In a phase 3 trial conducted at 142 clinical research sites in 16 countries, 778 adults with a 1-year or more history of chronic migraine responded to atogepant 30 mg twice a day or 60 mg once a day, researchers report, compared with placebo. “Both atogepant doses were well tolerated, consistent with the known safety profile of atogepant,” the authors conclude.
Based on a primary endpoint of a change from baseline in mean monthly migraine days (MMDs) across the 12-week treatment period, the investigators found: “Baseline mean number of MMDs were 18.6 (SE 5.1) with atogepant 30 mg twice a day, 19.2 (5.3) with atogepant 60 mg once a day, and 18.9 (4.8) with placebo. Change from baseline in mean MMDs across 12 weeks was −7.5 (SE 0.4) with atogepant 30 mg twice a day, −6.9 (0.4) with atogepant 60 mg once a day, and −5.1 (0.4) with placebo. Least squares mean difference from placebo was −2.4 with atogepant 30 mg twice a day (95% CI −3.5 to −1.3; adjusted P <0.0001) and −1.8 with atogepant 60 mg once a day (−2.9 to −0.8; adjusted P = 0.0009). Most common adverse events for atogepant were constipation (30 mg twice a day 28 [10.9%]; 60 mg once a day 26 [10%]; and placebo 8 [3%]) and nausea (30 mg twice a day 20 [8%]; 60 mg once a day 25 [10%]; and placebo 9 [4%]). Potentially clinically significant weight decrease (≥7% reduction at any time post-baseline) was observed in each treatment group (atogepant 30 mg twice a day 14 [6%]; atogepant 60 mg once a day 15 [6%]; and placebo 5 [2%]).”