breastmilk","Milk","Breastfeeding","Pregnancy","Postpartum","Monoclonal Antibodies","2026-08-07",{"date":213,"type":43},"2026-08-11",{"date":215,"type":43},"2024-02-26",{"date":217,"type":22},"2028-04",{"name":219,"class":50},"University of California, San Francisco",{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":230,"briefSummary":231,"conditions":232,"keywords":233,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":255},"100638197","study-of-evo756-in-adults-with-migraine-100638197","NCT07616128","Study of EVO756 in Adults With Migraine","A Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of EVO756 for the Prevention of Migraine in Adults","Key Inclusion Criteria:\n\n* Adults aged 18 to \\\u003C65 years\n* Migraine with or without aura, per ICHD-3 criteria\n* History of failure with prior preventive migraine treatments\n* Not currently using migraine preventive therapy\n\nKey Exclusion Criteria:\n\n* Difficulty distinguishing migraine from other headache types or presence of other primary headache disorders\n* Use of certain medications\n* Any clinically significant medical, psychiatric, neurological, cardiovascular, or laboratory abnormalities","64 Years",{"count":229,"type":22},330,[176],"This study will evaluate the efficacy and safety of EVO756 against placebo in adults with migraine.",[29],[234,235,236,116,237,29,238,239,240,241,242,243,244,245,246],"Migraine Disease","Migraine Disorder","Migraine Disorders","Migraine Headaches","Migraines","Migraine in Adults","Migraine Prophylaxis","Migraine With Aura","Migraine With or Without Aura","Migraine With and Without Aura","Migraine Without Aura","Episodic Migraine Headache","Chronic Migraine Headache","2026-08-06",{"date":181,"type":43},{"date":250,"type":43},"2026-07-29",{"date":252,"type":22},"2027-11",{"name":254,"class":74},"Evommune, Inc.",20,{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":18,"minAge":264,"maxAge":85,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":267,"briefSummary":268,"conditions":269,"keywords":271,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":279,"leadSponsor":281,"locationsCount":51},"100632436","headache-education-and-awareness-vs-daily-mindfulness-strategies---understanding-pain-100632436","NCT07513662","Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain","Feasibility Trial of a Remotely-Delivered Mindfulness-Based Intervention for Adolescents With Migraine","HEADS-UP","Inclusion Criteria:\n\n* Age 12 to 17 years old\n* Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition\n* Patient report of at least 6 headache days per month\n* At least mild headache-related disability, as assessed by PedMIDAS score \\> 10\n* Stable dose (≥4 weeks) of prophylactic migraine medication or no current prophylactic medication at enrollment\n* Adolescent participant fluent in English for the intervention content\n\nExclusion Criteria:\n\n* Currently engaged in, or previously received 4 or more sessions of behavioral interventions for pain management (e.g., mindfulness or cognitive-behavioral therapy) in the past 6 months\n* Current psychiatric crisis (e.g., active suicidal ideation)\n* Cognitive impairments or developmental delays that interfere with their ability to participate in the study\n* Inability to provide consent\u002Fassent","12 Years",{"count":266,"type":22},72,[25],"The goal of this study (supported by and included in the NIH HEAL Initiative: https:\u002F\u002Fheal.nih.gov\u002F) is to learn if a fully virtual study comparing two telehealth group interventions for adolescents with migraine is feasible and acceptable:\n\n1. Telehealth group mindfulness-based intervention\n2. Telehealth group headache education",[29,270],"Migraine in Adolescence",[272,273,274,29,180,275,276],"Adolescent","Mindfulness","Mindfulness Intervention","Headache Education","Randomized controlled trial",{"date":181,"type":43},{"date":129,"type":22},{"date":280,"type":22},"2028-12",{"name":282,"class":50},"University of Colorado, Denver",{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":18,"minAge":290,"maxAge":85,"enrollmentInfo":291,"targetDuration":4,"studyType":23,"phases":293,"briefSummary":294,"conditions":295,"keywords":299,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":314},"100507610","responding-with-evidence-and-access-for-childhood-headaches-100507610","NCT05889624","Responding With Evidence and Access for Childhood Headaches","Cognitive Behavioral Therapy Via Telehealth + Amitriptyline Compared to Cognitive Behavioral Therapy Via Telehealth: Pediatric Migraine Prevention (Responding With Evidence and Access for Childhood Headaches)","Inclusion Criteria:\n\n* Diagnosis: Migraine with or without aura that meets the International Classification of Headache Disorders (ICHD) criteria 5 or presentation of continuous headache that includes migranous episodes based upon headache history obtained by site PI or designee. (includes presentation with or without medication overuse headache as well)\n* Headache Frequency: 4 or more headache days based upon prospective headache diary of 28 days prior to randomization\n* Amitriptyline Eligible: Site PI or medical staff determined participant to be eligible for clinical prescription of amitriptyline as a preventive treatment for migraine\n* English fluency: Able to complete the study visits and questionnaires in English\n\nExclusion Criteria:\n\n* Current treatment includes amitriptyline and\u002For CBT specific to headache care\n* Current prescribed preventive antimigraine medication within a period equivalent to \\\u003C 5 half-lives of that medication before entering the baseline phase\n* Current treatment with onabotulinumtoxinA (Botox) or CGRP-based monoclonal antibody medications for migraine prevention\n* Youth who are pregnant\n* Report of current or ongoing suicidal thoughts. Suicide attempt within the past six months. History of bipolar disorder, prolonged