Methods | Multicentre, randomised, double-blind, placebo-controlled, parallel-group. Single dose to treat up to 3 successive attacks Medication administered at the first sign of headache pain Assessments at 1, 2, 3, 4, 6, 8, and 24 hours after dosing Second injection available to participants after 2 h to treat recurrence of headache or if the response to the initial injection had been inadequate Rescue medication (non-ergotamine) was permitted 2 h after the second injection |
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Participants | Aged 18 to 65, at least 6-month history of migraine (diagnostic criteria equivalent to IHS 1988) without aura Frequency of 1 to 6 attacks per month in the past 12 months, characterised by slow developing headache (the time interval between onset of mild headache and development of moderate or severe headache had to be consistently greater than 1 hour) N = 349 M 62, F 287 (82%) Mean age 40 years 100% without aura |
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Interventions | Sumatriptan 6 mg, n = 136 Placebo, n = 113 |
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Outcomes | Serious 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 | Treatment groups 50 to 200 participants |