drugset / Trial / NCT03461757
Trial in Adult Subjects With Acute Migraines
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) versus placebo in subjects with Acute Migraines.
Timeline
- Start
- 2018-02-27
- Primary completion
- 2018-10-08
- Completion
- 2018-10-15
Outcome
Met primary endpoint
registry analysis (superiority test); Rimegepant 75 mg ODT vs Placebo; p < 0.0001; Risk Difference (RD) 10.4 (95% CI 6.5 to 14.2) NCT03461757 ↗
registry analysis (superiority test); Rimegepant 75 mg ODT vs Placebo; p = 0.0009; Risk Difference (RD) 8.3 (95% CI 3.4 to 13.2) NCT03461757 ↗
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, 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.
- Johnston KM, Powell L, Popoff E, Harris L, Croop R, Coric V, L'Italien G. Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm. Clin J Pain. 2022 Nov 1;38(11):680-685. doi: 10.1097/AJP.0000000000001072.
- Croop R, Goadsby PJ, Stock DA, Conway CM, Forshaw M, Stock EG, Coric V, Lipton RB. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019 Aug 31;394(10200):737-745. doi: 10.1016/S0140-6736(19)31606-X. Epub 2019 Jul 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rimegepant | Small molecule | 75 mg | Other |