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Naratriptan as Short-Term Prophylaxis of Menstrually Associated Migraine: A Randomized, Double-Blind, Placebo-Controlled Study


  • A complete list of the investigators who partipated in this study appears at the end of this article.

  • Presented in part at the 42nd Annual Scientific Meeting of the American Headache Society, Montreal, Quebec, June 23-25, 2000 and the 52nd Annual Meeting of the American Academy of Neurology, San Diego, Calif, April 29-May 6, 2000.

Address all correspondence to Dr. Lawrence Newman, St. Luke's-Roosevelt Hospital Center, Headache Institute, 1000 10th Avenue, Room 1C-10, New York, NY 10019.


Objective.—To determine the efficacy of naratriptan 1-mg and 2.5-mg tablets twice daily compared with placebo as short-term prophylaxis of menstrually associated migraine.

Background.—Approximately 60% of women with migraine report headaches associated with their menstrual cycles. Results from an open-label study suggest that short-term administration of sumatriptan is useful in the prophylaxis of menstrually associated migraine.

Methods.—A randomized, double-blind, three-arm, parallel-group, placebo-controlled study was conducted in women aged 18 years or older with a history of migraine with or without aura, as defined by the International Headache Society, of at least 6 months. Two dose strengths of naratriptan (1 mg, 2.5 mg) or identical-appearing placebo tablets (1:1:1) were administered twice daily for 5 days starting 2 days prior to the expected onset of menses across four perimenstrual periods. End points included the number of menstrually associated migraines, total migraine days, peak headache severity, lost work/activity time, migraine-related quality of life, and incidence of adverse events.

Results.—Overall, the intent-to-treat population comprised 206 women (naratriptan 1 mg, n = 70; naratriptan 2.5 mg, n = 70, and placebo, n = 66); 171 women treated four perimenstrual periods. Significantly more perimenstrual periods per subject treated with naratriptan, 1 mg, were headache-free compared with placebo (50% versus 25%, P = .003). Naratriptan, 1 mg, significantly reduced the number of menstrually associated migraines (2.0 versus 4.0, P < .05) and menstrually associated migraine days (4.2 versus 7.0, P  <  .01) compared with placebo. More patients treated with naratriptan, 1 mg, were headache-free across all treated perimenstrual periods compared with placebo (23% versus 8%). No difference in headache severity was observed in breakthrough headaches. The incidence and severity of adverse events was similar across treatment groups. Naratriptan, 2.5 mg, was not statistically superior to placebo for any measure.

Conclusions.—Naratriptan, 1 mg, with tolerability similar to placebo, is an effective, short-term, prophylactic treatment for menstrually associated migraine.