Methods | Randomised trial of participants with epileptic seizures following stroke conducted in Italy 2 treatment arms: CBZ (controlled release) and LEV |
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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 |
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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 |
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Outcomes | Seizure freedom Adverse events during the trial Discontinuations of the trial drug |
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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 |