Objective:

Evaluate the percent change in individual Activity Impairment in Migraine-Diary (AIM-D) item scores from baseline to Weeks 1-4 across three atogepant (Ato) trials.

Background:

ADVANCE, ELEVATE, and PROGRESS were phase 3, multicenter, randomized, double-blind, placebo (Pbo)-controlled, 12-week trials that included adults with episodic migraine (EM), EM with inadequate responses to 2-4 oral preventive treatments, and chronic migraine (CM), respectively. AIM-D is an 11-item daily measure that assesses migraine burden on the ability to perform daily activities and physical impairment. Item responses range from 0=“not difficult at all” to 5=“I could not do it at all”.

Design/Methods:

Post-hoc analyses evaluated the percent change from baseline mean score in each AIM-D item to Weeks 1-4 in participants taking Ato 60 mg once daily compared with Pbo. 

Results:

The modified intent-to-treat populations included: ADVANCE (Ato N=222; Pbo N=214); ELEVATE (Ato N=151; Pbo N=154); PROGRESS (Ato N=256; Pbo N=246). In ADVANCE, a greater percent change from baseline in all AIM-D items (46.9%-54.8%) was observed among Ato-treated participants compared with Pbo (17.2%-27.3%) at Week 1 (nominal P<0.05 in 10 of 11 items). In ELEVATE, a greater percent change from baseline in all AIM-D items (47.8%-57.7%) was observed among Ato-treated participants compared with Pbo (12.1%-20.2%) at Week 1 (nominal P<0.05 in all items). In PROGRESS, a greater percent change in all AIM-D items (31.0%-38.5%) was observed among Ato-treated participants compared with Pbo (13.8%-23.4%) at Week 1 (nominal P<0.05 in 10 of 11 items). Similar to Week 1, during Weeks 2-4 a greater percent change from baseline in all AIM-D items was found in Ato-treated participants.

Conclusions:

 As early as Week 1, a higher percent change from baseline in all AIM-D items was observed among Ato-treated participants compared with Pbo, demonstrating early improvements in function.