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  • Title: Clinical efficacy of frovatriptan: placebo-controlled studies.
    Author: Ryan R, Géraud G, Goldstein J, Cady R, Keywood C.
    Journal: Headache; 2002 Apr; 42 Suppl 2():S84-92. PubMed ID: 12028324.
    Abstract:
    OBJECTIVE: To confirm the clinical efficacy of frovatriptan 2.5 mg. BACKGROUND: Frovatriptan is a new 5-hydroxytryptamine (5-HT)(1B/1D) receptor agonist being developed for the acute treatment of migraine with or without aura. Results from preclinical and clinical pharmacology studies showed frovatriptan to be a potent 5-HT(1B) receptor agonist with a long terminal elimination half-life (26 hours) and a broad therapeutic index. DESIGN: Three randomized, placebo-controlled, double-blind, parallel-group trials, in a total of 2676 patients, were performed to confirm the clinical efficacy of frovatriptan 2.5 mg for the acute treatment of migraine. RESULTS: In all three studies, headache response 2 hours after frovatriptan dosing was significantly greater than that seen with placebo (P < or = .001) with approximately a two-fold measure of effect over placebo for headache response at 2 and 4 hours postdosing. Time to headache response occurred within 1.5 hours in a substantial proportion of patients. The incidence of 24-hour headache recurrence with frovatriptan was low (10% to 25%). Frovatriptan therapy also was associated with a high degree of patient satisfaction. CONCLUSIONS: Frovatriptan represents a consistently effective acute treatment for migraine and accompanying symptoms.
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