Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults

Summary

The purpose of this is study is to compare the efficacy of BHV-3000 (rimegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.

Timeline

Start

2018-11-14

Primary completion

2019-12-10

Completion

2021-02-02

Outcome

Met primary endpoint

paper Rimegepant was superior to placebo on the primary endpoint of change in the mean number of migraine days per month during weeks 9-12. PMID 33338437 ↗

paper least squares mean difference -0·8 days, 95% CI -1·46 to -0·20; p=0·0099 PMID 33338437 ↗

Publications

• Kudrow D, Croop RS, Thiry A, Lipton RB. A 52-week open-label extension study to evaluate the safety and efficacy of oral rimegepant for the preventive treatment of migraine. Headache. 2026 Feb;66(2):407-416. doi: 10.1111/head.15002. Epub 2025 Jun 30.
• Mahon R, Tiwari S, Koch M, Ferraris M, Betts KA, Wang Y, Gao S, Proot P. Comparative effectiveness of erenumab versus rimegepant for migraine prevention using matching-adjusted indirect comparison. J Comp Eff Res. 2024 Mar;13(3):e230122. doi: 10.57264/cer-2023-0122. Epub 2024 Jan 4.
• Powell LC, L'Italien G, Popoff E, Johnston K, O'Sullivan F, Harris L, Croop R, Coric V, Lipton RB. Health State Utility Mapping of Rimegepant for the Preventive Treatment of Migraine: Double-Blind Treatment Phase and Open Label Extension (BHV3000-305). Adv Ther. 2023 Feb;40(2):585-600. doi: 10.1007/s12325-022-02369-x. Epub 2022 Nov 22.
• Croop R, Lipton RB, Kudrow D, Stock DA, Kamen L, Conway CM, Stock EG, Coric V, Goadsby PJ. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021 Jan 2;397(10268):51-60. doi: 10.1016/S0140-6736(20)32544-7. Epub 2020 Dec 15.

Drugs

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

Indications