Skip to main content
. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Randomised, double‐blind, parallel‐group trial conducted in 29 centres across Croatia, Finland, France, Finland and Norway
2 treatment arms: LTG and CBZ
Participants Adults > 65 years with newly diagnosed seizures, with a history of at least 2 seizures and at least 1 seizure in the previous 6 months. Participants must not have taken AEDs for more than 2 weeks in the previous 6 months and never taken CBZ or LTG
Number randomised: LTG = 93, CBZ = 92
102 male participants (54%)
Proportion with partial epilepsy not stated
Not stated how many participants had received previous AED treatment
Mean age: 74 (65‐91) years
Interventions Monotherapy with LTG or CBZ
4‐week escalation phase leading to LTG = 100 mg/d, CBZ = 400 mg/d
Trial duration 40 weeks. Range of follow‐up: not stated
Outcomes Retention in the trial (time to treatment withdrawal for any cause)
Seizure freedom after week 4
Seizure freedom after week 20
Time to first seizure
Adverse event reports
Tolerability according to the Liverpool Adverse Event profile (AEP)
Notes IPD requested from trial sponsor Glaxo Smith Kline but data could not be located.
Aggregate summary data extracted from the publication
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described as randomised, no other information provided
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) All outcomes Low risk Double blind achieved with double dummy tablets, packaged together
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, all participants who received trial treatment were included in an ITT analysis
Selective reporting (reporting bias) Low risk No protocol available but clinical trial summary provided by the sponsor. Seizure outcomes and adverse events well reported
Other bias Low risk None identified