Skip to main content
. 2018 Jun 28;2018(6):CD001031. doi: 10.1002/14651858.CD001031.pub4

Brodie 1999.

Methods Randomised, multicentre, double‐blind, parallel‐group trial conducted in the UK
2 treatment arms: LTG and CBZ randomised in a 2:1 ratio
Participants Adults over the age of 65 with newly diagnosed epilepsy with 2 or more seizures in the previous year with at least 1 seizure in the last 6 months
Number randomised: LTG = 102, CBZ = 48
83 males (55%)
105 with focal seizures (70%)
Not stated if any participants had received previous AED treatment
Mean age (range): 77 (65 to 94) years
Interventions Monotherapy with LTG or CBZ for 24 weeks
4‐week escalation phase leading to LTG = 100 mg/day, CBZ = 400 mg/day
Range of follow‐up = 0 to 280 days
Outcomes Time to first seizure after 6 weeks of treatment
Time to treatment withdrawal
Percentage of patients reporting an adverse event
Proportion of patients who were both seizure‐free in the last 16 weeks of the trial and did not discontinue treatment
Notes IPD provided by trial sponsor GlaxoSmithKline for time to treatment failure and time to first seizure (plus seizure freedom rates at 24 weeks)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random sequence (information provided by drug manufacturer). Participants randomised in a 2:1 ratio (LTG:CBZ)
Allocation concealment (selection bias) Low risk Allocation concealed with pharmacy‐dispensed treatment packs labelled with participant's trial number
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blind achieved using LTG tablets formulated to be identical in appearance to CBZ tablets
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Trial investigator blinded, not stated if other outcome assessors were blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Attrition rates reported; all randomised participants analysed from IPD provided (see footnote 2)
Selective reporting (reporting bias) Low risk All outcomes reported or calculated with IPD provided (see footnote 2)
Other bias Low risk None identified