Clinical Efficacy of Frovatriptan: Placebo-Controlled Studies.

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Bibliographic Details
Title:	Clinical Efficacy of Frovatriptan: Placebo-Controlled Studies.
Authors:	Ryan, R, Géraud, G, Goldstein, J, Cady, R, Keywood, C
Source:	Headache: The Journal of Head & Face Pain. Apr2002 Supplement 2, Vol. 42, p84-92. 9p.
Subjects:	Serotonin, Headache treatment, Migraine
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-HT1B 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 <= .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. [ABSTRACT FROM AUTHOR]
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Database:	Psychology and Behavioral Sciences Collection

Description
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-HT1B 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 <= .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. [ABSTRACT FROM AUTHOR]
ISSN:	00178748
DOI:	10.1046/j.1526-4610.42.s2.6.x