Evaluation of a multiple-dose regimen of oral sumatriptan for the acute treatment of migraine. The Oral Sumatriptan International Multiple-Dose Study Group.

In a multinational, placebo-controlled, double-blind, parallel-group study of oral sumatriptan (GR43175), given as a dispersible tablet, in the acute treatment of migraine, 149 patients were randomized to receive 100 mg sumatriptan and 84 to placebo. Each patient was provided with three tablets: one to be taken as soon as possible after headache onset; one to be taken 2 h later if the headache persisted and one to be taken if the headache recurred within 24 h. Patients recorded details of the attack and response to treatment on a diary card. Sumatriptan was significantly more effective than placebo in relieving headache (moderate/severe reduced to mild/none) at 2 h (50 vs. 19%; p less than 0.001) and at 4 h (75 vs. 30%; p less than 0.001). Of the sumatriptan group, 59% took the second dose compared with 80% of the placebo group (p less than 0.001). Compared with placebo, more patients on sumatriptan were pain-free by 2 h (26 vs. 5%; p less than 0.001) and by 4 h (48 vs. 13%; p less than 0.001). Headache improvement was apparent by 1 h in 42% of sumatriptan-treated patients and 17% of patients on placebo. Headache relief was significantly (p less than 0.001) better in patients taking sumatriptan, irrespective of the type of migraine (with or without aura), or the time the drug was taken (less than or more than 4 h after onset). There was no significant difference in the number of patients who took placebo or sumatriptan and whose headache recurred within 24 h of initial resolution (42 vs. 48%; p = 0.535).(ABSTRACT TRUNCATED AT 250 WORDS)