A randomised, double-blind, parallel-group, placebo-controlled trial w
as undertaken to assess the efficacy and tolerability of the sumatript
an suppository in 184 patients with acute migraine, Patients used a su
matriptan suppository (12.5 mg or 25 mg) or placebo at home for the tr
eatment of a moderate or severe migraine attack and those who experien
ced headache recurrence within 24 hours of dosing had the option to re
peat the dose, By 2 hours post-dose, 68% of patients in the sumatripta
n 25 mg group and 47% of patients in the sumatriptan 12.5 mg group com
pared with 25% of placebo patients achieved headache relief, Relief ra
tes 2 hours post-dose for nausea, vomiting, photophobia and phonophobi
a were similar to those reported 2 hours post-dose for headache. Post
hoc review of the recurrence data showed that administration of a seco
nd suppository was effective in alleviating recurrent headache in over
80% of the sumatriptan-treated patients experiencing recurrence, No s
erious or unusual adverse events were reported, and the pattern and in
cidence of adverse events did not vary as a function of dose. These da
ta demonstrate that the sumatriptan suppository is a well-tolerated, e
ffective treatment for the acute treatment of migraine pain and its as
sociated symptoms.