Randomized controlled trial of the orexin receptor antagonist filorexant for migraine prophylaxis

Almira Chabi, Ying Zhang, Saheeda Jackson, Roger Cady, Christopher Lines, W. Joseph Herring, Kathryn M. Connor, David Michelson

Research output: Contribution to journalArticlepeer-review

53 Scopus citations


Background: This study explored whether antagonism of orexin receptors might be an effective mechanism for migraine prevention. Methods:We 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. Results: Of 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%). Conclusions: These data fail to provide evidence that antagonism of orexin receptors with filorexant, when administered at night, is effective for migraine prophylaxis.

Original languageEnglish (US)
Pages (from-to)379-388
Number of pages10
Issue number5
StatePublished - Apr 16 2015
Externally publishedYes


  • Filorexant
  • migraine
  • MK-6096
  • orexin
  • prophylaxis

ASJC Scopus subject areas

  • Clinical Neurology
  • Medicine(all)


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