Levisohn 2009 & Loge 2010.
| Methods | Randomised, double‐blind, placebo‐controlled trial 2 treatment arms: 1 PCB and 1 LEV Randomisation concealment: method not stated. Random list generation: no explicit statement of sequence‐generation method, but patients were randomised either to LEV or PCB in a 2:1 ratio. Randomisation was stratified for age (4 to 7, 8 to 12, 13 to 16 years) and number of concomitant AEDs (1 or 2) Blinding: descried as double‐blind without further specification aside from stating that neurocognitive testing was carried out by the same experienced, blinded neuropsychologist Baseline: 4 weeks historical, 1 week prospective. Treatment period = 12 weeks (4 weeks' titration, 8 weeks' maintenance) |
|
| Participants | All children. Multicentre (28) across the US, Canada, and South Africa Total randomised 98 children 34 children to PCB 64 children to LEV 60 mg/kg/day 50% male in PCB, 61% male in LEV Age range 4.1 to 16.7 years Other AEDs: 1 or 2 ≥ 1 focal seizure during 4 weeks before screening Diagnosis of focal epilepsy made ≥ 6 months before screening Mean duration of epilepsy (years): not given Median baseline seizure frequency per week: LEV = 0.9 (IQR 0.4 to 1.9); PCB = 1.4 (IQR 0.4 to 5.2) |
|
| Interventions | LEV 60 mg/kg/day PCB add‐on Up‐titration dosages = 20 mg/kg/day orally twice a day as tablets or 10% solution, up‐titrated in increments of 20 mg/kg/day every 2 weeks |
|
| Outcomes | ≥ 50% reduction in seizure frequency Treatment withdrawal Adverse effects Cognitive effects Behavioural and emotional functioning |
|
| Notes | Cognitive assessment was done using Leiter‐R AM, WRAML‐2, and Leiter‐R ERS Behavioural and emotional functioning were assessed using CBCL and CHQ‐PF50 Cognitive, behavioural, and emotional function results were shown only for the per protocol population: 46 in LEV, 27 in PCB A few participants had generalised‐onset (1 in LEV, 1 in PCB) or unclassified seizures (1 in PCB), or both, in addition to partial‐onset seizures |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | B ‐ Unclear |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | B ‐ Unclear |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | B ‐ Unclear |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | A ‐ Adequate |
| Selective reporting (reporting bias) | Low risk | A ‐ Adequate |