Rothner 2006.
Study characteristics | ||
Methods | Randomized, double‐blind, placebo‐controlled, parallel‐group trial of oral zolmitriptan | |
Participants | Participants were from the United States (40 sites), Canada (10 sites), India (23 sites), Finland, Germany, and the United Kingdom. Eligible participants were aged 12‐17 years with a diagnosis of migraine with or without aura per the IHS 1988 criteria and were required to have 2‐10 migraine or non‐migraine headaches per month lasting longer than 4 h without treatment in the last 3 months preceding screening Randomized (N = 850); did not treat at least 1 attack (N = 151); intention‐to‐treat and primary efficacy analysis (N = 696) |
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Interventions | Each participant treated 1 migraine attack with oral zolmitriptan (2.5 mg, 5 mg, or 10 mg) or placebo no later than 1 h after the onset of moderate or severe headache, more than 24 h had elapsed since the last migraine attack and the migraine attack occurred within 12 weeks of randomization. Participants were allowed to take an approved escape medication 2 or more h after study treatment. | |
Outcomes |
Other reported outcomes:
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Headache severity scale | 4‐point scale (none, mild, moderate, severe) | |
Funding source | AstraZeneca | |
Publication | Journal and clinical trial registry | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "numbers allocated sequentially as patients entered the study" |
Allocation concealment (selection bias) | Unclear risk | Quote: "The randomization schedule was produced by the Biometrics Group of AstraZeneca." |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "three tablets, all of which were identical in appearance" |
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 |