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Almotriptan 12.5 mg in menstrually related migraine: a randomized, double-blind, placebo-controlled study.

Author(s): Allais G, Bussone G, D'Andrea G, Moschiano F, d'Onofrio F, Valguarnera F, Manzoni GC, Grazzi L, Allais R, Benedetto C, Acuto G

Affiliation(s): Women's Headache Center, Department of Gynecology and Obstetrics, University of Turin, Italy. gb.allais@tiscali.it

Publication date & source: 2011-01, Cephalalgia., 31(2):144-51. Epub 2010 Jul 26.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: Menstrually related migraine (MRM) affects more than half of female migraineurs. Because such migraines are often predictable, they provide a suitable target for treatment in the mild pain phase. The present study was designed to provide prospective data on the efficacy of almotriptan for treatment of MRM. METHODS: Premenopausal women with MRM were randomized to almotriptan (N = 74) or placebo (N = 73), taken at onset of the first perimenstrual migraine. Patients crossed over to the other treatment for the first perimenstrual migraine of their second cycle, followed by a two-month open-label almotriptan treatment period. RESULTS: Significantly more patients were pain-free at two hours (risk ratio [RR] = 1.81; p = .0008), pain-free from 2-24 hours with no rescue medication (RR = 1.99; p = .0022), and pain-free from 2-24 hours with no rescue medication or adverse events (RR = 1.94; p = .0061) with almotriptan versus placebo. Nausea (p = .0007) and photophobia (p = .0083) at two hours were significantly less frequent with almotriptan. Almotriptan efficacy was consistent between three attacks, with 56.2% of patients pain-free at two hours at least twice. Adverse events were similar with almotriptan and placebo. CONCLUSION: Almotriptan was significantly more effective than placebo in women with MRM attacks, with consistent efficacy in longer-term follow-up.

Page last updated: 2011-12-09

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