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

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Randomized (N = 347); withdrawn (N = 117); intention‐to‐treat and primary efficacy analysis (N = 273)
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
  • Headache relief at 2 h (moderate or severe pain intensity reduced to no or mild pain)

  • Pain free at 2 h

  • Presence of nausea within 4 h

  • Use of rescue medication within 24 h

  • Recurrence of migraine within 4‐24 h

  • Adverse events


Other reported outcomes:
  • Presense of photophobia or phonophobia within 4 h

  • Other time points (headache relief at 1 h was primary outcome in study)

  • Time to meaningful relief

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