NCT01498822

Methods	Phase 4, randomised, parallel‐design, open‐label trial in Republic of Korea 2 treatment arms: LEV and OXC
Participants	Participants aged16‐80 years with newly diagnosed partial epilepsy Partcipants must have had at least 2 seizures separated by a minimum of 48 h and 1 in the 6 months prior to screening and no AEDs in the previous 6 months Number enrolled: LEV = 175, OXC = 178 190 male participants (54%) 100% of participants had partial epilepsy Mean age (SD): LEV = 39.5 (16.7), OXC = 42.7 (17.3)
Interventions	Monotherapy with LEV or OXC Titration for 2 weeks up to a maximum of LEV = 1000 mg/d‐3000 mg/d, OXC = 900 mg/d‐24,000 mg/d Trial duration: 50 weeks, range of follow‐up not stated
Outcomes	Percentage of participants with a treatment failure after 50 weeks Time to the first seizure defined as the time from the first dose of medication to the occurrence of the first seizure during the 48 weeks' treatment period Percentage of subjects who achieved seizure freedom for 24 consecutive weeks during the 48 weeks' treatment period at any time Percentage of subjects who achieved seizure freedom during the 48 weeks' treatment period
Notes	Trial registered as NCT001498822 on ClincalTrials.gov and listed as completed and trial results published online but no published manuscript was available. Trial sponsored by UCB Korea, 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)	Low risk	Results for all outcomes reported online for listed outcomes
Other bias	Low risk	None identified