[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659196":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":21,"studyPopulation":13,"armGroups":22,"interventions":29,"overallOfficials":13,"centralContacts":43,"locations":13,"responsibleParty":49,"collaborators":13,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":13,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":13,"enrollmentInfo":59,"targetDuration":13,"studyType":62,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":70,"whyStopped":13,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":13},{"fullName":5,"class":6},"American Center for Psychiatry and Neurology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of participants reporting pain relief at 2 hours post-dose following the first use of zavegepant for an acute migraine attack.","Pain relief is defined as a reduction of at least one category in pain intensity from baseline to the specified post-dose timepoint (e.g., severe to moderate, moderate to mild, or mild to none). The primary endpoint will be assessed based on the first treated acute migraine attack.","From enrollment to end of treatment at month 4",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"NA","SINGLE_GROUP","This is a single-arm interventional study with no comparator or control group. All enrolled participants receive intranasal zavegepant for the acute treatment of migraine in accordance with routine clinical practice.","TREATMENT",{"masking":20,"maskingDescription":13,"whoMasked":13},"NONE","This is a prospective, multicenter, interventional study conducted in a real-world setting, enrolling adult participants receiving zavegepant for the acute treatment of migraine. The study is classified as interventional due to the requirement for participants to complete protocol-mandated questionnaires and a patient diary. No protocol-specified therapeutic or diagnostic interventions are required. Participants management will otherwise follow routine clinical practice, and participants will receive study medication at no cost. Recruitment is planned from September 2026 through September 30, 2027. The index date is defined as the date on which the participant signs the Informed Consent Document (ICD). Eligible participants will receive a supply of study medication (up to 54 doses) at the index date. Additional medication may be provided at the investigator's discretion for participants with a higher frequency of migraine attacks, in accordance with study procedures.\n\nEach participant will be followed for approximately 4 months, including a 3-month treatment period and a 1-month follow-up period. Approximately 250 adult participants are planned for enrollment.Collected data will include demographics, migraine history, substance use, patient-reported headache episodes recorded in a paper diary, and patient-reported outcomes (PROs) documented in case report forms (CRFs). PRO assessments will be completed during on-site visits.\n\nTreatment Initiation: At the start of the treatment period, a one-week washout period is required prior to the first dose of zavegepant. During this period, participants should not use any acute migraine medications; however, short-acting triptans may be used as rescue medication if needed. Long-acting triptans (e.g., naratriptan and frovatriptan) must not be used. Participants without migraine attacks during the washout period may initiate treatment at their next migraine attack. Any ongoing preventive migraine treatments should remain stable throughout the washout period and the entire three-month treatment period. Treatment Administration and Migraine Attack Management: For the first three evaluable migraine attacks treated during the study, participants are required to complete the patient diary as described in section related to Patient Diary. Zavegepant should be administered only when the migraine headache reaches a moderate to severe level of pain. No other acute migraine medication should be taken prior to zavegepant administration. Rescue medication may be used if needed, but only ≥2 hours after dosing with zavegepant. For subsequent migraine attacks, participants may administer zavegepant at any time they consider appropriate, regardless of headache pain intensity or stage, including during mild pain or the prodromal phase (i.e., early symptoms indicating the onset of a migraine attack).\n\nAt Visit 1, participants will be dispensed a total of 54 doses of zavegepant, corresponding to a planned supply of 18 doses per month. This quantity is expected, in general, to cover treatment needs for the duration of the study. If a participant requires more than 18 doses within a given month, the Co-Investigator should notify the Principal Investigator to arrange additional supply in accordance with study procedures.\n\nThe primary assessment of effectiveness will focus on the first treated migraine attack, based on pain relief at 2 hours post dose.\n\nSecondary assessments will also include additional measures of effectiveness, including pain freedom, absence of the most bothersome symptom (MBS), resolution of associated symptoms, sustained pain response, return to normal function, and use of rescue medication.\n\nEffectiveness will be evaluated using patient-reported outcomes, including changes from Visit 1 to Visit 4 in headache impact (HIT-6), migraine-related disability (MIDAS), work productivity (WPAI: Migraine 2.0), and mood-related symptoms (PHQ-4 and GAD-7), as well as overall treatment improvement assessed by PGI-I at Visit 4.\n\nExploratory assessments will include early treatment response (up to 60 minutes post-dose), consistency of treatment effect across multiple attacks, and time to meaningful pain relief for the first treated attack. Analyses may include up to the first three evaluable migraine attacks treated with zavegepant, with a minimum 48-hour interval between treated attacks.\n\nRescue medication is defined as the use of any additional acute migraine treatment following zavegepant administration to manage insufficient symptom relief.