[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-treatment-of-migraine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-treatment-of-migraine":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,69,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100646886","phase-4-a-study-to-find-out-if-the-medicine-called-rimegepant-is-safe-for-adults-in-india-100646886",false,"NCT07685769","A Study to Find Out if the Medicine Called Rimegepant is Safe for Adults in India","AN OPEN-LABEL MULTICENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF RIMEGEPANT 75 MG ODT FOR ACUTE TREATMENT OF MIGRAINE IN ADULT PARTICIPANTS IN INDIA WITH PREVIOUS INSUFFICIENT RESPONSE TO TRIPTANS","Inclusion Criteria\n\nParticipants are eligible to be included in this study only if all of the following criteria apply:\n\nAge and Reproductive Status:\n\n1. 18 years of age or older who meet the reproductive criteria.\n\n   Disease Characteristics:\n2. Participant has at least a 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:\n\n   1. At least 5 attacks fulfilling criteria 1-3:\n\n      1. Headache attacks lasting 4-72 hours (when untreated or unsuccessfully treated).\n      2. Headache has at least 2 of the following 4 characteristics:\n\n         * Unilateral location\n         * Pulsating quality\n         * Moderate or severe pain intensity\n         * Aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)\n      3. During headache, at least 1 of the following:\n\n         -Nausea and\u002For vomiting\n         * Photophobia and phonophobia\n   2. Not better accounted for by another ICHD-3 diagnosis.\n3. Participants experience 4-14 migraine days \u002F month and fewer than 7 non-migraine headache days \u002F month on average and overall, less than 15 days with headache (migraine or non-migraine) per month across the 3 months prior to screening.\n4. Participants on prophylactic migraine medication (non-CGRP) are permitted to remain on therapy if they have been on a stable dose for at least 3 months prior to screening visit, and the dose is not expected to change during the study.\n5. Participants have previous insufficient response and\u002For prior intolerance to at least one triptan or documented contraindication to the use of triptan.\n\n   1. Insufficient response - Previous treatment with one or more triptan has yielded no, unsatisfactory or inconsistent therapeutic effect (eg, recurrent, incomplete relief of migraine related symptoms \\[including pain, nausea, photophobia, phonophobia etc\\] at 2 hours post dose, non-sustained relief of migraine related symptoms through 24 hours post dose, etc), after repeated dosing (≥2 attempts) at recommended dose level.\n   2. Prior intolerance - treatment with triptan has been interrupted because of an adverse event that made continuation of the drug intolerable for the individual.\n\n      -Prior triptan associated overuse headache\n\n      -Arrhythmia associated with prior triptan use\n\n      -Chest\u002Fthroat\u002Fneck\u002Fjaw pain, tightness, pressure or heaviness associated with prior use of triptan\n\n      -Gastrointestinal ischemia or peripheral vasospastic reaction associated with prior use of triptan\n      * Serotonin syndrome associated with prior triptan use\n   3. Documented contraindication to triptans -\n\n      1. Documented hypersensitivity to triptan\n      2. Cardiovascular events, conditions and procedures considered contraindications to the use of triptan medications.\n\n   i. Events: Myocardial infractions, prior cardiac arrest, transient ischemic attack, cerebrovascular accident (Intracerebral haemorrhage, intracranial haemorrhage, subarachnoid haemorrhage, ischemic stroke) ii. Conditions: Angina pectoris, coronary artery vasospasm, ischemic coronary artery disease, peripheral artery disease, ischemic bowel disease, cardiac conduction disorders (life threatening arrhythmia\u002Fheart block) iii. Procedure: Angioplasty, coronary artery bypass grafting, carotid endarterectomy 3) Uncontrolled hypertension\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions:\n\n1. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n\n   * PHQ-8 total score ≥15\n   * Suicidal ideation and behavior (one, or more, of the below is exclusionary):\n\n     * a positive response to item 1 or 2 of the C-SSRS within 30 days prior to Screening;\n     * suicidal ideation associated with actual intent and\u002For a method or plan at any time in their lifetime: any positive response on items 3, 4 or 5 of the C-SSRS;\n     * any previous lifetime history of suicidal behavior: \"Yes\" to answer to any of the suicidal behavior items of the C-SSRS.\n   * Current diagnosis of schizophrenia, bipolar, or borderline personality disorder.\n   * History of severe drug allergy, including anaphylaxis or known hypersensitivity or intolerance to rimegepant or any of its excipients.