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The ADVANCE, ELEVATE, and PROGRESS studies were phase 3, randomized trials conducted over 12 weeks.
Atogepant (60 mg) significantly improves activity-related functioning as early as week 1 across episodic and chronic migraine populations.
The ADVANCE, ELEVATE, and PROGRESS studies were phase 3, randomized trials conducted over 12 weeks. These trials incorporated adults with episodic migraine (EM), EM with inadequate response to 2–4 previous oral preventive therapies, and chronic migraine (CM), respectively. This study was carried out to explore atogepant's impact on daily functioning in patients with episodic migraine and chronic migraine across these three trials.
In this post-hoc analysis, the percentage change from baseline in average scores for each Activity Impairment in Migraine-Diary (AIM-D) item at weeks 1–4 was calculated in participants receiving atogepant 60 mg once daily compared to those on placebo. Modified intent-to-treat sample sizes were: ADVANCE (Atogepant: n=222; Placebo: n=214), ELEVATE (Atogepant: n=151; Placebo: n=154), and PROGRESS (Atogepant: n=256; Placebo: n=246).
In week 1, subjects receiving atogepant in the ADVANCE trial exhibited greater percentage reductions in all AIM-D items (range: 46.9%–54.8%) when compared to placebo (17.2%–27.3%), with 10 of 11 items reaching nominal significance. Similarly, in ELEVATE, all AIM-D items improved more with atogepant (47.8%–57.7%) than placebo (12.1%–20.2%), with all differences nominally significant. In PROGRESS, atogepant yielded larger improvements across all items (31.0%–38.5%) than placebo (13.8%–23.4%), with nominal significance in 10 of 11 items. These improvements were sustained throughout weeks 2–4.
Atogepant treatment resulted in greater early functional improvements, as indicated by higher percentage reductions in AIM-D item scores as early as week 1, compared to placebo.
Neurology
Impact of Atogepant on Daily Functioning in Patients with Episodic Migraine and Chronic Migraine: Activity Impairment in Migraine-Diary (AIM-D) Item-Level Analysis (P12-12.004)
Richard B. Lipton et al.
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