Ho 2012.

Study characteristics
Methods	Randomized, double‐blind, placebo‐controlled, parallel group trial of oral rizatriptan with an enrichment design
Participants	Participants were males and females aged 6–17 years who were ≥ 20kg in weight and who had at least a 6‐month history of migraine attacks with or without aura as defined by ICHD‐2, usually lasting 3 h or more (when untreated). Participants had ≥ 1 and ≤ 8 moderate to severe migraine attacks with or without aura per month in the 2 months before the screening visit, and had not, by history, experienced satisfactory relief with NSAIDs or paracetamol. Patients were excluded if they had not experienced satisfactory relief from migraine pain during prior treatment with 2 or more adequate courses of triptans. Non‐responders to placebo in stage 1 were randomized 1:1 to rizatriptan:placebo, with randomization stratified by age (6–11 years versus 12–17 years). Randomized (N = 1382); not treated (N = 405); randomized in stage 1 (N = 915); randomized in stage 2 (N = 791); withdrawn (N = 21); intention‐to‐treat and primary efficacy analysis (N = 770)
Interventions	Oral‐disintegrating tablet of rizatriptan 5 mg (< 40 kg) or 10 mg (≥ 40 kg) or placebo. Participants treated within 30 min of a moderate/severe migraine attack. In stage 1, participants were randomized 20:1 to placebo or rizatriptan. In stage 2, participants with ongoing moderate/severe pain after 15 min (non‐responders) who received placebo in stage 1 were randomized 1:1 to rizatriptan or placebo.
Outcomes	Pain‐free at 2 h Pain relief (reduction of at least 2 grades from baseline) at 2 h Vomiting, nausea free at 2 h Use of rescue medications within 24 h Adverse events Other reported outcomes: Sustained pain‐free 24 and 48 h post‐treatment Photophobia‐free, phonophobia‐free at 2 h
Headache severity scale	4‐point scale (none, mild, moderate, severe)
Funding source	Merck
Publication	Journal and abstract
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: randomization process not described
Allocation concealment (selection bias)	Unclear risk	Comment: allocation performed using interactive voice response system
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Comment: no information provided
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: withdrawals are balanced between intervention groups
Selective reporting (reporting bias)	Low risk	Comment: all expected outcomes reported including adverse events