Methods | Randomised, multicentre, open‐label, parallel‐group trial conducted in 7 hospitals in Republic of Korea 2 treatment arms: LTG and CBZ |
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Participants | Children aged 6‐12 years with a new diagnosis of partial epilepsy and at least 2 seizures in the last 6 months. Number randomised: LTG = 43, CBZ = 41 48 male participants (57%) 100% of participants had partial epilepsy Not stated if any participants had received previous AED treatment Mean age (range): 9 (5‐13) years |
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Interventions | Monotherapy with LTG or CBZ 8‐week escalation phase leading to LTG = 3‐6 mg/kg/d, CBZ = 10‐20 mg/kg/d Range of follow‐up: 0.5‐28 months |
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Outcomes | Seizure‐free rate over 6 months (maintenance period) by treatment group Change in cognition (neuropsychological), behaviour and quality of life from screening to the end of the maintenance phase by treatment group Incidence of adverse events |
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Notes | IPD provided by trial author for time to treatment withdrawal, time to first seizure and time to 6‐month remission | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Each centre received a separate and independent computer‐ generated random code list |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label trial |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rates reported, all randomised participants analysed from IPD provided (see footnote 2) |
Selective reporting (reporting bias) | Low risk | All outcomes reported or calculated with IPD provided (see footnote 2) |
Other bias | Low risk | None identified |