Methods | 2-phase study Phase one: multicentre, randomised, double-blind, placebo-controlled, cross-over design. Single dose to treat each of 2 successive migraine attacks Medication administered when migraine headache pain was of moderate or severe intensity Assessments at 0.5, 1, 1.5, and 2 h after initial dosing Second dose of study medication (identical to first dose) available to treat recurrence between 2 and 24 h Rescue medication (except ergotamine) available if initial treatment not effective within 2h Phase 2: open-label phase |
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Participants | Aged 18 to 65 years, meeting IHS criteria for migraine (1988) with or without aura. History of 1 to 6 moderate or severe migraine attacks per month Participants were excluded if they had previous experience with subcutaneous sumatriptan No ergotamine in the 24-h period before taking study medication or within 6 h afterwards N = 118 treated ≥ 1 attack (108 treated both attacks) M 12, F 106 (90%) Mean age 43 years Proportion with/without aura not reported |
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Interventions | Sumatriptan 6 mg, n = 117 attacks Placebo, n = 109 attacks |
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Outcomes | Headache relief (at 1 and 2 h) Pain-free (at 1 h) Use of rescue medication Adverse events Withdrawals |
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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 | Number in each treatment arm for first attack not reported |