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. Author manuscript; available in PMC: 2014 Sep 15.
Published in final edited form as: Cochrane Database Syst Rev. 2012 Feb 15;2:CD009665. doi: 10.1002/14651858.CD009665
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
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
Interventions Sumatriptan 6 mg, n = 117 attacks
Placebo, n = 109 attacks
Outcomes Headache relief (at 1 and 2 h)
Pain-free (at 1 h)
Use of rescue medication
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 Number in each treatment arm for first attack not reported