QT, or pre-existing significant constipation or gastroparesis\n* Any and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the participant","10 Years",{"count":292,"type":22},400,[25],"This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone.",[180,296,297,29,236,241,244,298],"Headache Disorders","Headache, Migraine","Chronic Migraine",[120,119,300,301,302,303,304,305,306],"cognitive behavioral therapy","pediatrics","diaphragmatic breathing","progressive muscle relaxation","imagery","relaxation","biofeedback",{"date":181,"type":43},{"date":309,"type":43},"2023-08-22",{"date":311,"type":22},"2027-12-31",{"name":313,"class":50},"Children's Hospital Medical Center, Cincinnati",15,{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":140,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":322,"targetDuration":290,"studyType":144,"phases":4,"briefSummary":324,"conditions":325,"keywords":331,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":51},"100651108","headache-ear-auditory-dizziness-sinus-heads-registry-100651108","NCT07754266","Headache Ear Auditory Dizziness Sinus (HEADS) Registry","HEADS","Inclusion Criteria:\n\n* Resident of the United States of America\n* Age of Majority (18+ in 47 states and Washington, D.C., 19+ in Alabama and Nebraska, 21+ in Puerto Rico and Mississippi)\n* Fluent in English OR Spanish.\n* Experience sinus, vestibular auditory, and\u002For headache symptoms, with and without diagnosis of migraine.\n\nExclusion Criteria:\n\n* Under 18 years of age, under age of Majority. Minors are not the population of interest for the study at this time.",{"count":323,"type":22},10000,"The Headache, Ear, Auditory, Dizziness, Sinus (HEADS) Registry is a study over time of individuals living in the United States who experience sinus, vestibular, auditory, and headache symptoms. Through an online portal, participants are asked questions about their symptoms, how they have affected their lives, and how effectively they have managed them. This information is then used to better understand these symptoms and to improve patient diagnosis and treatment.\n\nSome potential research benefits of the HEADS Registry include:\n\n* Improving healthcare professionals' understanding of the causes of specific head and neck symptoms.\n* Reducing delays in diagnosis and the use of inappropriate tests, medications, and surgeries.\n* Finding the most effective treatments for sinus, vestibular, and auditory disorders.\n* Providing participants the opportunity to be contacted for additional important research related to sinus, vestibular, and auditory disorders.\n\nAll U.S. residents over the age of majority who experience sinus, vestibular, and auditory symptoms, with or without migraine, are eligible to participate. Enrollment is voluntary, confidential, and free of charge.",[296,326,327,328,329,236,180,29,330],"Dizziness","Vestibular Diseases","Sinus Disease","Vestibular Disorder","Facial Pain",[332,236,333,334,330,180],"Registries","Ear Diseases","Paranasal Sinus Diseases","2026-08-04",{"date":181,"type":43},{"date":338,"type":43},"2023-07-06",{"date":340,"type":22},"2033-12-31",{"name":188,"class":50},{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":141,"enrollmentInfo":349,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":353,"conditions":354,"keywords":355,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":366},"100590794","phase-4-comparative-effectiveness-of-migraine-preventive-medications-the-apt-comparison-study-100590794","NCT06972056","Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study","A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention: The APT Comparison Study","Inclusion Criteria:\n\n* Adults, 18-70 years of age at the time of enrollment\n* Migraine with aura, migraine without aura, and\u002For chronic migraine; according to ICHD-3 diagnostic criteria. (Those with daily or continuous headaches are not excluded.)\n* Migraine onset prior to 50 years of age\n* Migraine present for at least 12 months at the time of enrollment\n* At least four \"moderate to severe headache days\" per month (by patient self-report and then confirmed during four-week pre-randomization headache diary phase) A \"moderate to severe headache day\" is defined as a day during which there is a headache of moderate to severe intensity that lasts for at least four hours, or a day on which a migraine-specific acute medication is taken to treat headache.\n* If already taking a migraine preventive treatment, willing to continue with that treatment without dose change during the first 16 weeks of the study, including the 4-week run-in phase and 12-week randomized phase.\n* Not pregnant or breastfeeding\n* Women of childbearing potential must agree to use effective methods of contraception to reduce the risk of pregnancy.\n* Willingness and ability to provide informed consent.\n* Willingness and ability to complete all research visits.\n\nExclusion Criteria:\n\n* Contraindications to taking atogepant, propranolol, or topiramate.\n* Currently taking atogepant, propranolol, or topiramate\\*\n* Previously took atogepant, propranolol, or topiramate\\*\n* Unwillingness to take atogepant, topiramate, or propranolol.\n* Current use of a CGRP-targeting preventive medication or beta-blocker\n* Migraine with brainstem aura\n* Hemiplegic migraine\n* Retinal migraine\n* Migraine aura without headache (exclusively)\n* Pure menstrual migraine\n* Trigeminal autonomic cephalalgias\n* Facial neuralgias\n* Secondary headache disorders (medication overuse headache is not an exclusion)\n* Migraine preventive treatment has been started or dose has been changed within 12 weeks prior to potential enrollment.\n* Used opioids or butalbital on five or more days per month on average for at least 3 months prior to enrollment.