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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Phase IV, open‐label, randomised, multicentre trial conducted in 21 centres in Republic of Korea
2 treatment arms: CBZ and LTG
Participants Participants were untreated epileptics who had at least 2 unprovoked seizures (partial or generalised tonic clonic) during the last 24 weeks before the study start, more than 24 h apart
Number randomised: CBZ = 129, LTG = 264 (ITT population)
154 male participants (39%)
288 participants (73%) with partial epilepsy
Mean age (SD): CBZ = 37.6 (15.8), LTG = 34.2 (16.3) years
Interventions Monotherapy with CBZ or LTG
Permitted doses LTG: 100 mg/d–500 mg/d for LTG , CBZ: 400 mg/d–1200mg/d
Outcomes Retention rate at study end
Terminal 24‐week seizure‐free rate and time interval from the end of dose titration phase to the first seizure
Notes Full text of the trial published in Korean. Abstract and clinical trial summary available in English. IPD request for this trial ongoing.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Trial described as randomised, no further information provided
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 High risk Attrition rate reported, not all participants included in analysis, which is not an ITT approach
Selective reporting (reporting bias) Low risk Results for all outcomes summarised for all listed outcomes
Other bias Low risk None identified