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July 27, 2004; 63 (2) Articles

A randomized trial of frovatriptan for the intermittent prevention of menstrual migraine

Stephen D. Silberstein, Arthur H. Elkind, Curtis Schreiber, Charlotte Keywood
First published July 26, 2004, DOI: https://doi.org/10.1212/01.WNL.0000134620.30129.D6
Stephen D. Silberstein
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Arthur H. Elkind
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Curtis Schreiber
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Charlotte Keywood
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A randomized trial of frovatriptan for the intermittent prevention of menstrual migraine
Stephen D. Silberstein, Arthur H. Elkind, Curtis Schreiber, Charlotte Keywood
Neurology Jul 2004, 63 (2) 261-269; DOI: 10.1212/01.WNL.0000134620.30129.D6

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Abstract

Background: Menstrually associated migraine (MAM) is often prolonged and difficult to manage with conventional therapies. Frovatriptan is a new selective 5HT1B/1D receptor agonist indicated for short-term management of migraine. It has a long half-life and good tolerability. These characteristics suggest that frovatriptan may be useful for the intermittent prevention of MAM.

Methods: The study was a randomized, double-blind, placebo-controlled, three-way crossover design. Patients treated each of three perimenstrual periods (PMPs) with placebo, frovatriptan 2.5 mg QD, and frovatriptan 2.5 mg BID. The 6-day treatment started 2 days before the anticipated start of MAM headache. The primary efficacy endpoint was incidence of MAM headache during the 6-day PMP.

Results: The population comprised 546 women (mean age, 37.6 years). Use of frovatriptan reduced the occurrence of MAM headache. The incidence of MAM headache during the 6-day PMP was 67% for placebo, 52% for frovatriptan 2.5 mg QD, and 41% for frovatriptan 2.5 mg BID. Both frovatriptan regimens were superior to placebo (p < 0.0001), and the BID regimen was superior to the QD regimen (p < 0.001). Both frovatriptan regimens also reduced MAM severity (p < 0.0001), duration (p < 0.0001), and the use of rescue medication (p < 0.01 QD; p < 0.0001 BID) in a dose-dependent manner. The incidence and type of adverse events for both regimens were similar to placebo and consistent with those reported for short-term migraine management.

Conclusion: Frovatriptan given prophylactically for 6 days was effective in reducing the incidence of menstrually associated migraine. More than half of patients who used frovatriptan 2.5 mg BID had no menstrually associated migraine headache during the 6-day perimenstrual period. The findings are consistent with the long duration of action and good tolerability of frovatriptan observed in short-term migraine management.

  • Received April 18, 2003.
  • Accepted May 21, 2004.
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Disputes & Debates: Rapid online correspondence

  • A randomized trial of frovatriptan for the intermittent prevention of menstrual migraine
    • James U. Adelman, Headache Wellness Center, 301 E. Wendover Ave. Greensboro, NC 27401jadelman@triad.rr.com
    • Anne Calhoun
    Submitted October 28, 2004
  • Reply to Adelman et al
    • Stephen D. Silberstein, MD, Jefferson Headache Center, 111 S. 11th Street, 8130 Gibbon, Philadelphia, PA 19107stephen.silberstein@jefferson.edu
    Submitted October 28, 2004
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