\n2. Any of the following:\n\n   * History of any trigeminal autonomic cephalalgia (eg. cluster headache, Short-lasting, Unilateral, Neuralgiform headache attacks with Conjunctival injection and Tearing \\[SUNCT\\], Short-lasting unilateral neuralgiform headache attacks with cranial autonomic symptoms \\[SUNA\\], hemicrania continua, paroxysmal hemicrania).\n   * Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome \\[CRPS\\]); Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety.\n\n   Prior\u002FConcomitant Therapy:\n3. Current use of any prohibited concomitant medication(s).\n4. History of use of ergotamine medications or triptans for greater than\u002Fequal to 10 days per month on a regular basis for greater than\u002Fequal to 3 months, or history of non-narcotic analgesic intake for greater than\u002Fequal to 15 days per month for greater than\u002Fequal to 3 months (eg, acetaminophen, non-steroidal anti-inflammatory drugs \\[NSAIDs\\], gabapentin) for other pain indications.\n\n   Prior\u002FConcurrent Clinical Study Experience:\n5. Participation in clinical trial with non-biological investigational agents or interventional treatments (last study visit occurring) within the 30 days or 5 half-lives of investigational drug (whichever is longer) prior to Baseline Visit. Participation in clinical trial with biological investigational agents (last study visit occurring) within 90 days or 5 half-lives (whichever is longer) prior to Baseline Visit. Participation in any other investigational clinical trial while participating in this clinical trial.\n\n   Diagnostic Assessments:\n6. ANY of the following findings at the Screening Visit and laboratory tests as assessed by the study-specific laboratory:\n\n   * eGFR (using CKD-EPI-Scr-Scys Combined) \\\u003C30 mL\u002Fmin\u002F1.73m²\n   * Total bilirubin \\>1.5 × ULN (may be repeated once, with fractionation, for confirmation during the Screening Phase, and direct bilirubin \\>ULN is exclusionary if Gilbert's syndrome is suspected)\n   * AST (SGOT) or ALT (SGPT) \\>2.0 × ULN\n\n   Other Exclusion Criteria:\n7. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This is a multicenter, single-arm, open-label Phase 4 study evaluating the safety and tolerability of rimegepant 75 mg orally disintegrating tablet (ODT) for the acute treatment of migraine (with or without aura) in adult patients in India who have had an insufficient response, intolerance, or contraindication to triptans. It will enroll approximately 60 participants.",[26],"Acute Treatment of Migraine",[28,29],"migraine","Rimegepant","RECRUITING","2026-08-19",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":34},"2026-07-24",{"date":38,"type":20},"2028-01-04",{"name":40,"class":41},"Pfizer","INDUSTRY",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100419547","phase-3-long-term-safety-study-of-rimegepant-in-pediatric-subjects-for-the-acute-treatment-of-migraine-100419547","NCT04743141","Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine","Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to \u003C 18 Years of Age","Inclusion Criteria:\n\n1. History of migraine (with or without aura) for ≥ 6 months before Screening.\n2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.\n3. 1 or more migraine days requiring treatment during the Observation Phase.\n4. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.\n5. Ability to distinguish between migraine and other types of headaches.\n6. Weight \\> 15 kg. For EU countries only: Participants 12 to \\\u003C 18 years of age must have a body weight of \\>25kg.\n7. Adequate venous access for blood sampling.\n8. Male and female participants 6 to \\\u003C 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).\n\nExclusion Criteria:\n\n1. History of cluster headache or hemiplegic migraine headache.\n2. Confounding and clinically significant pain syndrome.\n3. Current uncontrolled and\u002For untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and\u002For mania are excluded).\n4. History of suicidal behavior or at risk of self-harm\u002Fharm to others.\n5. History of major psychiatric disorder.\n6. Current diagnosis or history of substance abuse\n7. Reported current use of or tested positive at Screening for drugs of abuse.","6 Years","17 Years",{"count":53,"type":20},600,[55],"PHASE3","The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \\\u003C 18 years of age).",[26],[59],"Long-term safety, acute treatment, migraine, phonophobia, photophobia, nausea, pediatric, children, adolescent","2026-08-13",{"date":62,"type":34},"2026-08-14",{"date":64,"type":34},"2021-04-28",{"date":66,"type":20},"2030-07-31",{"name":40,"class":41},124,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100643737","phase-4-a-study-to-learn-about-the-safety-of-taking-an-additional-dose-of-the-medicine-rimegepant-in-adults-with-migraine-100643737","NCT07609914","A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine","A