PILOT-STUDY OF MK-462 IN MIGRAINE

MK-462 is a potent, selective 5HT(1D) receptor agonist which may be us eful in treating acute migraine. We conducted a double-blind placebo-c ontrolled inpatient study to assess the preliminary efficacy and safet y of oral doses of MK-462 20 mg (n=8) and 40 mg (n=36) vs placebo (n=2 1), administered to 65 male and post-menopausal female migraine patien ts aged 22-51 with moderate or severe migraine headache. Headache seve rity and functional disability were measured at 0.5, 1, 1.5, and 2 h p ost-dose. The 20 mg dose was well tolerated and 4/8 patients obtained relief in headache severity at the 2 h time point The 40 mg dose was w ell tolerated and was significantly (p<0.05) superior to placebo at th e 1.5 and 2 h time points (with 27/36 or 75% obtaining relief at 2 h c ompared to 7/21 or 33% for placebo). Adverse events occurred in 50% of patients on 20 mg MK-462, 72% of those on 40 mg MK-462, and in 52% of placebo-treated subjects. The most common adverse events associated w ith MK-462 were drowsiness (20 mg 12%; 40 mg 44%; placebo 24%), dry mo uth (40 mg 36%; placebo 19%), and lightheadedness/dizziness (40 mg 17% ; placebo 10%). Based on these preliminary results, MK-462 appears wor thy of continued study for the treatment of acute migraine.