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The phase 3b TEMPLE trial directly compared atogepant 60 mg once daily with the highest tolerated dose of topiramate (50–100 mg/day) for migraine prevention. Among 545 randomized participants, treatment discontinuation because of treatment-emergent adverse events was significantly lower with atogepant than topiramate (12.1% vs 29.6%; RR 0.41, 95% CI 0.28–0.59; P<0.0001). Overall adverse events occurred in 76.9% and 88.8% of participants, respectively, while treatment-related adverse events occurred in 56.0% versus 77.9%. Atogepant also demonstrated greater efficacy: 64.1% achieved at least a 50% reduction in mean monthly migraine days compared with 39.3% with topiramate (RR 1.63, 95% CI 1.37–1.95; P<0.0001). Mean monthly migraine days decreased by 6.27 days with atogepant versus 4.49 days with topiramate, representing a between-group difference of −1.78 days (95% CI −2.52 to −1.04; P<0.0001). No new safety signals were identified.
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The phase 3b TEMPLE trial directly compared atogepant 60 mg once daily with the highest tolerated dose of topiramate (50–100 mg/day) for migraine prevention. Among 545 randomized participants, treatment discontinuation because of treatment-emergent adverse events was significantly lower with atogepant than topiramate (12.1% vs 29.6%; RR 0.41, 95% CI 0.28–0.59; P<0.0001). Overall adverse events occurred in 76.9% and 88.8% of participants, respectively, while treatment-related adverse events occurred in 56.0% versus 77.9%. Atogepant also demonstrated greater efficacy: 64.1% achieved at least a 50% reduction in mean monthly migraine days compared with 39.3% with topiramate (RR 1.63, 95% CI 1.37–1.95; P<0.0001). Mean monthly migraine days decreased by 6.27 days with atogepant versus 4.49 days with topiramate, representing a between-group difference of −1.78 days (95% CI −2.52 to −1.04; P<0.0001). No new safety signals were identified.
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