Frovatriptan for the acute treatment of migraine: a dose-finding study.

OBJECTIVE: To determine the optimal dose and tolerability of frovatriptan in the acute treatment of migraine.

BACKGROUND: Frovatriptan has a distinctive pharmacological and pharmacokinetic profile compared with sumatriptan. A previous study has shown that frovatriptan doses of 2.5, 5, 10, 20, and 40 mg are equally effective in relieving headache with no evidence of a dose-response relationship. The incidence of adverse events tended to increase with doses of 10 mg and above.

METHODS: This study was a randomized, double-blind, placebo-controlled, parallel-group multicenter trial. Patients (n=635) took a single oral dose of placebo or frovatriptan, 0.5, 1, 2.5, or 5 mg, at the onset of a moderate or severe migraine headache and recorded headache intensity, functional impairment, and migraine-associated symptoms over 24 hours.

RESULTS: Frovatriptan 2.5 mg produced clinically and statistically significant headache relief 2 hours post-dose, whereas the effect of lower doses was not significantly different from that of placebo at that time point. The 2.5-mg dose also produced significant symptom relief and improvement in functional impairment. All doses of frovatriptan were well tolerated, and the majority of adverse events were of mild or moderate severity.

CONCLUSION: It is concluded that the 2.5-mg dose of frovatriptan offers optimal efficacy and tolerability in the treatment of acute migraine. Higher doses do not appear to confer greater efficacy and are associated with an increased incidence of adverse effects.