Lanepitant, an NK-1 antagonist, in migraine prevention

Lanepitant, a potent non-peptide neurokinin-l receptor antagonist, inhibits neurogenic dural inflammation, and may have a role in migraine therapy. Th is study evaluated the effect of lanepitant taken daily for migraine preven tion. Patients with migraine headaches with and without aura by Internation al Headache Society classification criteria were enrolled in a 12-week doub le-blind, parallel design study comparing the effect of 200 mg qd lanepitan t (n =42) and placebo (n =42) on reduction of migraine frequency. The prima ry outcome measure was response rate, i.e. the proportion of patients with a 50% reduction in days of headache. Of the 84 patients enrolled, 90.5% wer e female. The endpoint response rate for lanepitant-treated patients (41.0% ) was not statistically significantly (P=0.065) greater than that for place bo-treated patients (22.0%). No efficacy variables differed significantly b etween treatments, except for response rates at month 3 (P=0.045). Higher p lasma concentrations were no more effective than lower concentrations. In t his study lanepitant was not effective in preventing migraine, but was well tolerated. These results do not support a role for NK-1 antagonism in migr aine prevention.