Skip to main content
. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Randomised, single‐centre, open‐label, parallel‐group trial conducted at Tel Aviv University and Medical Centre, Israel
2 treatment arms: LTG and CBZ
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
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
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
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