\n* Current or past epilepsy\n* Severe hepatic impairment\n* Moderate or more severe renal impairment \\* Occasional as needed use of propranolol, currently or in the past, is not an exclusion, such as taking as needed propranolol for treatment of anxiety.",{"count":350,"type":22},1335,[352],"PHASE4","This goal of this study is to compare three medications used for migraine preventive treatment.\n\nThis study will compare atogepant, a newer migraine preventive medication, with two older preventive medications, topiramate and propranolol. It will be determined if one works better and is more tolerable than the others.\n\nResearch participants will:\n\n* Be randomly assigned to one of the three medications.\n* Provide information about their migraine pattern using a daily headache diary and during research visits.",[29],[29,356,357],"Migraine with aura","Migraine prevention",{"date":359,"type":43},"2026-07-30",{"date":361,"type":43},"2025-07-09",{"date":363,"type":22},"2029-12-01",{"name":365,"class":50},"Mayo Clinic",36,{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":85,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":376,"briefSummary":377,"conditions":378,"keywords":379,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":393},"100451276","phase-3-efficacy-and-safety-study-of-rimegepant-for-the-preventative-treatment-of-migraine-in-pediatric-subjects-100451276","NCT05156398","Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to \u003C18 Years of Age","Inclusion Criteria:\n\n1. Subject has at least a 6 month history of migraine (with or without aura) and including the following:\n\n   1. 14 or less headache days per month during the 3 month period prior to the Screening Visit\n   2. 6 or more migraine days during the Observation Period\n   3. 14 or less headache days during the Observation Period\n   4. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of \\>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit\n   5. Ability to verbally distinguish migraine attacks from tension\u002Fcluster or other types of headaches\n   6. Migraine attacks, on average, lasting 4 - 72 hours if untreated\n   7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to \\\u003C18 years; subjects must be less than 18 at the time of signing assent \u002F consent.\n\n      3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.\n\nExclusion Criteria:\n\n1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine\n2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.\n3. The subject has a history or diagnosis of complications of migraine\n4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.\n5. The subject has any current psychiatric condition that is uncontrolled and\u002For untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and\u002For mania are excluded.\n6. History of suicidal behavior or the subject is at risk of self-harm or harm to others.\n7. History of major psychiatric disorder.\n8. The subject has a current diagnosis or history of substance abuse\n9. The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.",{"count":375,"type":22},640,[63],"The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \\\u003C18 years with episodic migraine.",[29],[29,357,380,381,382,383,384],"Phonophobia","Photophobia","Nausea","Pediatric migraine","Adolescent migraine","2026-07-28",{"date":250,"type":43},{"date":388,"type":43},"2022-02-28",{"date":390,"type":22},"2032-11-27",{"name":392,"class":74},"Pfizer",90,{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":85,"enrollmentInfo":4,"targetDuration":4,"studyType":401,"phases":4,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":404,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":408,"locationsCount":4},"100327154","fremanezumab-managed-access-program-for-pediatric-patients-100327154","NCT03539393","Fremanezumab Managed Access Program for Pediatric Patients","Fremanezumab (TEV-48125) Compassionate Use Program for Pediatric Patients (6 to 17 Years) With Chronic or Episodic Migraine","Inclusion Criteria:\n\n* Eligible patients may enter this CUP after successfully completing TV48125-CNS-30084 and all End of Study procedures\n* In the opinion of your physician\u002Finvestigator are able to continue IMP (fremanezumab) in a safe and compliant way.\n\nExclusion Criteria:\n\n* Additional criteria may apply, please contact your physician\u002Finvestigator for more information.","EXPANDED_ACCESS","This is a Managed Access Program (MAP) based on a licensed physician's unsolicited request on a compassionate basis. Specifically, this MAP is for male and female pediatric patients 6 to 17 years with a diagnosis of either episodic or chronic migraine who have successfully completed the Teva sponsored study TV48125-CNS-30084 (SPACE study).",[29],"AVAILABLE","2026-07-23",{"date":407,"type":43},"2026-07-27",{"name":409,"class":74},"Teva Branded Pharmaceutical Products R&D LLC",{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":417,"enrollmentInfo":418,"targetDuration":4,"studyType":23,"phases":420,"briefSummary":421,"conditions":422,"keywords":423,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":435},"100642292","phase-2-study-evaluating-the-efficacy-safety-and-tolerability-of-asy202-dihydroergotamine-mesylate-dhe-inhalation-powder-delivered-via-a-multidose-dry-powder-inhaler-for-the-acute-treatment-of-migraine-in-adult-patients-100642292","NCT07646613","Study Evaluating the Efficacy, Safety, and Tolerability of ASY202 (Dihydroergotamine Mesylate [DHE] Inhalation Powder Delivered Via a Multidose Dry Powder Inhaler) for the Acute Treatment of Migraine in Adult Patients","A Randomized, Double-blind, Placebo-controlled, Crossover, Multi-center Clinical Trial for the Evaluation of Efficacy, Safety, and Tolerability of ASY202 for the Acute Treatment of Migraine in Adult Patients","Inclusion Criteria:\n\n* Able to understand study procedures and provide written informed consent\n* Male or female, 18-65 years of age at Screening\n* BMI between 18.5-35 kg\u002Fm² at