Rothner 1999a.
Study characteristics | ||
Methods | Randomized, double‐blind, placebo‐controlled, parallel‐group 3‐attack trial of oral sumatriptan | |
Participants | Participants from 62 centers in 7 countries were 12‐17 years of age with a minimum 6‐month history of migraine with or without aura per IHS 1988 criteria and 1‐6 attacks per month Randomized (N = 347); withdrawn (N = 117); intention‐to‐treat and primary efficacy analysis (N = 273) |
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Interventions | Each participant treated 1 migraine with oral sumatriptan 25 mg, 50 mg, 100 mg, or placebo. No maximum time after the onset of migraine was specified. | |
Outcomes |
Other reported outcomes:
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Headache severity scale | 4‐point scale (none, mild, moderate, severe) | |
Funding source | GlaxoSmithKline | |
Publication | Abstract and clinical trial registry | |
Notes | Headache alleviation: reduction in headache from grade 3 or 2 to grade 1 or 0 within 2 h where 3 = headache, I can't do anything; 2 = headache, I can do easy activities; 1 = headache, I can carry on as usual; and 0 = no headache. Funding: not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: described as randomized but no details |
Allocation concealment (selection bias) | Unclear risk | Comment: no description of allocation concealment |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comment: no description of efforts to maintain blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: missing outcome data balanced across intervention groups |
Selective reporting (reporting bias) | Low risk | Comment: all expected outcomes reported |