CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 496 enrolled
Drug / intervention
Rimegepant +1 moredrug
Likely dose
Rimegepant 75 mg orally disintegrating tablet every other dayAI-extracted
Key inclusion· 7
  • ✓Age of migraine onset prior to 50 years
  • ✓4 to 18 moderate or severe migraine attacks per month in the 3 months prior to screening
  • ✓At least 4 migraine days during the observation period
  • ✓No more than 18 total headache days during observation period
Key exclusion· 9
  • ✕History of migraine with brainstem aura (basilar), hemiplegic, or retinal migraine
  • ✕≥19 headache days per month (migraine or non-migraine) in any of the 3 months prior to screening
  • ✕Systemic analgesic use (NSAIDs or acetaminophen) ≥15 days per month in the 3 months prior to screening
  • ✕History of HIV disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05399485
NCT05399485Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for Migraine Prevention in Japanese Subjects

Pfizer·interventional·Posted Jun 1, 2022·Updated Nov 18, 2025

In Brief

A Phase 3 clinical trial evaluating Rimegepant and Placebo for Migraine. Completed, enrolled 496 participants across 44 sites.

Detailed Summary

This study is being conducted to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the prevention of migraine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedJun 1, 2022
Enrollment StartAug 9, 2022
Primary CompletionJan 18, 2024
Study CompletionNov 7, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.1 years ago

Interventions

Rimegepantdrug

Randomization Phase: Rimegepant (BHV3000) 75 mg orally disintegrating tablet every other day until Week 12

Placebodrug

Randomization Phase: Placebo tablet to match Rimegepant every other day until Week 12