A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
- Conditions
- Menstrual Migraine
- Interventions
- Registration Number
- NCT06641466
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 723
- Participant has regular menstrual cycles ≥24 days and ≤34 days
- 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
- A history of menstrual migraine attacks of at least 3 months
- 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.
- 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
- Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening
- 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
- History of retinal migraine, basilar migraine or hemiplegic migraine
- Current diagnosis of schizophrenia, bipolar, or borderline personality disorder
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing Rimegepant - Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing Rimegepant - Placebo Placebo Comparator - Standard of Care Standard of Care -
- Primary Outcome Measures
Name Time Method 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 5 months (5 menstrual cycles) Change from Observation Period in the number of migraine days per the 5-day perimenstrual period
- Secondary Outcome Measures
Name Time Method 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 5 months (5 menstrual cycles) Change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period
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 5 months (5 menstrual cycles) Change from the Observation Period in number of headache days per 5-day perimenstrual period
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) 5 months (5 menstrual cycles) Patients with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period
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 5 months (5 menstrual cycles) Change from the Observation Period in number of acute migraine specific medication days per 5-day perimenstrual period
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 5 months (5 menstrual cycles) Change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period
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 5 months (5 menstrual cycles) Change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period
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 5 months (5 menstrual cycles) Change from the Observation Phase in number of moderate-severe migraine days per 5-day perimenstrual period
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 5 months (5 menstrual cycles) Change from baseline in the MiCOAS Cognition score at post-dosing across each cycle
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 5 months (5 menstrual cycles) Change from the Observation Phase in monthly migraine days
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 5 months (5 menstrual cycles) Change from the Observation Phase in monthly headache days
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 5 months (5 menstrual cycles) Change from the Observation Phase in monthly acute migraine-specific medication days
Trial Locations
- Locations (24)
Tanaka Neurosurgery&Headache Clinic
🇯🇵Kagoshima, Japan
Sendai Headache and Neurology Clinic
🇯🇵Sendai, Miyagi, Japan
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Alliance for Multispecialty Research - Medisphere Medical Research Center
🇺🇸Evansville, Indiana, United States
Carolina Women's Research and Wellness Center
🇺🇸Durham, North Carolina, United States
Clinical Research of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Centricity Research Halifax Multispecialty
🇨🇦Halifax, Nova Scotia, Canada
Aggarwal and Associates Limited
🇨🇦Brampton, Ontario, Canada
Tatsuoka Neurology Clinic
🇯🇵Kyoto-shi Shimogyo-ku, Kyoto, Japan
Tokyo Headache Clinic
🇯🇵Shibuya-ku, Tokyo, Japan
Nagaseki Headache Clinic
🇯🇵Kai, Yamanashi, Japan
Tanaka Neurosurgical Clinic
🇯🇵Kagoshima, Japan
Velocity Clinical Research, Hallandale Beach
🇺🇸Hallandale Beach, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Urban Family Practice Associates
🇺🇸Marietta, Georgia, United States
McGill Family Practice
🇺🇸Papillion, Nebraska, United States
Excel Clinical Research, LLC
🇺🇸Las Vegas, Nevada, United States
Hope Clinical Research, Inc.
🇺🇸Canoga Park, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
VIN-Julie Schwartzbard
🇺🇸Aventura, Florida, United States
Michigan Headache & Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
St. Charles Clinical Research
🇺🇸Weldon Spring, Missouri, United States
Rochester Clinical Research, LLC
🇺🇸Rochester, New York, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States