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, Cephalalgia. , 31(2):144-51
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.
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