ArticleNeurology and therapy2026
Atogepant for the Preventive Treatment of Migraine in Japanese Participants: A Phase 3, Open-Label, 52-Week Extension Study.
Article in Neurology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04437433 (A Phase 3, Multicenter, Open-Label 52-Week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine), which is not on this map. Not yet cited in PubMed.
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A Phase 3, Multicenter, Open-Label 52-Week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine
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11 authors.
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Abstract
introductionAtogepant is an oral calcitonin gene-related peptide receptor antagonist approved in the USA, EU, and Japan for the preventive treatment of migraine in adults. We evaluated the long-term safety, efficacy, and functional outcomes of atogepant for the preventive treatment of migraine in Japanese participants.
methodsThis open-label, 52-week, long-term safety extension study evaluated atogepant 60 mg once daily for the preventive treatment of migraine in Japanese participants. The study enrolled participants with chronic migraine (CM) who completed the phase 3 PROGRESS trial and de novo participants with episodic migraine (EM). The primary objective was the safety and tolerability of atogepant. Efficacy and functional outcomes were exploratory endpoints.
resultsOf 204 Japanese participants screened, 186 were enrolled and included in the safety population (CM, n = 155; EM, n = 31) and 180 in the modified intent-to-treat population (CM, n = 150; EM, n = 30). Treatment-emergent adverse events (TEAEs) occurred in 88.7% of participants. TEAEs occurring ≥ 10% were pyrexia (29.0%), nasopharyngitis (16.1%), and constipation (11.3%). Concurrent COVID-19 vaccination attributed to several TEAEs, including pyrexia. Serious TEAEs occurred in 3.8% of participants and none were considered related to atogepant by the investigator. TEAEs leading to discontinuation occurred in 4.8% of participants. Alanine aminotransferase and/or aspartate aminotransferase ≥ 3 × the upper limit of normal occurred in 4.8% of participants; none met criteria for Hy's law. The least squares mean change from baseline in monthly migraine days was - 6.4 days in PROGRESS CM completers and - 3.4 days in de novo EM participants at weeks 1-4 and was consistent over 52 weeks. Similar improvements were observed for the other efficacy and functional outcomes.
conclusionThe safety profile of atogepant in Japanese participants was consistent with the known safety profile in the global population. No new safety signals were identified. Improvements in efficacy and functional outcomes persisted over 52 weeks.
trial registrationNCT04437433; https://clinicaltrials.gov/study/NCT04437433.
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