Visser 2004a.

Study characteristics
Methods	Randomized, double‐blind, placebo‐controlled, parallel‐group single‐attack trial of oral rizatriptan
Participants	Participants from 44 centers in the United States 12‐17 years of age with a 1 year history of migraine with or without aura per IHS 1988 criteria and 1‐8 attacks per month. Randomization was stratified by age (12‐14 and 15‐17 years). Randomized (N = 686); did not take study medication (N = 210); primary efficacy analysis (N = 476)
Interventions	Each participant treated 1 migraine with oral rizatriptan (5 mg) or placebo within 30 minutes of onset. Up to 2 recurrences could be treated with the same medication. Participants could only treat migraine attacks on days they were not in school or at camp.
Outcomes	Headache relief at 2 h (reduction from moderate or severe to mild or none) Pain free at 2 h Headache recurrence within 24 h Presence of nausea or vomiting Adverse events Other reported outcomes: Presense of photophobia or phonophobia Other time points (0.5, 1, 1.5, 3, and 4 h), Functional ability Headache severity
Headache severity scale	4‐level (none, mild, moderate, severe)
Funding source	Merck
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 double‐blind
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "The number of patients who discontinued prior to taking study medication and the distribution of reasons for the lack of treatment were comparable across the treatment arms."
Selective reporting (reporting bias)	Low risk	Comment: all expected outcomes reported