Methods | Multicentre, randomised, double-blind, placebo-controlled, parallel-group. Single dose to treat single attack Medication administered at onset of migraine aura Assessments at 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h after dosing Second unblinded dose of sumatriptan 6 mg available after 2 h for inadequate relief Rescue medication available 2 h after second dose of study medication |
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Participants | Aged 18 to 65 years, meeting IHS criteria for migraine (1988) with aura. At least 6-month history of migraine (untreated severity ≥ moderate) and at least 50% of attacks with aura Excluded participants with previous use of subcutaneous sumatriptan N = 177 (171 for efficacy, 82 with moderate or severe baseline pain intensity) M 46, F 125 (73%) Mean age 40 years All treated attacks with aura |
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Interventions | Sumatriptan 6 mg, n = 90 (88 for efficacy, 47 with moderate or severe baseline pain intensity) Placebo, n = 87 (83 for efficacy, 35 with moderate or severe baseline pain intensity) |
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Outcomes | Headache relief (at 1 h) Adverse events Withdrawals |
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Notes | Oxford Quality Score: R1, DB2, W1. Total = 4. | |
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 |
Low risk | Matching placebo |
Study size | High risk | Treatment groups <50 participants |