Yasuhiko Matsumori1, Shigekazu Kitamura2, Toshimasa Yamamoto3, Tomofumi Ishikawa4, Yuko Hoshino4, Hiroki Yoshimatsu4, Alexandra Thiry5, Akio Arakawa4, Robert Croop6, Terence Fullerton5, Fumihiko Sakai7, Takao Takeshima8
1Sendai Headache and Neurology Clinic, Sendai-shi, Miyagi, Japan, 2Department of Neurology, Konan Medical Center, Kobe-shi, Hyogo, Japan, 3Department of Neurology, Saitama Medical University, Iruma-gun, Saitama, Japan, 4Pfizer R&D Japan, Shibuya-ku, Tokyo, Japan, 5Pfizer, Groton, CT, USA, 6Biohaven Pharmaceuticals, New Haven, CT, USA, 7Saitama International Headache Center, Saitama Neuropsychiatric Institute, Saitama-shi, Saitama, Japan, 8Headache Center, Department of Neurology, Tominaga Hospital, Osaka-shi, Osaka, Japan
Objective:
The primary objective was to compare the efficacy of rimegepant (RIM) with placebo (PBO) for the preventive treatment of migraine in participants living in Japan.
Background:
This phase 3 trial (NCT05399485) was a double-blind (DB), randomized, multicenter evaluation of the efficacy and safety of RIM orally disintegrating tablet compared with PBO for the preventive treatment of migraine in participants living in Japan.
Design/Methods:
Adults with a history of 4–18 migraine attacks/month of moderate or severe pain intensity completed a 28-day observation phase (OP), then took RIM 75 mg or PBO every other day (EOD) during the 12-week DB phase, followed by RIM 75 mg EOD and up to once daily as needed on nonscheduled dosing days during the 40-week open-label phase. Hierarchical testing was used for efficacy and outcomes research endpoints to control for multiplicity. The primary endpoint was mean change from OP in the number of monthly migraine days (MMDs) in the last 4 weeks of the DB phase. Safety was assessed based on adverse events (AEs) and laboratory test abnormalities. Data are presented for the DB phase.
Results:
A total of 484 (efficacy) and 496 (safety) treated participants were evaluable. During the OP, participants reported a mean ± SD of 9.3 ± 3.08 (RIM) and 9.0 ± 3.14 (PBO) MMDs. The study met its primary endpoint with a statistically significant difference in mean change from OP in the number of MMDs in the last 4 weeks of the DB phase for RIM vs PBO (difference –1.1 [95% CI –1.73, –0.38], p=0.0021). Results for secondary efficacy endpoints numerically favored RIM vs PBO. RIM was well tolerated during the DB phase. There were no Hy’s law cases.
Conclusions:
RIM 75 mg EOD demonstrated efficacy superior to PBO for migraine prevention with a favorable safety profile. Funded by Pfizer.
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