Donati 2007

Methods	Multicentre, randomised, open‐label trial conducted at 21 sites in seven European countries between December 2001 and December 2003 3 treatment arms: CBZ, OXC, VPS (randomised in a 1:2:1 ratio)
Participants	Children and adolescents (aged 6‐17) with newly diagnosed partial seizures. Participants must have had at least 2 unprovoked partial seizures (simple and complex partial and partial evolving into secondarily generalised seizures) in the 3 months prior to study entry Number randomised: CBZ = 28, OXC = 55, VPS = 29 51 male participants (46%) 100% of participants had partial epilepsy Median age (range): 10 (6‐16)
Interventions	Monotherapy with CBZ, OXC or VPS Dose achieved (mean (SD)): CBZ =14.4 (3.6) mg/kg/d, VPS = 20.7 (7.5) mg/kg/d Study duration: 6 months, Range of follow‐up not stated
Outcomes	Cognitive testing: Computerized Visual Searching Task, assessing mental information processing speed and attention. Rey Auditory Verbal Learning Test and Raven’s Standard Progressive matrices for children: psychomotor speed, alertness, memory and learning, and non‐verbal intelligence. Percentage of participants remaining seizure‐free throughout treatment Most common adverse events Treatment satisfaction on a 4‐point scale from poor to very good
Notes	IPD requested from trial sponsor Novartis but data could not be provided due to time elapsed since the trial was completed.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	An interactive voice‐response system was used to automate the randomisation of participants to treatment groups within age strata
Allocation concealment (selection bias)	Low risk	An interactive voice‐response system was used to automate the randomisation of participants to treatment groups within age strata
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study (justified as primary and secondary cognitive outcomes were objective)
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open‐label study (justified as primary and secondary cognitive outcomes were objective)
Incomplete outcome data (attrition bias) All outcomes	High risk	Attrition rate reported. Most results reported only for the per‐protocol population who completed the study
Selective reporting (reporting bias)	Low risk	All cognitive, efficacy, and tolerability outcomes specified in the methods sections were reported well in the results section. No protocol was available. Outcomes chosen for this review were not reported
Other bias	Low risk	None detected