Trial reportThe journal of headache and pain2026
Long-term safety and effectiveness of rimegepant for the preventive treatment of migraine in Japan: an open-label extension of a phase 3 study.
Trial report in The journal of headache and pain, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05399485 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for Migraine Prevention in Japanese Subjects), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for Migraine Prevention in Japanese Subjects
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of rimegepant for acute and preventive treatment of migraine: a systematic review and meta-analysis of randomized controlled trials.BMC pharmacology & toxicology · 2026Pooled it
- Improvements in Patient-Reported Outcome Measures Through 64 Weeks' Rimegepant Treatment for Migraine: Analysis of a Randomized Controlled Trial with Open-Label Extension.Journal of pain research · 2026Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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.
methodsThe 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.
resultsOf 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.
conclusionsSustained 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 registrationTrial registration Clinicaltrials.gov, NCT05399485. Registered May 27, 2022
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