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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Randomised, multicentre, open‐label, parallel‐group trial conducted in the UK
3 treatment arms: LTG, GBP, TPM
Participants Adults and children > 4 years with newly diagnosed or relapsed generalised or unclassified epilepsy, or failed treatment with a previous drug not used in this trial.
Number randomised: LTG = 239, VPS = 238; TPM = 239
420 male participants (59%)
52 partial epilepsy (7%)
108 had received previous AED treatment (15%)
Mean age (range): 22.5 (5‐77) years
Interventions Monotherapy for LTG, GBP or TPM
Titration doses and maintenance doses decided by treating clinician
Range of follow‐up: 0‐83.5 months
Outcomes Time to treatment failure
Time to 1‐year (12‐month) remission
Time to 2‐year remission
Time to first seizure
Health‐related quality of life via the NEWQOL (Newly Diagnosed Epilepsy Quality of Life Battery)
Health economic assessment and cost effectiveness of the drugs (cost per QALY gained and cost per seizure avoided)
Frequency of clinically important adverse events
Notes IPD provided for time to treatment withdrawal, time to first seizure, time to six‐month, time to 12‐month and time to 24‐month remission (trial conducted at our site)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer minimisation programme stratified by centre, sex and treatment history
Allocation concealment (selection bias) Low risk Telephone randomisation to a central randomisation allocation service
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 rates reported, all randomised participants analysed from IPD provided (see footnote 2)
Selective reporting (reporting bias) Low risk Protocol provided. All outcomes reported or calculated with IPD provided (see footnote 2)
Other bias Low risk None identified