Appleton 1999.
Methods | Randomised, double‐blind, placebo‐controlled, parallel‐group study (conducted at 54 centres in Europe, South Africa, and the US) Prospective pre‐randomisation baseline period: 6 weeks Treatment period: 12 weeks |
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Participants | All children Cross‐continent study. Total randomised 247; all with drug‐resistant focal seizures (15% to 16% had generalised seizures also) 128 to placebo; 119 to gabapentin 54% male Age range: 3‐12 years Other AEDs: ≤ 3 Baseline seizure frequency per 28 days: median 26.7 (range 1.3 to 2893) |
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Interventions | Gabapentin 600‐1800 mg/day (equivalent to 23.2‐35.3 mg/kg/day) Placebo |
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Outcomes | Proportion with a 50% reduction in seizure frequency Response ratio Adverse effects |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation not specified |
Allocation concealment (selection bias) | Unclear risk | No details provided |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Study mentions double‐blinding; no details |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All evaluated on an ITT basis |
Selective reporting (reporting bias) | Low risk | Published reports include all prespecified, expected outcomes. The parent/guardian and physician global assessment of participant seizure frequency and well‐being |
Other bias | High risk | Trial sponsored by Parke Davis Study appeared free of other sources of bias |