PHASE 4, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF REDOSING OF RIMEGEPANT IN PARTICIPANTS 18 YEARS OF AGE OR OLDER FOR THE ACUTE TREATMENT OF MIGRAINE","Inclusion:\n\n* Eligible participants include adult participants aged 18 years of age or older with a minimum 1-year history of migraine (with or without aura) consistent with International Classification of Headache Disorders, 3rd Edition\n* Eligible participants must be currently using acute migraine treatment in accordance with the local label and have all of the following on average across the 12 weeks prior to the Screening Visit and, during the first 28 days of the observation phase (OP): (1) 6-14 monthly migraine days (MMDs); (2) \\\u003C15 monthly headache days (MHDs) (migraine or non-migraine); and (3) \\\u003C7 monthly non-migraine headache days.\n\nExclusion:\n\n* Participants with headaches occurring ≥15 days per month (migraine or non-migraine) on average across the 12 weeks prior to the Screening Visit and ≥7 non-migraine headache days per month on average across the 12 weeks prior to the Screening Visit would not be eligible.",{"count":77,"type":20},400,[23],"Acute treatments for migraine may not provide sufficient pain relief after an initial dose, and a second dose of a given medication may be needed to fully abort an attack. International Headache Society (IHS) global practice recommendations for the Acute Treatment of Migraine suggest a second dose of the same medication within the recommended dose limit in people with headache relapse after successful initial treatment of a migraine attack.\n\nThe primary purpose of this study is to evaluate the safety and tolerability of redosing of rimegepant when taken for the acute treatment of a migraine attack, as it is possible that some patients may benefit from a second dose of rimegepant in this setting.",[26],"2026-07-28",{"date":83,"type":34},"2026-07-29",{"date":85,"type":34},"2026-05-28",{"date":87,"type":20},"2028-05-15",{"name":40,"class":41},11,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":102,"conditions":103,"keywords":104,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100592615","phase-1-a-study-to-learn-about-the-study-medicine-called-zavegepant-pf-07930207-in-children-with-a-history-of-migraine-100592615","NCT06995729","A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine","A PHASE 1, MULTICENTER, OPEN-LABEL, SINGLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF ZAVEGEPANT IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH HISTORY OF MIGRAINE","Inclusion Criteria:\n\n1. Participants aged 6 years to less than 12 years.\n2. Documented medical history of migraine with or without aura for at least 6 months before the Screening Visit.\n3. Weight \\>15 kg at the Screening Visit\n\nExclusion Criteria:\n\n1. Evidence or history of clinically significant disease.\n2. Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.\n3. Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome.\n4. Conditions that may affect the administration or absorption of the nasal product\n5. Any psychiatric condition that is uncontrolled and\u002For untreated, including:\n\n   * Clinically significant depression (Promis Parent Proxy SF 2.0 Depressive Scale T score ≥70)\n   * Suicidal ideation and behaviour (C-SSRS: any \"yes\" to items 2 to 5 or any \"yes\" to suicide behaviours)\n6. Serum Total bilirubin \\>1.5 × ULN (Upper Limit of Normal), AST (Aspartate Transferase) or ALT (Alanine Transaminase) \\>2 × ULN\n7. Abnormal ECG (Electrocardiogram) at screening visit","11 Years",{"count":99,"type":20},16,[101],"PHASE1","The purpose of the study is to learn about safety and how the body processes the study medicine called Zavegepant (PF-07930207) in children with a history of migraine. This study helps understand how the medicine is changed and removed from the body after taking it.\n\nThis study is seeking participants who:\n\n* Are children aged between 6 and less than 12 years old\n* Have had migraine for at least 6 months.\n* Weigh more than 15 kilograms\n\nAll participants in this study will receive zavegepant as a nasal spray once (one spray into one nostril). The dose of the study medicine that each participant receives will depend on how much the participant weighs.\n\nThe study will look at the experiences of the participants receiving the study medicine and collect data to better understand the possible benefits and unwanted effects of different doses of the study medicine.\n\nParticipants will take part in this study for up to 10 weeks. During this time, they will have 3 study visits at the study clinic, and 2 follow-up phone calls.",[26],[28,105,106],"zavegepant","pediatric","2026-03-16",{"date":109,"type":34},"2026-03-18",{"date":111,"type":34},"2025-05-16",{"date":113,"type":20},"2027-08-12",{"name":40,"class":41},13]