drugset / Trial / NCT05399485
Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study is being conducted to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the prevention of migraine.
Timeline
- Start
- 2022-08-09
- Primary completion
- 2024-01-18
- Completion
- 2024-11-07
Outcome
Met primary endpoint
paper The study met its primary endpoint with a statistically significant difference PMID 40542538 ↗
paper difference rimegepant vs. placebo: -1.1 [95% confidence interval = -1.73 to -0.38], p = 0.002 PMID 40542538 ↗
Publications
- Matsumori Y, Kitamura S, Yamamoto T, Ishikawa T, Hoshino Y, Yoshimatsu H, Thiry A, Arakawa A, Fullerton T, Sakai F, Takeshima T. Long-term safety and effectiveness of rimegepant for the preventive treatment of migraine in Japan: an open-label extension of a phase 3 study. J Headache Pain. 2026 Feb 27;27(1):66. doi: 10.1186/s10194-026-02290-6.
- Kitamura S, Matsumori Y, Yamamoto T, 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 preventive treatment of migraine in Japan: A double-blind, randomized controlled trial. Headache. 2025 Sep;65(8):1403-1412. doi: 10.1111/head.14995. Epub 2025 Jun 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rimegepant | Small molecule | 75 mg | Oral |