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

Abstract

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.

• Authors: Gianni Allais, Gennaro Bussone, Giovanni D'Andrea, Franca Moschiano, Florindo d'Onofrio, Fabio Valguarnera, Gian Camillo Manzoni, Licia Grazzi, Rita Allais, Chiara Benedetto, Giancarlo Acuto
• Journal: Cephalalgia : an international journal of headache (Cephalalgia) Vol. 31 Issue 2 Pg. 144-51 (Jan 2011) ISSN: 1468-2982 [Electronic] England
• PMID: 20660540 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Placebos
• Serotonin Receptor Agonists
• Tryptamines
• almotriptan

Topics

• Adolescent
• Adult
• Animals
• Cross-Over Studies
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Menstruation Disturbances (drug therapy)
• Middle Aged
• Migraine Disorders (drug therapy)
• Placebos
• Prospective Studies
• Serotonin Receptor Agonists (administration & dosage, adverse effects)
• Treatment Outcome
• Tryptamines (administration & dosage, adverse effects)
• Young Adult