Efficacy and safety of rimegepant for the acute treatment of migraine in Japan: A dose-ranging, double-blind, randomized controlled trial
Abstract
Objective: The objectives of this study were to compare the efficacy, including dose response, and safety of rimegepant, an orally administered small-molecule calcitonin gene-related peptide receptor antagonist, with placebo for the acute treatment of migraine in Japan.
Background: There is a substantial unmet need for the acute treatment of migraine in Japan due to undesirable attributes of existing acute treatments.
Methods: In this Phase 2/3, double-blind, randomized trial, adults with a ≥1-year history of migraine were recruited to 50 study centers in Japan. Participants were randomly assigned to receive rimegepant 25 mg, rimegepant 75 mg, or placebo and instructed to treat a single migraine attack of moderate or severe pain intensity. The randomization was stratified by preventive migraine medication use (yes or no). The primary endpoint was the proportion of participants with pain freedom at 2 h post-dose. Formal hypothesis testing was conducted for rimegepant 75 mg versus placebo. Safety was assessed based on adverse events (AEs).
Results: The study was conducted from August 9, 2022, through January 19, 2024. A total of 706 treated participants were evaluable for efficacy (rimegepant 25 mg, n = 238; rimegepant 75 mg, n = 238; placebo, n = 230) and safety (rimegepant 25 mg, n = 239; rimegepant 75 mg, n = 238; placebo, n = 229). Response rates for pain freedom at 2 h post-dose were 21.0% (rimegepant 25 mg), 32.4% (rimegepant 75 mg), and 13.0% (placebo): percentage…
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. Reported size: 706 participants or records.
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