drugset / Trial / NCT03235479
Safety and Efficacy Study in Adult Subjects With Acute Migraines
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo in subjects with Acute Migraines
Timeline
- Start
- 2017-07-18
- Primary completion
- 2018-01-21
- Completion
- 2018-01-26
Outcome
Met primary endpoint
registry analysis (superiority test); Rimegepant 75 mg vs Placebo; p = 0.0298; Risk Difference (RD) 4.9 (95% CI 0.5 to 9.3) NCT03235479 ↗
registry analysis (superiority test); Rimegepant 75 mg vs Placebo; p = 0.0016; Risk Difference (RD) 8.9 (95% CI 3.4 to 14.4) NCT03235479 ↗
Publications
- Charleston L 4th, Armand CE, Monteith TS, O'Brien HL, Abbott CC, Pixton GC, Fullerton T. Efficacy and safety of rimegepant for the acute treatment of migraine in Black or African American adults: A post hoc pooled subgroup analysis from three randomized, placebo-controlled clinical trials. Headache. 2026 Apr;66(4):874-884. doi: 10.1111/head.70034. Epub 2026 Feb 6.
- Lipton RB, Thiry A, Morris BA, Croop R. Efficacy and Safety of Rimegepant 75 mg Oral Tablet, a CGRP Receptor Antagonist, for the Acute Treatment of Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pain Res. 2024 Jul 22;17:2431-2441. doi: 10.2147/JPR.S453806. eCollection 2024.
- Lipton RB, Blumenfeld A, Jensen CM, Croop R, Thiry A, L'Italien G, Morris BA, Coric V, Goadsby PJ. Efficacy of rimegepant for the acute treatment of migraine based on triptan treatment experience: Pooled results from three phase 3 randomized clinical trials. Cephalalgia. 2023 Feb;43(2):3331024221141686. doi: 10.1177/03331024221141686.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rimegepant | Small molecule | 75 mg | Oral |