\n\nAll analyses will be based on observed data; missing data will not be imputed. Denominators will be defined per endpoint. All study assessments are consistent with routine clinical practice or standard care for the target population.",[23],{"label":24,"type":6,"description":13,"interventionNames":25},"Not applicable as all the patients within the study will receive the same intervention",[26,27,28],"Other: Patient Headache Diary","Other: Patient Reported Outcome","Drug: intranasal zavegepant",[30,34,38],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":13},"Patient Headache Diary","Patients will be asked to provide information on the first 2-3 headache attacks during the study",[24],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":13},"Patient Reported Outcome","* Headache Impact Test (HIT-6) to assess the impact of headache on daily functioning and quality of life, collected at screening and V 4\n* Migraine Disability Assessment (MIDAS) to evaluate migraine-related disability and functional impairment, collected at screening and V 4\n* Patient Global Impression of Improvement (PGI-I) to assess the participants overall perception of treatment benefit, collected V 4\n* Work Productivity and Activity Impairment (WPAI: Migraine 2.0) questionnaire to evaluate the effect of migraine on work productivity and daily activities. collected at screening and V 4\n* The Patient Health Questionnaire-4 (PHQ-4) is used to assess the presence and severity of both depressive and anxiety symptoms, collected at screening and V 4\n* Generalized Anxiety Disorder-7 (GAD-7) to evaluate the presence and severity of anxiety symptoms, collected at screening and V 4 has context menu",[24],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":13},"DRUG","intranasal zavegepant","This intervention is free of charge for the participants of this trial.",[24],[44],{"name":45,"role":46,"phone":47,"phoneExt":13,"email":48},"Reem Suliman, MSc","CONTACT","+97124198039","research.officer@americancenteruae.com",{"type":50,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100659196","a-prospective-interventional-study-of-intranasal-zavegepant-for-the-acute-treatment-of-migraine-100659196",false,"NCT07861412","A Prospective Interventional Study of Intranasal Zavegepant for the Acute Treatment of Migraine","Inclusion Criteria:\n\n1. Participants diagnosed with migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd Edition, beta version\n2. Participants with history of migraine attacks, defined as at least 2 migraine attacks per month during the 3 months prior to screening\n3. Participants that signed the informed consent form\n4. Participants must be 18 years of age or older at the time of consent\n5. Participants must not be concurrently participating in another interventional clinical trial at the time of enrollment\n\nExclusion Criteria:\n\n1. Any previous exposure to zavegepant\n2. Females of child-bearing potential who are pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study\n3. Participants who, in the opinion of the investigator, are not suitable for study participation or are unable to comply with study procedures or complete the required one-month follow up, including due to severe visual, auditory, language, cognitive, or consciousness impairments\n4. Participants with history of nasal surgery in the 6 months preceding the screening visit\n5. Participants with evidence at screening of significant nasal conditions that may affect the administration or absorption of the nasal product (e.g. severe septum deviation, nasal deformity or blockage, inflammation, perforation, mucosal erosion or ulceration, polyposis, nasal trauma) as evaluated by the investigator\n6. Other conditions that, in the opinion of the investigator, may interfere with study participation, data quality, or the interpretation of study results, including but not limited to unstable psychiatric disorders, clinically significant or unstable cardiovascular conditions, or severe hepatic or renal impairment\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":60,"type":61},250,"ESTIMATED","INTERVENTIONAL",[15],"Primary Objective:\n\nTo evaluate the effectiveness of zavegepant in real-world settings for the acute treatment of migraine. Effectiveness will be evaluated based on the treatment of the first acute migraine attack with zavegepant, in order to capture clinically meaningful treatment response under real-world conditions while minimizing patient burden and missing data. Clinically meaningful treatment response is defined as: An improvement in a patient's condition that is large enough to be perceived as beneficial and to have a tangible impact on how the patient feels and functions.\n\nSecondary Objectives:\n\nTo further evaluate the effectiveness of zavegepant for the acute treatment of migraine in real-world settings, including:\n\n* Pain freedom\n* Absence of the patient-identified most bothersome symptom (MBS)\n* Absence of individual migraine-associated symptoms (phonophobia, photophobia, and nausea) at 1 hour and 2 hours post dose, among participants with symptoms present at baseline\n* Sustained pain relief\n* Return to normal function\n* Rescue medication use\n\nExploratory objectives include:\n\n* Evaluation of early treatment response at post-dose timepoints up to 60 minutes\n* Assessment of consistency of treatment effect across multiple migraine attacks\n* Time to meaningful pain relief as reported by the participant for the first treated attack\n\nPatient-Reported Outcomes:\n\nPatient-reported outcomes will be collected over a 3-month period to assess the longitudinal patient experience and sustained treatment impact in routine clinical practice.",[66],"Migraine",[66,68,69],"Migraine treatment","Zavegepant","NOT_YET_RECRUITING","2026-10-05",{"date":73,"type":74},"2026-10-06","ACTUAL",{"date":76,"type":61},"2026-09-30",{"date":78,"type":61},"2028-03-30",{"name":5,"class":6}]