Atogepant for the Preventive Treatment of Chronic Migraine in Europe: Results From the PROGRESS Study

Abstract text (incl. figure legends and references)

Objective: Present the primary and key secondary endpoints for the Europe subpopulation in the PROGRESS trial.

Methods: Phase 3 multicenter, randomized, double-blind, placebo (PBO)-controlled trial (RCT) evaluated the efficacy and safety of atogepant (ATO) for prevention in people with chronic migraine (CM). Participants with ≥1-year CM history, ≥15 headache d/mo in the past 3 months, and ≥15 headache days (≥8 days qualified as migraine) during the 28-day screening period were randomized to receive ATO 30mg twice daily (BID), ATO 60mg once daily (QD), or PBO in the 12-week treatment period. In this analysis we examined a Europe subpopulation. Primary outcome was change from baseline in monthly migraine days (MMDs) across the 12-week treatment period, and the key secondary outcome was proportion of participants with ≥50% reduction in 3-month MMD average.

Results: From the safety population (n=773; female, 87.6%, mean age, 42.1y), 760 individuals were included in the off-treatment hypothetical estimand population and 269 were included in the Europe subpopulation (PBO n=88, ATO 30mg BID n=91, ATO 60mg QD n=90). Least square (LS) mean change in MMDs was −8.44 in the ATO 30mg BID and −8.00 ATO 60mg QD groups compared to −5.42 in the PBO group. LS mean difference [95% CI] vs PBO was greater in both groups (ATO 30mg BID: −3.02 [−4.82, −1.22]; ATO 60mg QD: −2.59 [−4.39, −0.79]). A higher proportion of ATO 30mg BID (48.4%; OR [95% CI]: 1.87 [1.01, 3.44]; nominal P=0.0457) and ATO 60mg QD (46.7%; OR [95% CI]: 1.84 [1.00, 3.41]; nominal P=0.0511) participants had a ≥50% reduction in 3-month average of MMDs compared to PBO (33.0%).

Conclusions: In the Europe subpopulation, both ATO doses demonstrated significantly higher reductions in mean MMDs and proportions of ≥50% responders in MMD reduction over 3 months vs PBO.