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. 2016 Apr 19;2016(4):CD005220. doi: 10.1002/14651858.CD005220.pub2

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)
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
  • Headache relief at 2 h (pain decrease from moderate or severe to mild or none)

  • Pain free

  • Adverse events


Other reported outcomes:
  • Other time points including 30 and 60 min

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