Winner 2006.

Methods	Multicentre, randomised, double‐blind, placebo‐controlled, parallel‐group. Single dose to treat single attack. Medication administered to treat a morning migraine (defined as a headache of moderate or severe intensity on awakening) within 1 hour of awakening Assessments at 10, 20, 30, 60, and 120 minutes after dosing Second dose of study medication or alternative rescue medication available after 2 h for participants with inadequate relief or for those experiencing recurrence within 24 h 2 identically designed studies: Study 1 and Study 2
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 had awakened with moderate or severe migraine pain at least once in the 3 months preceding screening. No migraine prophylactic medication containing ergotamine, an ergot derivative, or methysergide, and no use of a monoamine oxidase inhibitor within 2 weeks before the studies. Participants were eligible for the studies only if they had previously treated a migraine successfully with a 5‐HT1B/1D agonist, but participants who had previously used subcutaneous sumatriptan were excluded No analgesics, antiemetics, or acute migraine medications from 6 h before through to 2 h after administration of study medication. No other 5‐HT agonists within 24 h before or after use of study medication, and no ergotamine or ergot‐type medications (including methysergide) for the duration of the studies Study 1 N = 299 (297 for efficacy) M 50, F 247 (83%) Mean age 41 years Without aura 61% Study 2 N = 288 (287 for efficacy) M 38, F 249 (87%) Mean age 39 years Without aura 73%
Interventions	Study 1 Sumatriptan 6 mg, n = 146 (145 for efficacy, 144 with moderate or severe baseline pain intensity) Placebo, n = 153 (152 for efficacy, 151 with moderate or severe baseline pain intensity) Study 2 Sumatriptan 6 mg, n = 149 (148 for efficacy) Placebo, n = 139
Outcomes	Headache relief (at 1 and 2 h) Pain‐free (at 2 h) 24 h sustained pain‐free Improvement in nausea, vomiting, photophobia, and phonophobia at 2 h Improvement in functional disability at 2 h Adverse events Withdrawals
Notes	Oxford Quality Score: R2, DB2, W1. Total = 5.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation schedule
Allocation concealment (selection bias)	Low risk	Remote allocation
Blinding (performance bias and detection bias) All outcomes	Low risk	Matching inactive vehicle injection in identical prefilled single‐dose syringe cartridges
Study size	Unclear risk	Treatment groups 50 to 200 participants

All medication delivered subcutaneously unless otherwise stated

AE: adverse event; DB: double‐blinding; DHE: dihydroergotamine; GP: general practitioner; h: hour; IHS: International Headache Society; NSAIDs: non‐steroidal anti‐inflammatory drugs; R: randomisation; W: withdrawals