Screening\n* Documented history of migraine (with or without aura) for ≥1 year, consistent with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)\n* Female participants must be either:\n\n  * of non-childbearing potential, or\n  * of childbearing potential using protocol required contraception\n\nExclusion Criteria:\n\n* Diagnosis of headache conditions other than migraine\n* History or current diagnosis of coronary artery disease (CAD)\n* History or current diagnosis of coronary artery vasospasm (including Printz-metal's angina), clinically significant arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation) or peripheral vascular disease, ischemic disease (e.g., Raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia)\n* History of percutaneous coronary intervention, cardiac surgery, sepsis or vascular surgery\n* History or current diagnosis of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, or subarachnoid hemorrhage\n* Known history or current diagnosis of psychological and\u002For psychiatric condition that, in the opinion of the Investigator, might interfere with study participation and assessments or participant safety. These conditions may include depression, psychosis, schizophrenia, bipolar disorder, dementia, alcoholism, drug abuse, etc.\n* Known allergic reactions, hypersensitivity, or contraindications to DHE, other ergot-derived products, or any other excipient in the formulation\n* Use of strong or moderate CYP3A4 inhibitors within 14 days (or 5 half-lives) or CYP3A4 inducers within 28 days (or 5 half-lives) prior to Randomization\n* Any clinically significant symptoms or conditions at screening, other than migraine, including but not limited to central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions, or history of such conditions that in the opinion of the Investigator, might interfere with study assessments or participant safety","65 Years",{"count":419,"type":22},108,[176],"This study is testing an investigational inhaled migraine medication to see how well it works, how safe it is, and how well people tolerate it. Adults with migraine will receive both the study medication (ASY202) and a placebo (inactive treatment) at different times during the study. Neither participants nor study staff will know which treatment is given at the time. The medication is taken using a handheld dry powder inhaler to treat migraine attacks when they occur.\n\nFollowing screening, eligible participants will be enrolled and randomized to one of two treatments sequences i.e. one treatment sequence will receive ASY202 in treatment period 1 followed by placebo in treatment period 2 and other treatment sequence will receive placebo in treatment period 1 followed by ASY202 in treatment period 2.\n\nThe study lasts about 16 weeks and includes a screening period, two treatment periods (with a minimum of 7 days washout period between the treatment periods), and a safety follow-up visit.",[29],[29,424,425],"DHE","Dihydroergotamine Mesylate","2026-07-20",{"date":428,"type":43},"2026-07-21",{"date":430,"type":43},"2026-05-19",{"date":432,"type":22},"2026-12",{"name":434,"class":74},"Aspeya, Inc.",6,{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":18,"minAge":444,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":447,"conditions":448,"keywords":450,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":366},"100562468","post-marketing-study-to-assess-the-safety-and-effectiveness-of-oral-atogepant-in-korean-adult-participants-for-the-prevention-of-chronic-or-episodic-migraine-100562468","NCT06603558","Post-Marketing Study to Assess the Safety and Effectiveness of Oral Atogepant in Korean Adult Participants for the Prevention of Chronic or Episodic Migraine","Post-marketing Surveillance Study to Evaluate the Safety and Effectiveness of Atogepant for the Prevention of Migraine in Korean Adult Patients","Atogepant PMSS","Inclusion Criteria:\n\n* Participants with migraine suitable for the treatment with atogepant according to the latest approved local label.\n* Participants prescribed atogepant in accordance with the approved local label.\n\nExclusion Criteria:\n\n* Participants with any contraindication to atogepant as listed on the latest approved local label.\n* Participants currently participating in another clinical research except observational study.","19 Years",{"count":446,"type":22},3000,"Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and\u002For sensitivity to light and sound. The study will assess the safety and effectiveness of atogepant for the preventive treatment of migraine in Korean adult patients with chronic migraine or episodic migraine under routine clinical practice.\n\nAtogepant is an approved drug for preventive treatment of migraine in adults. Approximately 3000 adult participants who are prescribed atogepant by their doctors will be enrolled in this study in Korea.\n\nParticipants will receive atogepant oral tablets as prescribed by their physician. Participants will be followed for up to week 12.\n\nThere is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.",[298,449,29],"Episodic Migraine",[298,449,29,451,452,453],"Atogepant","Qulipta","Aquipta",{"date":455,"type":43},"2026-07-22",{"date":457,"type":43},"2024-09-24",{"date":459,"type":22},"2029-05",{"name":101,"class":74},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":140,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":471,"conditions":472,"keywords":476,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":51},"100648193","optical-coherence-tomography-in-neurological-practice-utility-and-applicability-across-neurological-diseases-octinn-100648193","NCT07720765","Optical Coherence Tomography in Neurological Practice: Utility and Applicability Across Neurological Diseases (OCt.IN.N)","A National, Monocentric, Prospective Cohort Study to Evaluate the Utility and Applicability of Optical Coherence Tomography in Neurological Clinical Practice","OCT","Inclusion Criteria for neurological patients:\n\n1. Diagnosis of a Central Nervous System neurological disease (inflammatory diseases such as Multiple Sclerosis; neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease; migraine\u002Fheadache) according to currently accepted diagnostic criteria for each condition.