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.
The key findings of this study were:
1. Constipation (10.3% for atogepant vs. 2.5% for placebo), nausea (7.1% vs 3.2%), COVID-19 (8.3% vs. 9.6%), and nasopharyngitis (5.1% vs 7.6%) were the most often reported treatment-emergent side effects.
2. Compared to placebo, episodic migraine patients who had previously failed oral preventive therapy experienced a substantially larger decrease in monthly migraine days with once-daily atogepant 60 mg (-4.20 days) after 12 weeks.
People who thought there was no way to prevent and manage migraines may find relief with a pleasant, oral, easy-to-use medication. For those suffering from difficult-to-treat migraines, this medication was safe, well-tolerated, and effective.
Reference:
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" AAN 2023