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. 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. 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 with total bilirubin >2x upper limit of normal. For the open-label extension phase overall, monthly migraine days of any pain intensity reduced by a mean (95% confidence interval 95% CI) of –4.5 (95% CI –4.8, –4.2) days with 55.4% (95% CI 50.8, 59.9) of participants experiencing ≥50% reductions compared with the observation period. The use of acute treatments for migraine was low through the open-label extension phase. Improvements from baseline in Migraine-Specific Quality-of-Life Questionnaire v2.1, Migraine Disability Assessment (MIDAS), and EQ visual analog scale were observed through the 52-week study. Sustained effectiveness, with a favorable safety profile, was observed in treatment with rimegepant 75 mg taken up to once daily for up to 52 weeks. Trial registration Clinicaltrials.gov, NCT05399485. Registered May 27, 2022
Matsumori et al. (Fri,) studied this question.