\n2. Age greater than 18 years.\n3. Signed informed consent to study participation.\n4. Willingness and ability to undergo all study visits and procedures.\n\nInclusion Criteria for healthy controls:\n\n1. Absence of neurological disease.\n2. Age greater than 18 years.\n3. Signed informed consent to study participation.\n4. Willingness and ability to undergo all study visits and procedures.\n\nExclusion Criteria for neurological patients:\n\n1. Refusal to participate or withdrawal of informed consent.\n2. Known or confirmed ocular pathology identified during examination (ophthalmological evaluation may be requested at the investigators' discretion).\n3. Inability to understand instructions given by investigators.\n4. Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study.\n5. For specific imaging modes using clearly visible light sources (MultiColor, FA, BAF): diagnosis of epilepsy or history of previous epileptic seizures.\n\nExclusion Criteria for healthy controls:\n\n1. Refusal to participate or withdrawal of informed consent.\n2. Known or confirmed ocular pathology identified during examination.\n3. Inability to understand instructions given by investigators.\n4. Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study.",{"count":470,"type":22},1050,"OCt.IN.N is a national, monocentric, prospective, observational cohort study evaluating the utility and applicability of Optical Coherence Tomography (OCT) in the diagnostic workup and longitudinal monitoring of neurological diseases.\n\n840 patients with Central Nervous System neurological diseases (Multiple Sclerosis, Alzheimer's disease, Parkinson's disease, migraine\u002Fheadache) and 210 age-matched healthy controls will undergo OCT examination at baseline and at 6, 12, 18, and 24 months of follow-up at IRCCS San Raffaele Hospital, Milan, Italy.\n\nOCT is a non-invasive, rapid, and reproducible technique that automatically measures the thickness of individual retinal layers. Retinal layer thicknesses and their longitudinal changes will be correlated with established clinical scales, neuroimaging, and biological markers used in routine neurological practice.",[473,474,475,29,296],"Multiple Sclerosis","Alzheimer Disease","Parkinson Disease",[477,467,478,479,480,481,473,482,483,29,484,485,486],"Optical Coherence Tomography","Retinal nerve fiber layer","RNFL","Ganglion cell layer","GCL","Alzheimer's disease","Parkinson's disease","Neurodegeneration","Neuro-retina","Biomarker","2026-07-17",{"date":455,"type":43},{"date":490,"type":43},"2023-10-09",{"date":492,"type":22},"2031-04-01",{"name":494,"class":50},"IRCCS San Raffaele",{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":140,"sex":196,"minAge":264,"maxAge":197,"enrollmentInfo":503,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":505,"conditions":506,"keywords":508,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":51},"100576425","endometriosis-and-migraine-100576425","NCT06785129","Endometriosis and Migraine","Mechanisms Underlying Endometriosis and Migraine Comorbidity","EMC","Inclusion Criteria:\n\n1. Patients with diagnosed endometriosis, migraine, or both endometriosis and migraine\n2. Healthy control subjects with no history of chronic pain\n3. Age 12-45\n4. Assigned female sex at birth\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding\n2. Presence of prolactinoma\n3. Presence of psychiatric, neurological, endocrinological and\u002For developmental conditions and taking medications for these conditions\n4. Current use of dopamine agonist or SSRI medications\n5. For patients aged 12-17 not having a parent\u002Flegal guardian willing to sign the consent and answer surveys about their child's health",{"count":504,"type":22},120,"This study aims to determine differences in experimental pain and sex hormone levels between patients with migraine, patients with endometriosis, patients with migraine and endometriosis, and healthy controls. Participants will complete surveys, experimental pain paradigms and collection of samples for hormone analyses.",[29,507],"Endometriosis",[29,509,510,511],"endometriosis","hormones","pain","2026-07-10",{"date":514,"type":43},"2026-07-13",{"date":516,"type":43},"2025-02-12",{"date":518,"type":22},"2030-01-01",{"name":520,"class":50},"Washington University School of Medicine",{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":140,"sex":18,"minAge":290,"maxAge":527,"enrollmentInfo":528,"targetDuration":4,"studyType":23,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":533,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":51},"100489507","migraine-in-adolescents-100489507","NCT05654012","Migraine in Adolescents","Inclusion criteria for healthy participants:\n\n1. Age 10-13\n2. Males or females (biological sex)\n3. Not diagnosed with migraine or having migraine symptoms\n4. With a first degree relative diagnosed with migraine (for the Fam-His group) or without a first or a second degree relative diagnosed with migraine (for the No-Fam-His group)\n\nInclusion criteria for participants with migraine:\n\n1. Age 10-13\n2. Males or females (biological sex)\n3. Diagnosed with migraine or having migraine symptoms\n4. Migraine duration \\> 6 months\n5. Without preventative treatment or with stable preventative treatment for migraine (no change in intervention in the last 6 months)\n\nExclusion Criteria for the healthy group:\n\n* Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion:\n\n  1. Diagnosis of any chronic pain syndrome\n  2. Diagnosis of a neurological, developmental, pubertal, or psychiatric disorder\n  3. Taking pain or psychiatric medications regularly\n  4. Having an MRI contraindication such as metal in the body or claustrophobia\n  5. Not able to understand and communicate in English\n\n     Exclusion Criteria for the migraine group\n* Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion:\n\n  1. Diagnosis of any chronic pain syndrome other than migraine\n  2. Diagnosis of a neurological, developmental, pubertal, or psychiatric disorder\n  3. Having an MRI contraindication such as metal in the body or claustrophobia\n  4. Not able to understand and communicate in English","13 Years",{"count":529,"type":22},250,[25],"Aim 1. To identify psychophysical and neural factors predicting migraine onset in adolescents\n\nAim 2a. To determine hormonal, psychophysical, and neural changes associated with migraine onset.