TY - JOUR
T1 - Randomized controlled trial of the orexin receptor antagonist filorexant for migraine prophylaxis
AU - Chabi, Almira
AU - Zhang, Ying
AU - Jackson, Saheeda
AU - Cady, Roger
AU - Lines, Christopher
AU - Herring, W. Joseph
AU - Connor, Kathryn M.
AU - Michelson, David
PY - 2015/4/16
Y1 - 2015/4/16
N2 - 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.
AB - 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.
KW - Filorexant
KW - migraine
KW - MK-6096
KW - orexin
KW - prophylaxis
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U2 - 10.1177/0333102414544979
DO - 10.1177/0333102414544979
M3 - Article
C2 - 25106663
AN - SCOPUS:84924765911
SN - 0333-1024
VL - 35
SP - 379
EP - 388
JO - Cephalalgia
JF - Cephalalgia
IS - 5
ER -