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 |