This randomized, double-blind, parallel-group, placebo-controlled stud
y evaluated the efficacy and tolerability of oral sumatriptan (Imitrex
tablets) in 259 migraineurs. In the clinic, patients received oral su
matriptan 25 mg, 50 mg, or 100 mg, or placebo for the treatment of a m
igraine attack. The results indicate that by 2 hours post-dose, 50 to
56% of patients treated with any of the three doses, compared with 26%
of patients treated with placebo, achieved relief of headache (p < 0.
05 for each sumatriptan group vs placebo). By 4 hours postdose, 68 to
71% of sumatriptan-treated patients, compared with 38% of placebo-trea
ted patients, achieved relief of headache (p < 0.05 for each sumatript
an group vs placebo). Oral sumatriptan was similarly effective at reli
eving nausea and photophobia and at reducing clinical disability. The
pattern and incidence of adverse events did not differ between treatme
nt groups. All doses - 25 mg, 50 mg, and 100 mg-of sumatriptan were ef
fective and generally well tolerated. Dosing should be individualized
according to the needs of the patient.