Dose finding, placebo-controlled study of oral almotriptan in the acute treatment of migraine

Objective: To assess the efficacy and tolerability of oral almotriptan, a s elective serotonin receptor (5-HT1B/1D) agonist, when used at different dos es in the treatment of acute migraine. Methods: This was a placebo controll ed, double-blind, parallel-group, dose-finding study. Patients satisfying I nternational Headache Society criteria for acute migraine were randomized t o a single dose of placebo or oral almotriptan 2, 6.25, 12.5, or 25 mg at t he onset of moderate or severe pain. Patients graded pain intensity on a 4- point verbal scale from 0 (no pain) to 3 (severe pain) and recorded adverse events. The primary efficacy variable was headache response at 2 hours. Da ta were analyzed on an intent-to-treat basis. Results: Nine hundred and thr ee patients were randomized, and 742 were included in the evaluation of the efficacy and tolerability. Headache response at 2 hours was 32.5% with pla cebo, and 30%, 56.3%, 58.5%, and 66.5% with almotriptan 2, 6.25, 12.5, and 25 mg doses (p < 0.05 for 6.25, 12.5, and 25 mg vs placebo). A dose-depende nt decrease in the incidence of migraine-associated symptoms and the need f or escape medication was observed. The incidence of adverse events with the almotriptan 2-mg, 6.25-mg, and 12.5-mg groups was comparable to that with the placebo group. Conclusion: Almotriptan 12.5 mg demonstrated the most fa vorable ratio between efficacy and tolerability, offering equivalent effica cy and better tolerability compared with the 25 mg dose. The minimum effect ive dose of almotriptan was 6.25 mg.