311C90, A NEW CENTRAL AND PERIPHERALLY ACTING 5-HT1D RECEPTOR AGONISTIN THE ACUTE ORAL TREATMENT OF MIGRAINE - A DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGE FINDING STUDY

311C90 is a novel, centrally and peripherally, acting 5-hydroxytryptam ine(1D) receptor agonist. We investigated the efficacy and safety of 1 , 5, and 25 mg of oral 311C90 in the acute treatment of migraine in a randomized, double-blind, placebo-controlled, parallel-group clinical trial involving 84 patients. The proportion of patients in whom the he adache improved within 2 hours from moderate or severe to mild or no p ain (primary efficacy measure) was 15% for placebo-treated patients an d 27% (1 mg), 62% (5 mg), and 81% (25 mg) for patients treated with 31 1C90. Treatment differences compared with placebo were 12% (95% CI-12, 37; p = 0.460) for 1 mg 311C90, 47% (CI 21, 73; p < 0.005) for 5 mg 3 11C90, and 66% (CI 43, 89; p < 0.001) for 25 mg 311C90. Photophobia an d nausea also showed improvement after 311C90. Adverse events were gen erally mild and transient in all treatment groups. There were no clini cally significant changes in ECG recordings, blood pressure, or labora tory tests. Oral 311C90 (5 and 25 mg) is highly effective and well tol erated in the acute treatment of migraine. The response rates and trea tment differences compared with placebo in this study suggest possible superiority over existing antimigraine therapies. This needs to be co nfirmed in formal comparative trials.