Home > Neurology > AAN 2023 > Atogepant helps prevent treatment-resistant episodic migraine

Atogepant helps prevent treatment-resistant episodic migraine

Presented By
Dr Patricia Pozo-Rosich, University Hospital Vall d'Hebron, Spain
Conference
AAN 2023
Trial
Phase 3, ELEVATE

In the randomised, double-blind, placebo-controlled ELEVATE trial, atogepant 60 mg once daily was effective in preventing difficult-to-treat episodic migraine (EM) 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). The ELEVATE trial (NCT04740827) tested atogepant in treatment-refractory European and North-American participants [1], who had 4 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 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 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 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% versus 9.6%), nausea (7.1% versus 3.2%), and nasopharyngitis (5.1% versus 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. Session ES2.007, AAN 2023 Annual Meeting, 22–27 April, Boston, USA.

 

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