\n\nAim 2b. To identify the temporal relationships between hormonal, psychophysical, and neural changes preceding vs. following migraine onset.\n\nAim 3. To identify psychophysical and neural factors predicting migraine prognosis in adolescents with migraine.",[29],{"date":514,"type":43},{"date":535,"type":43},"2023-06-01",{"date":537,"type":22},"2030-03-15",{"name":520,"class":50},{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":140,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":548,"conditions":549,"keywords":550,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":4},"100646085","tear-biomarkers-for-migraine-100646085","NCT07690696","Tear Biomarkers for Migraine","Novel Diagnostic and Treatment Response Biomarkers in Tear Fluid of Migraine Patients","TEAR","Inclusion criteria patients with migraine\n\n* Male or female participants aged ≥ 18 years;\n* Diagnosis of migraine according to International Classification of Headache Disorders (ICHD) criteria;\n* Clinical indication, according to routine practice, for treatment with anti-CGRP monoclonal antibodies or gepants (only for the longitudinal subgroup);\n* Ability and willingness to provide written informed consent. Inclusion criteria for healthy controls\n* Male or female participants aged ≥ 18 years;\n* Subjects, without migraine;\n* Ability and willingness to provide written informed consent.\n\nExclusion criteria (for both patients with migraine and healthy controls)\n\n* Fulfillment of ICHD diagnostic criteria for secondary headaches;\n* Active inflammatory ocular diseases;\n* Severe abnormalities in tear production;\n* Systemic inflammatory diseases that may interfere with biomarker interpretation.",{"count":292,"type":22},"The goal of this observational monocentric study is to investigate tear and serum biomarkers in patients with migraine compared with healthy controls, and to explore their potential diagnostic, clinical, and predictive value. In addition to the cross-sectional evaluation, a longitudinal subgroup analysis will be conducted to assess biomarker changes over time during treatment with anti- Calcitonin Gene-Related Peptide (anti-CGRP) therapies.",[29],[119,120,551,552,553,554,555,556],"tears","CGRP","PACAP-38","IL-10","IL-1β","TNF-α","2026-07-09",{"date":512,"type":43},{"date":560,"type":22},"2026-09-30",{"date":562,"type":22},"2029-09-29",{"name":564,"class":50},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":140,"sex":18,"minAge":571,"maxAge":141,"enrollmentInfo":572,"targetDuration":4,"studyType":23,"phases":574,"briefSummary":576,"conditions":577,"keywords":578,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":586,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":590,"locationsCount":51},"100551767","early-phase-1-mechanistic-studies-of-psilocybin-in-headache-disorders-100551767","NCT06464367","Mechanistic Studies of Psilocybin in Headache Disorders","Inclusion criteria:\n\n* Age 21 to 70 (inclusive)\n* Migraine disease per ICHD-3 criteria (for migraine participants) OR Healthy control patient\n\nExclusion criterion\n\n* Unstable medical condition or serious nervous system pathology\n* Pregnant, breastfeeding, lack of adequate birth control\n* Psychotic or manic disorder\n* Substance abuse in the prior 3 months\n* Use of classic psychedelics (e.g., psilocybin, LSD, mescaline) in the past 6 months\n* Use of cannabis or other THC products in the prior 2 weeks\n* Urine toxicology positive to drugs of abuse\n* The use of triptans (e.g., sumatriptan) or ditans (e.g., lasmiditan) more than twice weekly on average\n* Use of serotonergic preventive therapies (i.e., taken chronically; amitriptyline, fluoxetine, imipramine, cyproheptadine) in the past 6 weeks\n* Use of preventive or transitional treatments that produce spikes and waning of symptom relief (e.g., botulinum toxin, calcitonin gene-related peptide system targeting antibodies, peripheral nerve or ganglion blocks, chiropractic manipulation)\n* History of a bleeding disorder or are currently taking anticoagulants (e.g., warfarin, enoxaparin, dabigatran, apixaban).\n* Use of non-steroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen) in the 7 days before PET scan and 7 days after PET scan.","21 Years",{"count":573,"type":22},50,[575],"EARLY_PHASE1","In previous clinical trial work, the investigators observed lasting reductions in headache burden after limited dosing of psilocybin. This purpose of this study is to examine potential sources for this observed effect. This study will measure brain resting state functional connectivity (fMRI), central synaptic density (SV2A PET), peripheral markers of inflammation, circadian rhythm (actigraphy), and sleep (sleep EEG) in both migraine and healthy control participants before and one week after the administration of psilocybin or an active control agent.",[29],[579,580,581,582,583,584,585],"psilocybin","resting state functional connectivity","synaptic density","synaptic vessel glycoprotein 2A (SV2A)","circadian rhythm","sleep","inflammation",{"date":514,"type":43},{"date":588,"type":43},"2025-05-19",{"date":311,"type":22},{"name":591,"class":50},"Yale University",{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":18,"minAge":264,"maxAge":4,"enrollmentInfo":599,"targetDuration":600,"studyType":144,"phases":4,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":615},"100464994","china-headache-disorders-registry-100464994","NCT05334927","China HeadAche DIsorders RegiStry","CHAIRS","Inclusion Criteria:\n\n1. Age ≥ 12 years old,Any gender;\n2. The first onset age of primary headache was less than 50 years old(Age \\\u003C65 years at first diagnosis of chronic migraine);\n3. patients with primary headache (migraine, tension headache and other types of primary headache) or primary headache complicated with MOH according to ICHD-3;\n4. Sign the informed consent form.