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

Cephalalgia. 2011 Jan;31(2):144-51. doi: 10.1177/0333102410378048. Epub 2010 Jul 26.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 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*
  • Serotonin Receptor Agonists / adverse effects
  • Treatment Outcome
  • Tryptamines / administration & dosage*
  • Tryptamines / adverse effects
  • Young Adult

Substances

  • Placebos
  • Serotonin Receptor Agonists
  • Tryptamines
  • almotriptan