Oral sumatriptan for the long-term treatment of migraine: clinical findings.

This double-blind, placebo-controlled, crossover study of the acute treatment of migraine investigated the efficacy and tolerability of oral sumatriptan 100 mg (Imitrex) administered for up to nine attacks compared with placebo administered for up to three attacks. Patients were randomized to receive oral sumatriptan 100 mg or placebo on an outpatient basis in a 3:1 ratio for three four-attack blocks. Headache relief 4 hours postdose was observed in 59 to 65% of patients after sumatriptan treatment compared with 18 to 23% of patients after placebo treatment across three four-attack blocks (p < 0.005). For each block, oral sumatriptan 100 mg was also significantly more effective than placebo at relieving clinical disability and nausea and vomiting. Efficacy on all these measures was consistently maintained with repeated administration. Oral sumatriptan 100 mg was well tolerated, and repeated administration did not alter the pattern or severity of adverse events. These data demonstrate that the efficacy and tolerability of oral sumatriptan 100 mg was consistently maintained with repeated administration for up to nine separate migraine attacks.