Once-daily oral atogepant is effective for reducing the number of migraine days during a period of 12 weeks, according to a study published in the Aug. 19 issue of the New England Journal of Medicine.
Jessica Ailani, M.D., from the MedStar Georgetown University Hospital in Washington, D.C., and colleagues conducted a phase 3 trial involving adults with four to 14 migraine days per month. Participants were randomly assigned to receive a once-daily dose of oral atogepant (10, 30, or 60 mg) or placebo for 12 weeks (214, 223, 222, and 214 participants, respectively).
The researchers found that the changes from baseline in the mean number of migraine days per month across 12 weeks were −3.7, −3.9, −4.2, and −2.5 days with atogepant 10, 30, or 60 mg and placebo, respectively. The mean differences from placebo in the change from baseline were −1.2, −1.4, and −1.7 days with 10-, 30-, and 60-mg atogepant, respectively. For the secondary end points, results favored atogepant over placebo, except for the Activity Impairment in Migraine-Diary Performance of Daily Activities score and Physical Impairment score for the 10-mg dose. Constipation (6.9 to 7.7 percent across atogepant doses) and nausea (4.4 to 6.1 percent across atogepant doses) were the most common adverse events.
“Longer and larger trials are needed to determine the effect and safety of atogepant for migraine prevention,” the authors write.
The study was funded by Allergan, before acquisition by AbbVie, which now manufactures atogepant.