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Objective This randomized, double-blind (DB) phase 3 trial evaluated rimegepant for preventive treatment of migraine in participants living in Japan.Methods Participants took rimegepant 75 mg or placebo every other day (EOD) during a 12-week DB phase, followed by rimegepant 75 mg EOD and up to once daily as needed on non-scheduled dosing days during a 40-week open-label phase. Hierarchical testing was used for efficacy endpoints to control for multiplicity. Safety assessments included adverse events and laboratory test abnormalities. DB phase data are presented.Results 484 (efficacy) and 496 (safety) treated participants were evaluable. During a 28-day pre-treatment observation period (OP), participants reported a mean±SD of 9.3±3.08 (rimegepant) and 9.0±3.14 (placebo) MMDs. The primary endpoint was met 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 rimegepant vs placebo (difference –1.1 [95% CI –1.73, –0.38], p=0.0021). Given the first secondary endpoint was not statistically significant, formal hypothesis testing did not proceed, but results for secondary efficacy endpoints favoured rimegepant vs placebo. Rimegepant was well tolerated.Conclusions Rimegepant 75 mg EOD demonstrated efficacy superior to placebo for migraine prevention with a favourable safety profile.grant.oneil@pfizer.com