Abstract
Objectives Evaluate the time course of efficacy of atogepant for the preventive treatment of Chronic Migraine (CM).
Methods PROGRESS was a phase 3 trial which assessed the efficacy and safety of atogepant in patients with CM. This analysis evaluated the change from baseline in mean monthly migraine days (MMDs) during 4-week intervals, change in weekly migraine days during weeks 1–4, and the proportion of participants with a migraine on each day during the first 7 days of treatment.
Results 755 participants were included. Baseline MMDs ranged from 18.6 to 19.2. During weeks 1–4 of treatment,mean changes in MMDs were −6.6 for atogepant 30mg BID, −6.2 for atogepant 60mg QD, and −3.7 for placebo (P<0.001). This decrease was maintained during weeks 5–8 (P<0.001). Baseline mean weekly migraine days ranged from 4.6 to 4.8. During each week of the 1–4 weeks, mean reductions in weekly migraine days were greater in both atogepant groups compared with placebo (P≤0.009). During the baseline period, daily rates of participants reporting a migraine day ranged from 66.3% to 68.4%. On the first day after treatment initiation, atogepant participants were less likely to have a migraine than placebo (P≤0.03). TEAEs were reported by 56.4–63.2% participants taking atogepant, compared with 49.4% participants taking placebo. The most common TEAEs for atogepant were constipation (10.0–10.9%) and nausea (7.8–9.6%).
Conclusion Atogepant demonstrated early and sustained reduction in migraine days. Results showed a statistically significant effect as early as the first full day after study drug initiation. Atogepant was safe and well tolerated.
