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Randomized controlled trial of the orexin receptor antagonist filorexant for migraine prophylaxis
Almira Chabi1, Ying Zhang1, Saheeda Jackson1
1Merck & Co. Inc., Whitehouse Station, NJ, USA.
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.
Insights
Orexin receptor antagonist filorexant did not prove effective for migraine prevention in a pilot trial. The drug showed no significant difference from placebo in reducing migraine or headache days and was associated with more adverse events like somnolence.
Area of Science:
- Neurology
- Pharmacology
Background:
- Migraine is a complex neurological disorder impacting millions globally.
- Orexin receptors are implicated in pain pathways, suggesting a potential therapeutic target for migraine.
Purpose of the Study:
- To investigate the efficacy of orexin receptor antagonism for migraine prophylaxis.
- To evaluate the safety and tolerability of filorexant in migraine patients.
Main Methods:
- A randomized, double-blind, placebo-controlled pilot trial was conducted.
- Patients received either 10 mg nightly of filorexant or placebo for three months.
- Efficacy measured by monthly migraine and headache days; safety by adverse events.
Main Results:
- No statistically significant difference in mean monthly migraine or headache days between filorexant and placebo groups.
- Filorexant was generally well-tolerated but had a higher incidence of adverse events, notably somnolence (13% vs 4%).
Conclusions:
- Filorexant, at 10 mg nightly, did not demonstrate efficacy for migraine prophylaxis in this pilot study.
- Further research into orexin receptor antagonism for migraine may require different targets or dosing strategies.
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