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

Winner 2007.

Study characteristics
Methods Randomized, double‐blind, parallel‐group, placebo‐controlled trial of oral eletriptan
Participants Participants were 12‐17 years, met ICHD‐2 criteria for migraine with or without aura, and suffered at least 1 migraine attack every 6 weeks. Mean migraine duration was required to be a minimum of 4 h.
Randomized (N = 348); did not receive study medication (N = 74); intention‐to‐treat and primary efficacy analysis (N = 274)
Interventions Eletriptan 40 mg PO, placebo taken within 4 h of headache onset
Outcomes
  • Headache relief at 2 h (reduction from moderate or severe to mild or no pain)

  • Pain‐free at 2 h

  • Presense of nausea

  • Use of rescue medications (within 24 h)

  • Headache recurrence (within 2 to 24 h)

  • Adverse events


Other reported outcomes:
  • Headache relief and pain‐free at 1 h

  • Presence of photophobia or phonophobia

  • Change in functional impairment

  • Migraine‐free (no headache and no associated symptoms at 2 h

  • Acceptability of medication

Headache severity scale 4‐level (none, mild, moderate, severe)
Funding source Pfizer
Publication Journal
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: no information provided
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", but no other description
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "Three hundred and eighty‐four were screened, of whom 348 were randomized to study drug . . ."; "Seventy‐four were randomized but did not take the study drug: (1) 35 did not treat a migraine attack during the 12‐week time window. . ."
Comment: withdrawals balanced across intervention groups
Selective reporting (reporting bias) Low risk Comment: all expected outcomes reported; originally published as an abstract in 2000 (Pitman 2000) followed by this full report.

AE: adverse events; DHE: dihydroergotamine; LOCF: last observation carried forward; PO: per os (by mouth); VAS: visual analogue scale.