Methods	Multicentre, randomised, double-blind, placebo-controlled, parallel-group. Single dose to treat single attack Medication administered within 1 h of awakening with moderate or severe migraine pain, provided the pain continued to be moderate or severe by the time of dosing Assessments at 10, 20, 30, 60, and 120 minutes after dosing. Second dose of study medication, up to 100 mg of oral sumatriptan, or alternative rescue medication (usual migraine therapy) was available after 2 h if relief from initial dose was inadequate
Participants	Aged 18 to 65 years, meeting IHS criteria for migraine (1988) with or without aura. At least 1-year history of migraine with 1 to 6 attacks per month, and awakening with at least 1 moderate or severe migraine during the 3 months preceding screening Participants were excluded if they experienced tension-type headache on 15 or more days per month in any of the 3 months before screening Participants had to have successfully treated a migraine attack in the past with a 5-HT agonist, although participants must not have used a subcutaneous formulation of a 5-HT1 agonist previously N = 288 (287 for efficacy) M 38, F 249 (87%) Mean age 39 years Proportion with/without aura not reported
Interventions	Sumatriptan 6 mg, n = 149 (148 for efficacy) Placebo, n = 139
Outcomes	Headache relief (at 1 and 2 h) Pain-free (at 1 and 2 h) 24-hour sustained pain-free Presence of nausea, vomiting, photophobia, and phonophobia (at 1 and 2 h) Presence of functional disability (at 1 and 2 h) Adverse events Withdrawals
Notes	Oxford Quality Score: R1, DB1, W1. Total = 3.
Risk of bias
Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not reported
Study size	Unclear risk	Treatment groups 50 to 200 participants