Open Label Safety Study in Acute Treatment of Migraine

Summary

The purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant).

Timeline

Start

2017-08-30

Primary completion

2019-07-15

Completion

2019-07-15

Publications

• Ailani J, Pavlovic J, Pixton GC, Fullerton T. Rimegepant safety and patient-reported outcomes among triptan-naive, triptan-using, and triptan-failure participants: Subgroup analysis of an open-label, multicenter study. Cephalalgia. 2025 Jul;45(7):3331024251343309. doi: 10.1177/03331024251343309. Epub 2025 Jul 9.
• Kudrow D, Hutchinson S, Pixton GC, Fullerton T. Safety of Rimegepant in Adults with Migraine and Anxiety, Depression, or Using Antidepressants: Analysis of a Multicenter, Long-Term, Open-Label Study. Pain Ther. 2025 Feb;14(1):237-255. doi: 10.1007/s40122-024-00675-6. Epub 2024 Nov 9.
• True D, Mullin K, Croop R. Safety of Rimegepant in Adults with Migraine and Cardiovascular Risk Factors: Analysis of a Multicenter, Long-Term, Open-Label Study. Pain Ther. 2024 Oct;13(5):1203-1218. doi: 10.1007/s40122-024-00626-1. Epub 2024 Jul 10.
• Fullerton T, Pixton G. Long-Term Use of Rimegepant 75 mg for the Acute Treatment of Migraine is Associated with a Reduction in the Utilization of Select Analgesics and Antiemetics. J Pain Res. 2024 May 15;17:1751-1760. doi: 10.2147/JPR.S456006. eCollection 2024.
• Croop R, Berman G, Kudrow D, Mullin K, Thiry A, Lovegren M, L'Italien G, Lipton RB. A multicenter, open-label long-term safety study of rimegepant for the acute treatment of migraine. Cephalalgia. 2024 Apr;44(4):3331024241232944. doi: 10.1177/03331024241232944.
• Johnston K, Harris L, Powell L, Popoff E, Coric V, L'Italien G, Schreiber CP. Monthly migraine days, tablet utilization, and quality of life associated with Rimegepant - post hoc results from an open label safety study (BHV3000-201). J Headache Pain. 2022 Jan 17;23(1):10. doi: 10.1186/s10194-021-01378-5.
• Johnston KM, L'Italien G, Popoff E, Powell L, Croop R, Thiry A, Harris L, Coric V, Lipton RB. Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant. Adv Ther. 2021 Oct;38(10):5209-5220. doi: 10.1007/s12325-021-01897-2. Epub 2021 Aug 29.
• Mullin K, Kudrow D, Croop R, Lovegren M, Conway CM, Coric V, Lipton RB. Potential for treatment benefit of small molecule CGRP receptor antagonist plus monoclonal antibody in migraine therapy. Neurology. 2020 May 19;94(20):e2121-e2125. doi: 10.1212/WNL.0000000000008944. Epub 2020 Jan 13.

Drugs

Indications