Methods | Randomised, single‐centre, open‐label, parallel‐group trial conducted at Tel Aviv University and Medical Centre, Israel 2 treatment arms: LTG and CBZ |
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Participants | Adults admitted to the neurological department with a first seizure event after an ischaemic stroke Number randomised: LTG = 32, CBZ = 32 46 male participants (72%) 100% of participants had partial epilepsy Unclear if any participants had received previous AED treatment Mean age (range): 67.5 (38‐90) years |
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Interventions | Monotherapy with LTG or CBZ for 12 months Dose escalation phase (length not stated) leading to LTG 100 mg/d, CBZ 300 mg/d Range of follow‐up: not stated |
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Outcomes | The appearance of a second seizure under treatment or by finishing the 12‐month follow‐up without seizures Tolerability: incidence of adverse events Withdrawals due to adverse events |
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Notes | Contact made with trial author who was willing to provide IPD but data never received. Aggregate data extracted from graphs in the publication. Stated in the title of the paper that LTG and CBZ were monotherapy treatments but Table 1 of the paper refers to Total no. AED, unclear if all participants were receiving monotherapy treatment | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised in a 1:1 ratio, no further information provided |
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 | Low risk | Attrition rate reported, all randomised participants included in analysis |
Selective reporting (reporting bias) | Low risk | No protocol available. Seizure outcomes and adverse events well reported |
Other bias | Unclear risk | Unclear if all participants were receiving monotherapy treatment |