At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 813 enrolled
Drug / intervention
Rimegepant +2 moredrug
Likely dose
Rimegepant 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
BHV3000-406 (C4951004): A Phase 4, Randomized, Double-blind Placebo-Controlled, Efficacy and Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
In Brief
A Phase 4 clinical trial evaluating Rimegepant and Placebo for Migraine. Completed, enrolled 813 participants across 93 sites in 15 countries.
Detailed Summary
This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesAustralia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Mexico, Poland, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2023202420252026
First PostedAug 2022
Enrollment StartOct 2022
Primary CompletionMar 2025
Study CompletionJun 2025
TodayJul 2026
First PostedAug 22, 2022
Enrollment StartOct 18, 2022
Primary CompletionMar 10, 2025
Study CompletionJun 10, 2025
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 3.9 years ago
Interventions
Rimegepantdrug
DB Phase: Rimegepant 75 mg Orally Disintegrating Tablet (ODT)
Placebodrug
DB Phase: matching placebo
Rimegepantdrug
OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines