Rothner 1999b.
Study characteristics | ||
Methods | Randomized, double‐blind, placebo‐controlled, parallel‐group trial of oral sumatriptan | |
Participants | Participants from Canada (14 sites) were aged 12‐17 years, had a 3‐month history of migraine with or without aura as per the IHS 1988 criteria (except headaches could be < 2 h) and the migraine attack had lasted < 24 h. Randomized (N = 119); withdrawn (N = 27); intention‐to‐treat and primary efficacy analysis (N = 92) |
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Interventions | Each participant treated 1 migraine with oral sumatriptan (50 mg for body weight 30‐50kg; 100 mg for body weight > 50kg) or placebo. Use of rescue medication was permitted after 4 h of study treatment. | |
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 | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Subjects were randomized (1:1:1 ratio) to receive. . ." |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comment: described as "placebo‐controlled"; participant‐reported outcomes |
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 |