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. 2018 Oct 24;2018(10):CD001415. doi: 10.1002/14651858.CD001415.pub3

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
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)
Interventions Gabapentin 600‐1800 mg/day (equivalent to 23.2‐35.3 mg/kg/day)
Placebo
Outcomes Proportion with a 50% reduction in seizure frequency
Response ratio
Adverse effects
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