Methods | Randomised, open‐label trial to evaluate event‐related potentials on the effect of CBZ and LEV cognitive functions, conducted in Italy 2 treatment arms, CBZ (controlled release) and LEV |
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Participants | Participants with newly diagnosed partial epilepsy Number randomised: CBZ = 14, LEV = 13 14 male participants (52%) 100% of participants had partial epilepsy Mean age (years): CBZ = 38, LEV = 42, range not stated |
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Interventions | Monotherapy with CBZ or LEV Fifteen‐day titration to CBZ = 800 mg/d and LEV = 100 mg/d Trial duration: 24 weeks (assessments at baseline and 12 weeks), range of follow‐up not stated |
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Outcomes | Event‐related potential recordings Neuropsychological assessments |
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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 | |
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 | 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 | Unclear risk | Attrition rates reported (3 dropouts from the CBZ group, 11% of total participants). These participants are excluded from analysis; this is not an ITT approach |
Selective reporting (reporting bias) | Unclear risk | Cognitive outcomes described in methods section well reported in results section. No seizure outcomes or adverse events reported and outcomes chosen for this review not reported. No protocol available so unclear if seizure outcomes were planned a priori |
Other bias | Low risk | None identified |