NCT01954121

Methods	Phase 3, randomised, open‐label, parallel‐group trial conducted in China 2 treatment arms: CBZ and LEV
Participants	Chinese participants > 16 years, recent onset partial seizures, at least 2 unprovoked seizures in the year preceding randomisation, of which at least 1 unprovoked seizure occurred in the 3 months preceding randomisation Number enrolled: CBZ = 215, LEV = 218 233 male participants (54%) 100% of participants had partial epilepsy Mean age (SD): CBZ = 33.3 (14.3), LEV = 37.8 (16.2)
Interventions	Monotherapy with CBZ or LEV Titration of 3 weeks to CBZ = 400 mg/d, LEV = 1000 mg/d
Outcomes	Proportion of subjects remaining seizure‐free during the 6‐month evaluation period Proportion of subjects retained in the trial for the duration of the period covering the up‐titration period, stabilization period, and evaluation period Time to first seizure or discontinuation due to an adverse event (AE)/lack of efficacy (LOE) during the evaluation period Time to first seizure during the evaluation period Time to first seizure during the period covering the up‐titration period, stabilisation period, and evaluation period from the first dose of trial drug
Notes	Trial registered as NCT01954121 on ClincalTrials.gov and listed as completed and trial results published online but no published manuscript was available. Trial sponsored by UCB SA, inquiries regarding this trial made to the sponsor. Data cannot be made available until a manuscript has been published; if IPD is provided at a future date, this trial will be included in analyses
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)	High risk	Results reported online for only some of the outcomes, no statistical analysis reported for the Time to First Seizure outcomes.
Other bias	Low risk	None identified