Trials / Recruiting
RecruitingNCT06641466
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 723 (estimated)
- Sponsor
- Pfizer · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rimegepant | Rimegepant 75 mg ODT for 7 days |
| DRUG | Placebo Comparator | Matching placebo oral disintegrating tablets for 7 days |
| DRUG | Standard of Care | Standard of care for acute treatment as needed |
| DRUG | Rimegepant | Rimegepant 75 mg ODT for acute treatment as needed |
Timeline
- Start date
- 2025-03-11
- Primary completion
- 2026-11-29
- Completion
- 2027-03-30
- First posted
- 2024-10-15
- Last updated
- 2026-04-16
Locations
122 sites across 15 countries: United States, Argentina, Canada, China, Denmark, Germany, India, Italy, Japan, Mexico, Netherlands, Poland, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06641466. Inclusion in this directory is not an endorsement.