Naratriptan as short-term prophylaxis of menstrually associated migraine: A randomized, double-blind, placebo-controlled study

Objective. - To determine the efficacy of naratriptan l-mg and 2.5-mg table ts twice daily compared with placebo as short-term prophylaxis of menstrual ly associated migraine. Background. - Approximately 60% of women with migraine report headaches ass ociated with their menstrual cycles. Results from an open-label study sugge st that short-term administration of sumatriptan is useful in the prophylax is of menstrually associated migraine. Methods - A randomized, double-blind, three-arm, parallel-group, placebo-co ntrolled 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 twic e daily for 5 days starting 2 days prior to the expected onset of menses ac ross four perimenstrual periods. End points included the number of menstrua lly associated migraines, total migraine days, peak headache severity, lost work/activity time, migraine-related quality of life, and incidence of adv erse events. Results. - Overall, the intent-to-treat population comprised 206 women (nar atriptan 1 mg, n = 70; naratriptan 2.5 mg, n = 70, and placebo, n = 66); 17 1 women treated four perimenstrual periods, Significantly more perimenstrua l periods per subject treated with naratriptan, 1 mg, were headache-free co mpared with placebo (50% versus 25%, P = .003). Naratriptan, 1 mg, signific antly 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 h eadache-free across all treated perimenstrual periods compared with placebo (23% versus 8%). No difference in headache severity was observed in breakt hrough headaches. The incidence and severity of adverse events was similar across treatment groups. Naratriptan, 2.5 mg, was not statistically superio r 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.