In ELEVATE, atogepant was effective in preventing difficult-to-treat episodic migraine among patients with previous failure of multiple preventive medications.
Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant). The randomized, double-blind, placebo-controlled ELEVATE trial tested atogepant in treatment-refractory European and North American participants who had four to 14 monthly migraine days (MMDs). Overall, 56% of participants had failed two classes of oral preventive medication classes, and 44% had failed three or more. Participants were randomized 1:1 to daily treatment with atogepant 60 mg or placebo. The primary endpoint was the change from baseline in mean MMDs over 12 weeks.
The efficacy analysis population consisted of 309 participants, 154 (50%) of whom were in the atogepant group. After 12 weeks, the decrease in MMD in the atogepant group was significantly larger (mean, -4.20 days) than in the placebo group (-1.85 days; P<0.0001). Patients also experienced significant improvements on all secondary endpoints with atogepant versus placebo, including a 50% or greater reduction in MMDs, change in mean monthly headache days, and change in acute migraine drug use days over 12 weeks. The 50% responder rate was 50.6% with atogepant and 18.0% with placebo.
There were no new safety signals. The most common treatment-emergent adverse event (TEAEs) was constipation, which occurred in 10.3% of the atogepant group and 2.5% in the placebo group. The three other most common TEAEs were COVID-19 (8.3% vs 9.6%), nausea (7.1% vs 3.2%), and nasopharyngitis (5.1% vs 7.6%).
A limitation of the study was its short 12-week timeframe. However, longer duration poses a general (ethical) problem for migraine trials. The long-term efficacy and safety of prophylactic atogepant is yet to be determined.
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