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
Pfizer
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.
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant has regular menstrual cycles ≥24 days and ≤34 days 2. 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 3. A history of menstrual migraine attacks of at least 3 months 4. 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. 5. If the participant is receiving a permitted background continuous prophylactic migraine medicat…
Interventions
- DrugRimegepant
Rimegepant 75 mg ODT for 7 days
- DrugPlacebo Comparator
Matching placebo oral disintegrating tablets for 7 days
- DrugStandard of Care
Standard of care for acute treatment as needed
- DrugRimegepant
Rimegepant 75 mg ODT for acute treatment as needed
Locations (122)
- Mayo Clinic HospitalPhoenix, Arizona
- Mayo Clinic Specialty BuildingPhoenix, Arizona
- Mayo Clinic ArizonaScottsdale, Arizona
- Hope Clinical Research, Inc.Canoga Park, California
- Axiom ResearchColton, California
- Diablo Clinical Research, Inc.Walnut Creek, California