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Evaluation of Efficacy, Safety, and Tolerability of Atogepant for Preventive Treatment of Chronic Migraine

This study aimed to assess the effectiveness, safety, and tolerability of atogepant as a preventive treatment for chronic migraine. Conducted across multiple clinical research sites in various countries, the randomised, double-blind, placebo-controlled phase 3 trial involved adults aged 18-80 years with a history of chronic migraine lasting one year or more. Participants were assigned randomly to receive either oral atogepant 30 mg twice a day, oral atogepant 60 mg once a day, or placebo. The primary endpoint was the change in mean monthly migraine days (MMDs) over the 12-week treatment period. The primary analysis was conducted on the modified intent-to-treat population and included participants who received at least one dose of the study intervention and had baseline and post-baseline data. The safety population included all participants who received at least one dose of the study intervention. ClinicalTrials.gov registered this trial under the identifier NCT03855137.

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