Safety and Efficacy in Adult Subjects With Acute Migraines

Summary

The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo in subjects with Acute Migraines

Timeline

Start

2017-07-27

Primary completion

2018-01-25

Completion

2018-01-31

Outcome

Met primary endpoint

registry NUMBER Rimegepant 75 mg: 19.6 (16.2 to 22.9) Percentage of participants NCT03237845 ↗

registry Rimegepant 75 mg vs Placebo; p = 0.0006; Risk Difference (RD) 7.6 (95% CI 3.3 to 11.9) NCT03237845 ↗

registry NUMBER Rimegepant 75 mg: 37.6 (33.5 to 41.7) Percentage of Participants NCT03237845 ↗

registry Rimegepant 75 mg vs Placebo; p < 0.0001; Risk Difference (RD) 12.4 (95% CI 6.9 to 17.9) NCT03237845 ↗

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.
• Lipton RB, Croop R, Stock EG, Stock DA, Morris BA, Frost M, Dubowchik GM, Conway CM, Coric V, Goadsby PJ. Rimegepant, an Oral Calcitonin Gene-Related Peptide Receptor Antagonist, for Migraine. N Engl J Med. 2019 Jul 11;381(2):142-149. doi: 10.1056/NEJMoa1811090.

Drugs

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

Indications