OBJECTIVE: To compare the efficacy and safety of subcutaneous sumatriptan with placebo in the treatment of menstrual migraine. METHODS: A double-blind, placebo-controlled, parallel group study was conducted to assess the efficacy and safety of subcutaneous sumatriptan in the treatment of menstrual migraine over two attacks. A total of 179 subjects receivedsumatriptan or placebo to treat at least one menstrual migraine attack. RESULTS: The efficacy results were consistent for attacks one and two. Two hours after treatment in attacks one and two, 53 (73%) and 51 (81%) of the sumatriptan-treated subjects, respectively, reported headache relief (reduction of a severe or moderately severe headache to a mild or no headache), compared with 27 (31%) and 18 (29%) of the placebo-treated subjects (P < .001). Within 24 hours of treatment in attack one, 28 (53%) and 14 (52%) of the initial responders to sumatriptan and placebo, respectively, experienced headache recurrence. The incidence and nature of adverse events in this study were similar to that seen in previous studies. CONCLUSIONS:Subcutaneous sumatriptan is an effective and well-tolerated acute treatment for menstrual migraine.
RCT Entities:
OBJECTIVE: To compare the efficacy and safety of subcutaneous sumatriptan with placebo in the treatment of menstrual migraine. METHODS: A double-blind, placebo-controlled, parallel group study was conducted to assess the efficacy and safety of subcutaneous sumatriptan in the treatment of menstrual migraine over two attacks. A total of 179 subjects received sumatriptan or placebo to treat at least one menstrual migraine attack. RESULTS: The efficacy results were consistent for attacks one and two. Two hours after treatment in attacks one and two, 53 (73%) and 51 (81%) of the sumatriptan-treated subjects, respectively, reported headache relief (reduction of a severe or moderately severe headache to a mild or no headache), compared with 27 (31%) and 18 (29%) of the placebo-treated subjects (P < .001). Within 24 hours of treatment in attack one, 28 (53%) and 14 (52%) of the initial responders to sumatriptan and placebo, respectively, experienced headache recurrence. The incidence and nature of adverse events in this study were similar to that seen in previous studies. CONCLUSIONS: Subcutaneous sumatriptan is an effective and well-tolerated acute treatment for menstrual migraine.