Privitera 2003

Methods	Multinational, randomised, double‐blind trial was conducted at 115 centres across the USA, Canada, Europe and South America Four treatments: CBZ, VPS and TPM (2 arms, 100 mg/d and 200 mg/d) ‐ see Notes
Participants	Participants > 6 years and > 30 kg in weight, with a diagnosis of epilepsy within the 3 months before trial entry and no previous AED treatment except emergency treatment Number randomised (ITT population): CBZ = 126, TPM = 266 (CBZ branch), VPS = 78, TPM = 147 (VPS branch) 327 male participants (53%) 363 participants with partial epilepsy (59%) Mean age (range): 34 (6‐84 years)
Interventions	Monotherapy with CBZ, VPS or TPM Starting doses: CBZ = 200 mg/d, VPS = 250 mg/d, TPM = 25 mg/d Target doses (after 4‐week titration): CBZ = 600 mg/d, VPS = 1000 mg/d, TPM = 100 or 200 mg/d (see Notes) Range of follow‐up: 0‐29 months
Outcomes	Time to exit Time to first seizure Proportion of seizure‐free participants during the last 6 months of double‐blind treatment Safety assessment: most commonly occurring adverse events
Notes	IPD provided for all outcomes of this review by trial sponsor Johnson & Johnson. Trial designed in 2 strata based on whether recommended treatment would be CBZ or VPS. Within the 2 strata, participants were randomised to 10 mg/d TPM, 200 mg/d TPM or CBZ/VPS depending on the strata. Data analysed according to the separate strata in this review with the 2 TPM doses analysed together (see Data extraction and management)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was balanced using permuted blocks of size three and stratified by trial centre, according to a computer‐generated randomisation schedule prepared by the trial sponsor
Allocation concealment (selection bias)	Unclear risk	No information provided
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Trial was double‐blinded for the first 6 months, followed by an open‐label phase
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information provided
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition rates reported, ITT approach, all randomised participants from the ITT population analysed from IPD provided (see footnote 2). Eight participants with no follow‐up data were excluded from ITT population
Selective reporting (reporting bias)	Low risk	All outcomes reported or calculated with IPD provided (see footnote 2)
Other bias	Low risk	None identified