Long-term safety and effectiveness of rimegepant for the preventive treatment of migraine in Japan: an open-label extension of a phase 3 study
Abstract
BACKGROUND: The aim of the current analyses of a phase 3 randomized controlled trial conducted in Japan was to assess the long-term safety and effectiveness of rimegepant 75 mg, taken for up to 52 weeks, for the preventive treatment of migraine. METHODS: The study included adults in Japan with a history of 4–18 migraine attacks/month of moderate or severe pain intensity. After 12 weeks’ double-blind treatment with rimegepant 75 mg or placebo every other day, participants took open-label rimegepant 75 mg every other day and additionally as needed on nonscheduled dosing days (maximum one dose of rimegepant 75 mg per calendar day), for up to 40 weeks. Safety assessments included adverse events and hepatic function. Effectiveness endpoints included change in monthly migraine days, medication use, and changes in migraine-related quality of life and disability. RESULTS: Of 496 participants who received double-blind treatment, 458 participants were treated with rimegepant in the open-label-extension phase (mean age 43.9 years, 90.8% female) for a mean of 37.5 weeks. During the open-label extension phase, the most common adverse events were nasopharyngitis (25.1%) and COVID-19 (13.1%); the rate of adverse events leading to rimegepant discontinuation was 1.3% and the rate of serious adverse events was 0.9%. Aminotransferases >3x the upper limit of normal occurred in four (0.9%) participants during the open-label extension phase; none of these participants had concurrent elevations…
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: 496 participants or records.
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