This cross-over, double blind, randomized, multicentre study evaluated the
consistency of efficacy and safety of oral sumatriptan in 233 migraneurs. T
he patients received 50 mg oral sumatriptan or placebo for the treatment of
12 migraine attacks. Within each group of 4 attacks, three were treated wi
th sumatriptan and one with placebo, according to a randomization list. Ove
r all the attacks, the efficacy rate was statistically significant for suma
triptan against placebo at 2 or 4 hours (2 hours: sumatriptan 60%, PLO 38%,
p<0.001; 4 hours sumatriptan 79%, PLO 47%, p<0.001). Oral sumatriptan was
similarly effective at relieving the associated symptoms and at reducing cl
inical disability in most attacks. The incidence of adverse events did not
differ between treatment groups. All the events recorded were mild to moder
ate as intensity and resolved spontaneously.