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Efficacy and Tolerability of Naratriptan for Short-Term
Prevention of Menstrually Related Migraine: Data From
Two Randomized, Double-Blind, Placebo-Controlled Studies
Mannix LK, Savani N, Landy S, et al.
Posted: August 2007  
Headache 2007;47:1037-1049

Background:   In a pilot study, Naratriptan was significantly more effective than placebo in preventing menstrually related migraine (MRM) when given as 1 mg. twice daily for 5 days beginning 2 days before the predicted onset of MRM for up to 4 menstrual cycles.

Objective:   To evaluate the efficacy and tolerability of Naratriptan for short-term prevention of MRM in 2 large, identically designed, randomized, double-blind, placebo-controlled, parallel-group studies.

Methods:   MRM was defined as any migraine beginning during the perimenstrual period (PMP). By definition, the PMP consisted of Days -2, -1, 1, 2, 3 and 4, with Day 1 being the first day of menstrual flow. Adult women were eligible if they reported a history of MRM, had regular menstrual cycles, ad could predict within 2 days both the onset of menstrual flow and MRM. The studies comprised a baseline phase and a treatment phase. During the baseline phase, patients prophylactically treated their first PMP after the screening visit with single-blind placebo. Patients who documented an MRM while receiving placebo were eligible for the treatment phase. During the treatment phase, patients were randomized to receive either Naratriptan 1 mg. twice daily or placebo beginning 3 days before the predicted onset of MRM for a total of 6 days for 4 PMPs or 6 months, whichever occurred sooner. The primary efficacy endpoint was the mean percentage of treated PMPs without MRM per patient. Seconary efficacy endpoints included the percentage of patients who were free of MRM during all treated PMPs, the median number of days with MRM over 4 PMPs, and patient satisfaction. Safety and tolerability measures included adverse events, standard clinical laboratory tests, and vital signs.

Conclusions:   Naratriptan 1 mg. twice daily for 6 days per month is effective and well tolerated when used for short-term prevention of MRM. More patients receiving Naratriptan than placebo were satisfied with treatment. The observed increase in post-treatment attacks needs further study.