Sumatriptan--an oral dose-defining study. The Oral Sumatriptan Dose-Defining Study Group

Three oral doses of sumatriptan, 100, 200 and 300 mg, given as dispersible tablets, were compared in the acute treatment of migraine in a double-blind, placebo-controlled, parallel-group study of 1,130 patients from 51 centres in eight countries. Patients treated up to three migraine attacks at home over a 3-month period and recorded the results on a diary card. Safety follow-ups were performed monthly at a clinic. All doses of sumatriptan were significantly (p less than 0.001) more effective than placebo at relieving headache within 2 h of treatment. Response rates, scored on a 4-point scale, were: placebo 27%; 100 mg sumatriptan 67%; 200 mg sumatriptan 73%; and 300 mg sumatriptan 67%. The proportion of patients who required rescue medication within 2 h of treatment was significantly (p less than 0.001) lower in all active treatment groups when compared with placebo. Response rates to sumatriptan were the same irrespective of the type of migraine (with or without aura) or the duration of symptoms prior to treatment (less than or equal to 4 or greater than 4 h). Sumatriptan also provided significant (p less than 0.001) relief from nausea and photophobia as compared with placebo. The majority of adverse events reported were mild to moderate in severity and were transient. The overall incidence of adverse events was dose-related, the percentage of patients reporting adverse events in the first attack treated being 36, 47 and 53% for 100-, 200- and 300-mg doses of sumatriptan, respectively, compared to 17% of placebo patients (p less than 0.001 for each treatment dose compared with placebo.(ABSTRACT TRUNCATED AT 250 WORDS)