\n\nExclusion Criteria:\n\n1. According to the ICHD-3 diagnostic criteria, there are still headaches directly related to secondary factors (except drug overuse) at the time of enrollment;\n2. Those who cannot be diagnosed as primary headache or primary headache combined with medication overuse headache according to ICHD-3;\n3. According to DSM-V diagnostic criteria, patients with severe mental diseases (such as schizophrenia, mental disorders associated with mental retardation, etc.);\n4. Patients with severe organic diseases, such as malignant tumors, and the expected survival time is less than 1 year;\n5. Pregnant,planning pregnancy or Lactating women;\n6. Subjects participating in other clinical trials;\n7. Unable to cooperate to complete the follow-up due to geographical or other reasons",{"count":323,"type":22},"1 Month","It is planned to include 10000 patients. In the China HeadAche DIsorders RegiStry CHAIRS）, patients aged over 12 years with primary headache and medication-overuse headache(MOH) were collected. The biomarkers, imaging features, cognition, genetic characteristics, ocial and demographic data, medical data, therapeutics used, and outcome of headache-related diseases were studied, and long-term follow-up was planned.",[603,29,604,605,606,607],"Headache Disorders, Primary","New Daily Persistent Headache","Medication Overuse Headache","Tension-Type Headache","Trigeminal Autonomic Cephalalgia",{"date":512,"type":43},{"date":610,"type":43},"2022-08-29",{"date":612,"type":22},"2032-12-31",{"name":614,"class":50},"Beijing Tiantan Hospital",61,{"id":617,"slug":618,"hasResults":12,"nctId":619,"briefTitle":620,"officialTitle":621,"acronym":622,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":417,"enrollmentInfo":624,"targetDuration":4,"studyType":23,"phases":626,"briefSummary":627,"conditions":628,"keywords":629,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":638,"completionDateStruct":640,"leadSponsor":642,"locationsCount":51},"100646239","online-hatha-yoga-program-as-an-add-on-therapy-for-episodic-high-frequency-migraine-100646239","NCT07694063","Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine","A Randomized Controlled Trial of an Online Hatha Yoga Program as an Add-On Therapy for Episodic High-Frequency Migraine","MIGRANE-YOGA","Inclusion Criteria\n\n* Adults aged 18-65 years\n* Diagnosis of episodic high-frequency migraine according to ICHD criteria\n* Diagnosis confirmed by a neurologist\n* At least 1-year history of migraine\n* Receiving stable pharmacological treatment for ≥3 months before enrollment\n* Willing to maintain stable medication during the study\n* Ability to understand study procedures and complete assessments\n* Signed informed consent\n* Willingness to be randomized\n\nExclusion Criteria\n\n* Other significant neurological disorders\n* Severe psychiatric conditions affecting participation\n* Medical contraindications to moderate physical activity\n* Chronic migraine (≥15 headache days\u002Fmonth)\n* Use of more than one preventive migraine medication\n* Lack of Spanish language comprehension\n* Lack of internet access or digital skills for online intervention",{"count":625,"type":22},60,[25],"This randomized controlled trial aims to evaluate the effectiveness and feasibility of an online Hatha yoga program as an adjunct (add-on) therapy for patients with high-frequency episodic migraine. Participants will be randomly assigned to either an intervention group receiving a 12-week home-based online Hatha yoga program in addition to usual pharmacological treatment, or a control group receiving usual pharmacological care only. Outcomes include migraine frequency, pain intensity, functional disability, sleep quality, psychological symptoms, and adherence.",[29],[29,630,631,632,633,634,120,635],"Hatha yoga","Exercise therapy","Non-pharmacological intervention","randomized controlled trial","online intervention","complementary therapy","2026-07-06",{"date":557,"type":43},{"date":639,"type":43},"2026-01-27",{"date":641,"type":22},"2026-10-30",{"name":643,"class":50},"University of Seville",{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":650,"eligibilityCriteria":651,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":652,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":654,"conditions":655,"keywords":656,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":658,"startDateStruct":660,"completionDateStruct":662,"leadSponsor":664,"locationsCount":4},"100646503","study-to-assess-effectiveness-of-oral-atogepant-in-adult-participants-for-prevention-of-migraine-in-the-united-kingdom-100646503","NCT07690215","Study to Assess Effectiveness of Oral Atogepant in Adult Participants For Prevention of Migraine in the United Kingdom","Patient-Reported Outcomes and Healthcare Resource Use in Patients Initiated With Atogepant in a Primary Care Setting for the Prevention of Migraine: An Ambi-spective Real-World Study in the UK (PRACTICE)","PRACTICE","Inclusion Criteria:\n\n* Physician-confirmed diagnosis of migraine, classified as either episodic or chronic.