This double-blind. randomized, placebo-controlled, parallel-group, multicenter study assessed the efficacy, acceptability, safety, and tolerability of subcutaneous sumatriptan 6 mg administered using a novel cartridge system self-injector for the acute treatment of migraine.
Eighty-six patients treated one migraine attack at home with sumatriptan or placebo. A second identical injection was available after 1 hour for inadequate relief or if the headache recurred. Rescue medication was available I hour later. The primary end point was headache relief (improvement in headache from moderate or severe to mild or no pain) within 60 minutes of the first injection. Secondary end points included the acceptability of the self-injector, requirement for and efficacy of a second dose, relief of nonheadache symptoms, use of rescue medication, and adverse events.
Significantly more patients taking sumatriptan than placebo reported headache relief I hour after the first injection (88% vs 11%, P <0.001). The device was well accepted by patients; about 90% found it easy to use and wanted to take further medication using it. Significantly fewer patients taking sumatriptan than placebo required a second injection (33% vs 92%, P <0.001) or rescue medication after the second injection (35% vs 67% P <0.05). Significantly more patients taking sumatriptan than placebo reported headache relief after the second injection (83% vs 32%, P <0.01), and resolution of non-headache migraine symptoms (54% vs 23%, P <0.01). Sumatriptan was generally well tolerated.
Subcutaneous sumatriptan 6 mg self-administered using the novel self-injector is an effective, well accepted, and well tolerated acute treatment of migraine.