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

Fujita 2014.

Study characteristics
Methods Randomized, double‐blind, placebo‐controlled, parallel group trial of oral sumatriptan
Participants Participants from 17 centres in Japan were 10‐17 years of age, diagnosed with migraine with or without aura per ICHD‐2 criteria for a minimum of 6 months, and 2‐8 attacks monthly lasting for > 3 h in the last 2 months prior to entry.
Randomized (N = 178); withdrawn (N = 34); intention‐to‐treat and primary efficacy analysis (N = 144)
Interventions Oral sumatriptan 25 mg (1 tablet and 1 matching placebo), sumatriptan 50 mg (2 tablets), or placebo (2 tablets) taken as soon as possible (within 30 minutes) after the development of a migraine with grade 3 or more pain
Outcomes

  • Headache relief (reduction of 2 grades) at 2 h

  • Pain‐free at 2 h

  • Presence of nausea, vomiting at 2 h

  • Use of rescue medications from time of dosing to 4 h post‐treatment

  • Adverse events


Other reported outcomes:

  • Headache relief, pain‐free, photophobia, phonophobia, and vomiting at 0.5, 1, and 4 hours post‐treatment
Headache severity scale 5‐grade scale
Funding source GlaxoSmithKline
Publication Journal and Clinical Trial Registry
Notes —
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Investigator (or subinvestigator) completed the registration form and sent it to the randomization center by facsimile. The randomization center. . . assigned a randomization number to the patient."
Allocation concealment (selection bias) Low risk Quote: "For allocation of the participants, a computer‐generated list of random numbers was used."
Blinding (performance bias and detection bias)
All outcomes Low risk Quote: "The investigator (or subinvestigator) dispensed the investigational product to the patient according to the computer‐generated randomization number."
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: used last observation carried forward (LOCF)
Selective reporting (reporting bias) Low risk Comment: all stated outcomes were reported