Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
Study NCT ID:
NCT06641466
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2024-10-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
Sponsor:
Organization:
Raw JSON
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'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2024-10-11', 'studyFirstSubmitQcDate': '2024-10-11', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase', 'timeFrame': '5 months (5 menstrual cycles)', 'description': 'Change from Observation Period in the number of migraine days per the 5-day perimenstrual period'}], 'secondaryOutcomes': [{'measure': 'Mean change from the Observation Period in number of headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase', 'timeFrame': '5 months (5 menstrual cycles)', 'description': 'Change from the Observation Period in number of headache days per 5-day perimenstrual period'}, {'measure': 'Percentage of participants with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase (50% responder)', 'timeFrame': '5 months (5 menstrual cycles)', 'description': 'Patients with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period'}, {'measure': 'Mean change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase', 'timeFrame': '5 months (5 menstrual cycles)', 'description': 'Change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period'}, {'measure': 'Mean change from the Observation Period in number of acute migraine-specific medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase', 'timeFrame': '5 months (5 menstrual cycles)', 'description': 'Change from the Observation Period in number of acute migraine specific medication days per 5-day perimenstrual period'}, {'measure': 'Mean change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase', 'timeFrame': '5 months (5 menstrual cycles)', 'description': 'Change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period'}, {'measure': 'Mean change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase', 'timeFrame': '5 months (5 menstrual cycles)', 'description': 'Change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period'}, {'measure': 'Mean change from the Observation Period in number of moderate-severe migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase', 'timeFrame': '5 months (5 menstrual cycles)', 'description': 'Change from the Observation Phase in number of moderate-severe migraine days per 5-day perimenstrual period'}, {'measure': 'Mean change from baseline in the MiCOAS Cognition score at postdosing (ie, 1 day after the 7-day dosing period) across each cycle of the Double-Blind Treatment Phase', 'timeFrame': '5 months (5 menstrual cycles)', 'description': 'Change from baseline in the MiCOAS Cognition score at post-dosing across each cycle'}, {'measure': 'Mean change from the Observation Period in monthly migraine days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase', 'timeFrame': '5 months (5 menstrual cycles)', 'description': 'Change from the Observation Phase in monthly migraine days'}, {'measure': 'Mean change from the Observation Period in monthly headache days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase', 'timeFrame': '5 months (5 menstrual cycles)', 'description': 'Change from the Observation Phase in monthly headache days'}, {'measure': 'Mean change from the Observation Phase in monthly acute migraine-specific medication days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase', 'timeFrame': '5 months (5 menstrual cycles)', 'description': 'Change from the Observation Phase in monthly acute migraine-specific medication days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menstrual Migraine']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4951063', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant has regular menstrual cycles ≥24 days and ≤34 days\n2. A minimum 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition\n3. A history of menstrual migraine attacks of at least 3 months\n4. Participant reported history of experiencing at least 1 migraine attack during the perimenstrual period in at least 2 out of 3 menstrual cycles immediately prior to screening.\n5. If the participant is receiving a permitted background continuous prophylactic migraine medication, the medication dose must be stable for at least 3 months prior to the Screening visit and, the dose is not expected to change during the course of the study\n\nExclusion Criteria:\n\n1. Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening\n2. A diagnosis of chronic migraine or a history of more than 14 headache days per month on average, in the 3 months prior to Screening\n3. History of retinal migraine, basilar migraine or hemiplegic migraine\n4. Current diagnosis of schizophrenia, bipolar, or borderline personality disorder\n5. Other pain syndromes (eg, fibromyalgia, complex regional pain syndrome), or significant neurological disorders (other than migraine), or other medical conditions (including endocrine and gynecological eg, severe dysmenorrhea'}, 'identificationModule': {'nctId': 'NCT06641466', 'briefTitle': 'A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, PARALLEL GROUP STUDY TO INVESTIGATE INTERMITTENT PREVENTION OF MENSTRUAL MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN WOMEN PARTICIPANTS 18 TO 45 YEARS OF AGE', 'orgStudyIdInfo': {'id': 'C4951063'}, 'secondaryIdInfos': [{'id': 'NCT06641466', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing', 'interventionNames': ['Drug: Rimegepant']}, {'type': 'EXPERIMENTAL', 'label': 'Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing', 'interventionNames': ['Drug: Rimegepant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo Comparator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'interventionNames': ['Drug: Standard of Care']}], 'interventions': [{'name': 'Rimegepant', 'type': 'DRUG', 'description': 'Rimegepant 75 mg ODT for 7 days', 'armGroupLabels': ['Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing']}, {'name': 'Placebo Comparator', 'type': 'DRUG', 'description': 'Matching placebo oral disintegrating tablets for 7 days', 'armGroupLabels': ['Placebo']}, {'name': 'Standard of Care', 'type': 'DRUG', 'description': 'Standard of care for acute treatment as needed', 'armGroupLabels': ['Standard of Care']}, {'name': 'Rimegepant', 'type': 'DRUG', 'description': 'Rimegepant 75 mg ODT for acute treatment as needed', 'armGroupLabels': ['Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic Specialty Building', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91303', 'city': 'Canoga Park', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Hope Clinical Research, Inc.', 'geoPoint': {'lat': 34.20112, 'lon': -118.59814}}, {'zip': '92324', 'city': 'Colton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Axiom Research', 'geoPoint': {'lat': 34.0739, 'lon': -117.31365}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'VIN - 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