Atogepant effectively prevents episodic migraine: ELEVATE Study

The ELEVATE study found that atogepant (Qulipta) outperformed placebo for preventing migraines in patients with episodic migraine who were resistant to therapy.

Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) that was authorized in 2021 to prevent episodic migraine, an indication that was expanded this week to include chronic migraine prevention. CGRP, a powerful vasodilator peptide, is suspected to play a role in migraine.

In contrast to the injectable anti-CGRP monoclonal antibodies licensed for migraine prophylaxis in recent years (erenumab (Aimovig), galcanezumab (Emgality), fremanezumab (Ajovy), and eptinezumab (Vyepti), atogepant and other gepants are small-molecule medicines that can be taken orally.

This double-blind ELEVATE study, conducted by Pozo-Rosich P and colleagues, had 309 subjects from North America and Europe in its effectiveness analysis population; 154 were randomized to once-daily atogepant 60 mg and 155 to placebo. Participants had a minimum of one year of migraine history, with or without aura. During the study's 28-day screening phase, everyone had previously failed two to four oral migraine medicines and reported 4 to 14 monthly migraine days. Overall, 56% of individuals failed two classes of oral prophylactic medicines, with 44% failing three or more. The primary objective was the change in monthly migraine days from baseline to 12 weeks.