Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine
- Sponsor
- Pfizer
- Study ID
- NCT04574362
- Phase
- PHASE3
- Status
- Completed
Conditions
- Acute Migraine
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rimegepant — DRUGOne 75mg orally disintegrating tablet
- Placebo — DRUGMatching placebo
Study Details
This trial is to determine whether BHV3000 (rimegepant) 75mg is safe and effictive as a treatment for acute migraine in Chinese and Korean patients
Key Dates
- Start date
- Oct 22, 2020
- Status verified
- Mar 2023
- Primary completion
- Nov 24, 2021
- Completion
- Dec 16, 2021
Study Design
- Enrollment
- 1,648 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Rimegepant 75mgOne 75mg oral disintegration tablet
- Placebo Comparator: PlaceboMatching placebo
Primary Outcome Measure
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-dose [ Time Frame: 2 hours post-dose ]