Jung 2015.
| Methods | Multicenter, randomised, open‐label, non‐inferiority trial conducted across 7 centres in Republic of Korea 2 treatment arms: CBZ and LEV |
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| Participants | Children aged 4‐16 years with newly diagnosed focal epilepsy, no previous anti‐epileptic therapy and "above borderline" intelligence Number randomised: CBZ = 64, LEV = 57 (ITT population) 69 male participants (57%) 100% of participants with partial epilepsy Mean age (SD): CBZ = 8.05 (3.02), LEV = 9.28 (3.37) years |
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| Interventions | Monotherapy with CBZ or LEV 4‐week dose titration period to a minimal target dose of CBZ = 20/mg/kg/d or LEV = 40/mg/kg/d Trial duration: 52 weeks, range of follow‐up not stated |
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| Outcomes | Neuropsychological outcomes; change from baseline to 52 weeks in neurocognitive (Korean‐WISC‐III or Korean‐Wechsler Preschool and Primary Scale of Intelligence‐III), behavioural (Korean‐CBCL), and emotional (Children's Depression Inventory and Revised Children's Manifest Anxiety Scale) function assessments Mean percentage change in seizure frequency from baseline Seizure‐freedom rates Incidence of adverse events |
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| Notes | IPD could not be provided for the trial due to restrictions on data sharing from the Korean Food and Drug Administration (information provided by corresponding author). Outcomes chosen for this review were not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were randomised independently at each centre using a computerised random code assignment based on stratified permuted block randomisation that were designed separately and independently for each participating centre |
| Allocation concealment (selection bias) | Low risk | At each centre, allocation concealment was carried out by the pharmacy in order to blind those assessing outcomes from the trial medication |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label trial for participants and personnel |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Those assessing outcomes were blinded to trial medication (pharmacy allocation) |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 7 randomised participants did not take any trial medication so were not included in ITT population. Results for neuropsychological outcomes recorded only for those who completed the trial ‐ 81/121 participants (67%) |
| Selective reporting (reporting bias) | Low risk | All neuropsychological, efficacy, and tolerability outcomes specified in the methods sections were reported well in the results section. No protocol was available. Outcomes chosen for this review were not reported |
| Other bias | Low risk | None identified |