NCT05399485

Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 496 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Rimegepant	Randomization Phase: Rimegepant (BHV3000) 75 mg orally disintegrating tablet every other day until Week 12
DRUG	Placebo	Randomization Phase: Placebo tablet to match Rimegepant every other day until Week 12

Timeline

• Start date: 2022-08-09
• Primary completion: 2024-01-18
• Completion: 2024-11-07
• First posted: 2022-06-01
• Last updated: 2025-11-18
• Results posted: 2025-07-14

Locations

44 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study