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 |
Other reported outcomes:
|
|
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.