A randomized, double-blind, placebo-controlled trial of the efficacy and tolerability of a 4-mg dose of subcutaneous sumatriptan for the treatment of acute migraine attacks in adults

Abstract

Objective: The aim of this study was to evaluate the efficacy and tolerability of a single 4-mg dose of sumatriptan SC for the acute treatment of adult patients experiencing a migraine attack with moderate to severe pain. Methods: In this randomized, double-blind, placebo-controlled study, subjects included men and women aged 18 to 60 years who had migraine with or without aura, as defined by the 1988 International Headache Society criteria. Subjects received either sumatriptan 4 mg SC or placebo SC for a migraine attack with headache pain of moderate to severe intensity. The primary efficacy measurement was pain relief at 2 hours. Secondary efficacy measures included the severity of headache pain at 10, 20, 30, 40, 50, 60, and 90 minutes postadministration. Clinical assessments of pain severity and adverse events were made by way of questioning and observation of subjects and were completed at 10, 20, 30, 40, 50, 60, 90, and 120 minutes postadministration. Results: Five hundred seventy-seven subjects (87% female and 94% white) participated in this study. Three hundred eighty-four received sumatriptan and 193 received placebo. At 120 minutes postadministration, sumatriptan 4 mg SC was associated with greater proportions of patients who experienced pain relief (70% vs 22%; P < 0.001) or were pain free (50% vs 11%; P < 0.001). In addition, there were statistically significant differences between sumatriptan 4 mg SC and placebo for multiple secondary end points, including pain relief as early as 10 minutes postadministration (11% vs 6%; P = 0.039), pain-free status as early as 30 minutes postadministration (10% vs 3%; P < 0.001), nausea as early as 30 minutes postadministration (39% vs 49%; P = 0.021), and photophobia as early as 10 minutes postadministration (80% vs 87%; P = 0.046). The most common adverse events in the sumatriptan 4-mg SC and placebo groups, respectively, were injection-site reactions (43% and 15%), tingling (12% and 3%), dizziness or vertigo (10% and 5%), and warm or hot sensation (8% and 2%). Treatment groups were not statistically compared for adverse events. Conclusions: Sumatriptan 4 mg SC was effective for the acute treatment of migraine attacks and was generally well tolerated in these patients.