Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)

Phase 3 Completed 897 enrolled Pfizer

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is being conducted to determine the appropriate dose of rimegepant in Japanese subjects, as well as to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the acute treatment of migraine.

Timeline

Start: 2022-08-09
Primary completion: 2024-01-19
Completion: 2024-01-19

Outcome

Met primary endpoint

registry analysis (superiority test); Rimegepant 75 mg vs Placebo; p <0.0001; Adjusted percentage difference 19.4 (95% CI 12.0 to 26.8); Mantel Haenszel NCT05399459 ↗

Publications

Ikeda K, Matsumori Y, Kudo M, Ishikawa T, Hoshino Y, Yoshimatsu H, Thiry A, Arakawa A, Croop R, Fullerton T, Sakai F, Takeshima T. Efficacy and safety of rimegepant for the acute treatment of migraine in Japan: A dose-ranging, double-blind, randomized controlled trial. Headache. 2025 Nov-Dec;65(10):1811-1820. doi: 10.1111/head.14994. Epub 2025 Jun 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rimegepant	Small molecule	25 mg	Oral
Subject	Rimegepant	Small molecule	75 mg	Oral