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

Rothner 1999c.

Study characteristics
Methods Randomized, double‐blind, placebo‐controlled, parallel‐group trial of oral sumatriptan
Participants Participants were from 18 centers in 8 countries and 12‐17 years of age with migraine with or without aura per IHS 1988 criteria; treated 1 attack following a run‐in period of up to 8 weeks during which their usual medication was used to treat 1 migraine attack
Randomized (N = 139); withdrawn (N = 37); intention‐to‐treat and primary efficacy analysis (N = 102)
Interventions Oral sumatriptan 50 mg (30 to 50 kg) or sumatriptan 100 mg (> 50 kg) versus placebo
Outcomes

  • Headache/disability relief (grade 2/3 to 0/1) at 2 h

  • Pain free at 2 h

  • Presence of nausea

  • Use of rescue medication after 4 h

  • Headache recurrence within 24 h

  • Adverse events


Other reported outcomes:

  • 4 h time point

  • Presense of photophobia or phonophobia

  • Time to headache improvement

  • Time to disappearance of headache

  • Time to resumption of normal activities

  • Time to feeling 'completely back to normal'

  • Global response to study medication
Headache severity scale Headache/clinical disability score (grade 3 = headache ‐ "I can’t do anything"; grade 2 = headache – "I can do easy activities"; grade 1 = headache – "I can carry on as usual", grade 0 = no headache)
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 Comment: described as "randomized in a 1:1:1 ratio. . ."
Allocation concealment (selection bias) Unclear risk Comment: no description of methods to maintain allocation concealment
Blinding (performance bias and detection bias)
All outcomes Unclear risk Comment: described as "double‐blind"; previous studies by sponsor had adequate blinding procedures
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: withdrawals balances between intervention groups
Selective reporting (reporting bias) Unclear risk Comment: outcomes extensively reported in the GlaxoSmithKline clinical trial registry