Atogepant helps prevent treatment-resistant episodic migraine

In the randomised, double-blind, placebo-controlled ELEVATE trial, atogepant 60 mg once daily effectively prevented difficult-to-treat episodic migraine in patients who had previously failed between 2 and 4 classes of oral preventive migraine medications. Atogepant was safe and well-tolerated.

Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) approved for treating episodic migraine and, in the USA, for the preventive treatment of migraine. The burden of migraine is higher in patients who have previously failed prophylactic treatment. The ELEVATE trial (NCT04740827) tested atogepant in treatment-refractory European and North-American participants who had 4 to 14 monthly migraine days (MMDs) [1]. Overall, 56% of participants had previously failed 2 classes of oral preventive medication classes, and 44% had failed 3 or more. Participants were randomised 1:1 to daily treatment with atogepant 60 mg or a placebo. The primary endpoint was the change from baseline in mean MMDs over 12 weeks.

The efficacy analysis population comprised 309 participants, with 154 (50%) 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 significantly improved 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% and 18.0%, respectively.

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 versus 2.5% in the placebo group. The 3 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 time frame. However, longer duration poses a general (ethical) problem for migraine trials. The long-term efficacy and safety of prophylactic atogepant are yet to be determined.

1. Pozo-Rosich P, et al. Atogepant for the preventive treatment of migraine among participants with episodic migraine with prior treatment failure: Results from the ELEVATE trial. ES2.007, AAN 2023 Annual Meeting, 22–27 April, Boston, USA.

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Posted on 26 June 2023