Once-daily atogepant reduced frequency of episodic migraine in adults

Key takeaways:

• ELEVATE study enrolled 309 adults who failed two to four previously prescribed classes of oral medications.
• Once daily 60 mg of atogepant significantly reduced monthly migraine days compared with placebo.

BOSTON – Treatment with once-daily atogepant significantly reduced monthly migraine days in adults with episodic migraine compared with placebo, according to preliminary data presented at the American Academy of Neurology annual meeting.

“People who thought they may not find a way to prevent and treat their migraines may have hope of finding relief with a tolerable oral, easy-to-use drug,” Patricia Pozo-Rosich, MD, PhD, study author and director of the headache and neurological pair research group at Vall d’Hebron University Hospital in Barcelona, stated in an AAN press release.

Researchers aimed to evaluate safety, efficacy and tolerability of 60 mg of once-daily atogepant – an oral calcitonin gene-related peptide receptor agonist – in those for whom two to four previously prescribed classes of medication failed to resolve episodic migraine.

They conducted the ELEVATE trial, a double-blind, placebo-controlled study held in Europe and North America, which included 309 adults (56% failed two classes of oral preventive medication; 44% failed three or more classes) who experienced migraine 4 to 14 days per month, randomized to receive either 60 mg of atogepant (n=154) or placebo (n=155) for 12 weeks. The primary endpoint was change in baseline in mean monthly migraine days across the entire trial, with secondary endpoints including change from baseline in acute medication use as well as reaching a reduction of 50% or more in monthly migraine days over 12 weeks.

According to results, those in the atogepant group registered a significantly greater decrease in monthly migraine days (-4.20 [0.39]) compared with those given placebo (1.85 [0.39]), with significant improvement demonstrated for all secondary endpoints in the atogepant group compared with the placebo group.

Data additionally showed that treatment-emergent adverse effects were mild to moderate but generally low for both the atogepant and placebo groups: constipation (10.3% vs. 2.5%), COVID-19 (8.3% vs. 9.6%), nausea (7.1% vs. 3.2%) and nasopharyngitis (5.1% vs. 7.6%).

“These results are exciting, as migraine can be debilitating, and this treatment led to fewer days with migraine for people who had already tried up to four other types of drugs to prevent migraine and either had no improvement or had side effects that outweighed any benefits,” Pozo-Rosich said.