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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Randomised trial of participants with epileptic seizures following stroke conducted in Italy
2 treatment arms: CBZ (controlled release) and LEV
Participants Participants with "vascular epilepsy", newly onset following stroke. Not stated if participants had been previously treated with AEDs
Number randomised: CBZ = 17, LEV = 18
17 male participants (49%)
Proportion of participants with partial epilepsy not stated
Mean age: 70 (43‐90) years
Interventions Monotherapy with CBZ or LEV
Dose achieved: CBZ: 400 mg/d‐1200 mg/d, LEV = 1000 mg/d‐3000 mg/d
Trial duration and range of follow‐up not stated
Outcomes Seizure freedom
Adverse events during the trial
Discontinuations of the trial drug
Notes The trial was published in Italian; the characteristics and outcomes were translated. Outcomes chosen for this review were not reported; IPD were not available (author confirmed that the data had been lost)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The trial was described as randomised ('randomizzazione' in Italian); no further information was available
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) All outcomes Unclear risk No information provided
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, no formal statistical analysis performed so withdrawals did not influence results
Selective reporting (reporting bias) Unclear risk Methods brief, efficacy and tolerability reported in the results. Outcomes chosen for this review not reported. No protocol available so unclear which outcomes were planned a priori
Other bias Low risk None identified