• Almira Chabi, Ying Zhang, Saheeda Jackson, Roger Cady, Christopher Lines, W Joseph Herring, Kathryn M Connor, and David Michelson.
• Merck & Co. Inc., Whitehouse Station, NJ, USA.
• Cephalalgia. 2015 Apr 1; 35 (5): 379-88.

BackgroundThis study explored whether antagonism of orexin receptors might be an effective mechanism for migraine prevention.MethodsWe conducted a randomized, double-blind, placebo-controlled, pilot trial. Patients experiencing four to 14 days with migraine during a one-month baseline period were randomized to the orexin receptor antagonist filorexant 10 mg nightly or placebo for three months. Efficacy was assessed by mean monthly migraine days (headache plus at least one associated migraine symptom) and headache days. Safety and tolerability were assessed by adverse event reports and laboratory tests.ResultsOf 120 patients treated with filorexant and 115 treated with placebo, 97 (81%) and 101 (88%), respectively, completed the trial. There was no statistically significant difference between treatments for change from baseline in mean monthly migraine days (filorexant = -1.7, placebo = -1.3, difference = -0.4 (95% CI: -1.3, 0.4)) or headache days (filorexant = -1.7, placebo = -1.2, difference = -0.5 (95% CI: -1.4, 0.4)). Filorexant was generally well tolerated but was associated with a higher proportion of patients who reported adverse events than placebo (47% vs 37%), particularly somnolence (13% vs 4%).ConclusionsThese data fail to provide evidence that antagonism of orexin receptors with filorexant, when administered at night, is effective for migraine prophylaxis.© International Headache Society 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

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