Oral zolmitriptan in the short-term prevention of menstrual migraine: a randomized, placebo-controlled study.

OBJECTIVE: To evaluate the efficacy and tolerability of oral zolmitriptan as a short-term preventative therapy for menstrual migraine. METHODS: This was a randomized, double-blind, parallel group, placebo-controlled, multicentre, two-phase study. The results of the second phase are reported here (the first phase evaluated zolmitriptan in the acute treatment of menstrual migraine and is reported elsewhere). Women who successfully completed phase I (with either a positive or negative outcome, and who still fulfilled the inclusion criteria) were randomized to zolmitriptan 2.5 mg oral tablet three times daily, zolmitriptan 2.5 mg twice daily or placebo three times daily. Patients were treated for three consecutive menstrual cycles, starting 2 days prior to the expected onset of menses, for 7 days in total. RESULTS: Two hundred and fifty-three patients completed phase I and were eligible for phase II. The intention-to-treat population comprised 244 patients (zolmitriptan three times daily [n = 83]; zolmitriptan twice daily [n = 80]; placebo [n = 81]). Both zolmitriptan regimens demonstrated superior efficacy versus placebo, as measured by the proportion of patients with a >or=50% reduction in the frequency of menstrual migraine attacks (zolmitriptan three times daily [58.6%], p = 0.0007 vs placebo; zolmitriptan twice daily [54.7%], p = 0.002 vs placebo; placebo three times daily [37.8%]). The mean frequency of breakthrough migraine attacks per menstrual cycle was reduced accordingly. Fewer breakthrough attacks were treated with escape medication in the zolmitriptan three times daily (61.6% of attacks; p = 0.0004 vs placebo) and twice daily (60.7%; p = 0.0055 vs placebo) treatment groups than in the placebo group (74.4%). Short-term preventative therapy with zolmitriptan was well tolerated. CONCLUSION: Zolmitriptan 2.5 mg oral tablet is effective and well tolerated as a short-term preventative therapy for menstrual migraine attacks.