\n* Have at least 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders 3rd edition (ICHD-3), 2018.\n* Without prior exposure to atogepant who are being prescribed atogepant in primary care for the prophylaxis of migraine with at least 4 migraine days per month.\n* Decision to initiate atogepant was made by a prescribing general practitioner (GP) or appropriate primary care health care professional (HCP) within a primary care setting, prior to and independent of any decision to approach the patient regarding participation in the study.\n* Willing and able to comply with the requirements of the study, including being able to read and comprehend written English at a level sufficient to understand and complete study patient-reported outcomes (PROs).\n* Not on concomitant preventive medication for migraine or have been on a stable preventive medication for migraine for at least 3 months prior to enrolment.\n* Access to a suitable device (e.g., laptop, tablet, or smartphone) to complete PRO measures.\n\nExclusion Criteria:\n\n* Previously exposed to atogepant as routine therapy before the study period or from clinical trials experience prior to entry.\n* Enrolled in any interventional studies that may include investigational compounds for migraine.\n* Initiated on atogepant in secondary care and subsequently maintained in primary care.\n* Initiated on atogepant in primary care following specialist input via an 'advice and guidance' pathway.\n* Contraindications to atogepant administration as per local labelling.\n* Pregnant or planning to be pregnant or women of childbearing potential not using contraception.\n* In the opinion of the prescribing GP or appropriate primary care HCP, the patient has a history or current evidence of any condition that might interfere with the patient's ability to comply with the study requirements.",{"count":653,"type":22},200,"Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and\u002For sensitivity to light and sound. The study will assess the effectiveness of atogepant for the preventive treatment of migraine in adult patients in the UK.\n\nAtogepant is an approved drug for preventive treatment of migraine in adults. Approximately 200 adult participants who are prescribed atogepant by their doctors will be enrolled in this study in the UK.\n\nParticipants will receive atogepant oral tablets as prescribed by their physician. Participants will be followed for up to week 48.\n\nThere is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.",[29],[29,298,449,451,453],"2026-07-02",{"date":659,"type":43},"2026-07-08",{"date":661,"type":22},"2026-09-01",{"date":663,"type":22},"2028-03",{"name":101,"class":74},{"id":666,"slug":667,"hasResults":12,"nctId":668,"briefTitle":669,"officialTitle":670,"acronym":671,"eligibilityCriteria":672,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":417,"enrollmentInfo":673,"targetDuration":675,"studyType":144,"phases":4,"briefSummary":676,"conditions":677,"keywords":678,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":694,"lastUpdatePostDateStruct":695,"startDateStruct":696,"completionDateStruct":698,"leadSponsor":700,"locationsCount":702},"100551404","study-for-prevent-chronification-migraine-through-prediction-of-response-to-treatment-with-anti-cgrp-antibodies-100551404","NCT06459648","Study for Prevent Chronification Migraine Through Prediction of Response to Treatment With Anti-CGRP Antibodies","Prediction Study or Response to Treatment With Anti-CGRP Monoclonal Antibodies in Migraine","PREDI-CGRP","Inclusion Criteria:\n\n* Patients aged between 18 and 65 years.\n* Caucasian ethnicity.\n* Patients diagnosed with migraine with and without high-frequency episodic aura (more than 8 days of migraine per month) or chronic by a neurologist expert in headaches and according to the criteria proposed in the International Classification of Headache Diseases, 3rd edition (ICHD- 3).\n* Have at least one year of history of migraine.\n* Patients must maintain stable preventive treatment in the previous month and not have received botulinum toxin in the month prior to starting the monoclonal antibody.\n* Patients able to describe their clinical situation and the characteristics of their headache.\n* Grant your informed consent.\n\nExclusion Criteria:\n\n* Patients who present with another type of non-migraine headache, with the exception of headache due to excessive use of analgesic medication.\n* Neurological focus in the examination.\n* Pregnancy or breastfeeding period.\n* Patients with cognitive deficiency or pathology that may prevent or hinder the correct completion of the study.\n* Patients who require changes in preventive treatment during the first 6 months after starting treatment with monoclonal antibodies.\n* Patients who present any significant adverse effect that requires withdrawal or change of anti-CGRP drug.",{"count":674,"type":22},350,"18 Months","Being able to predict each patients response to a specific treatment can mean a significant improvement in socioeconomic costs, but above all in their quality of life. With the present study, the investigators aim to analyze in a combined way different clinical, biological and neuroimaging variables, which allow the clinical staff to anticipate the response to treatment with anti-CGRP monoclonal antibodies in patients with migraine.",[29],[29,120,679,680,681,682,683,684,685,686,687,688,689,690,691,692,693],"antibodies","antibody","monoclonal antibody","anti-cgrp","anti cgrp","cgrp","prediction","treatmen","migraine treatment","treatment with anti-CGRP monoclonal antibodies","anti-cgrp antibodies","anti-cgrp antibody","anti-cgrp monoclonal antibodies","migraine and antibodies","migraine and cgrp","2026-06-30",{"date":657,"type":43},{"date":697,"type":43},"2023-04-26",{"date":699,"type":22},"2026-07",{"name":701,"class":50},"Fundación de Investigación Biomédica - Hospital Universitario de La Princesa",7]