Methods | Phase IV, open‐label, randomised, multicentre trial conducted in 21 centres in Republic of Korea 2 treatment arms: CBZ and LTG |
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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 |
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Interventions | Monotherapy with CBZ or LTG Permitted doses LTG: 100 mg/d–500 mg/d for LTG , CBZ: 400 mg/d–1200mg/d |
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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 |
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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 |