Atogepant reduces mean monthly migraine days compared with placebo

Key takeaways:

• A phase 3 study included adults with chronic migraine given atogepant or placebo daily for 12 weeks.
• Atogepant reduced mean monthly migraine days, showed favorable safety and tolerability.

Treatment with atogepant at 30 mg and 60 mg reduced mean monthly migraine days over 12 weeks compared with placebo, while showing good safety and tolerability profiles, according to research published in the Lancet Neurology.

“Chronic migraine is associated with substantial disease burden, including negatively impacting functioning, quality of life and health care resource use,” Patricia Pozo-Rosich, MD, PhD, director of the headache and neurological pair research group at Vall d’Hebron University Hospital in Barcelona, and colleagues wrote. “Gepants were specifically developed for migraine treatment and act as [calcitonin gene-related peptide] receptor agonists.”

Researchers sought to examine safety, efficacy and tolerability of atogepant as preventive treatment for those with chronic migraine in a phase 3 clinical trial conducted at 142 sites in 16 countries throughout Europe, North America and Asia.

Their randomized, double-blind, placebo-controlled PROGRESS study included 778 adults aged 18 to 80 years, with a 1 year or longer history of chronic migraine. Patients were randomized 1:1 to receive oral atogepant 30 mg twice a day (n = 257), oral atogepant 60 mg once a day (n = 262) or placebo (n = 259) for 12 weeks. The primary endpoint was alteration in mean monthly migraine days from baseline to end of treatment period for the modified intent to treat population, while the safety population consisted of all participants who received at least one dose of study intervention.

According to results, 84 participants discontinued treatment and 755 individuals remained in the modified intent to treat population.

Researchers found the changes in mean MMDs for the 12-week treatment period were 7.5 (SE 0.4) for atogepant 30 mg twice a day, 6.9 (0.4) with atogepant 60 mg once daily and 5.1 (0.4) for those given placebo. Least squares mean difference from placebo was 2.4 with atogepant 30 mg twice a day (95% CI 3.5 to 1.3; adjusted P < 0.0001) and 1.8 with atogepant 60 mg once a day (2.9 to 0.8; adjusted P = 0.0009).

The most common adverse events were constipation and nausea for the atogepant groups, while weight decrease was observed in all three treatment groups.

“The strong efficacy and well tolerated safety profile of atogepant for treating chronic migraine is potentially clinically important,” Pozo-Rosich and colleagues wrote.