Efficacy and safety of rimegepant for the preventive treatment of migraine in Japan: A double-blind, randomized controlled trial
Abstract
Objectives/background: This study was undertaken to compare the efficacy of the oral calcitonin gene-related peptide receptor antagonist rimegepant relative to placebo as a preventive treatment for migraine in Japan. This was the first randomized placebo-controlled trial of rimegepant for the preventive treatment of migraine to be conducted outside the United States and the second conducted globally.
Methods: In this phase 3, double-blind, randomized, multicenter trial, conducted August 9, 2022 through January 18, 2024, adults in Japan with a history of 4-18 migraine attacks/month of moderate or severe pain intensity completed a 28-day observation phase and then took rimegepant 75 mg or placebo every other day during the 12-week double-blind treatment phase. The primary endpoint was the mean change from the observation phase in the number of monthly migraine days in the last 4 weeks of the double-blind treatment phase. Safety was assessed based on the frequency of adverse events and laboratory test abnormalities during the double-blind treatment phase.
Results: A total of 484 (efficacy) and 496 (safety) treated participants were evaluable. During the observation phase, participants in the rimegepant and placebo groups, respectively, reported a mean (SD) of 9.3 (3.1) and 9.0 (3.1) monthly migraine days. The study met its primary endpoint with a statistically significant difference in mean change from the observation phase in the number of monthly migraine days in the last 4…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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