Brodie 2007.
Methods | Randomised, double‐blind, parallel‐group trial conducted at 85 centres in 12 European countries and in South Africa 2 treatment arms: CBZ (controlled release) and LEV |
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Participants | Adults (> 16 years) with 2 partial or generalised tonic–clonic seizures separated by at least 48 h in the previous year with at least one seizure in the last 3 months Number randomised: CBZ = 291, LEV = 288 319 male participants (55%) 466 participants with partial epilepsy (80%) Mean age (range): 39 (15‐82 years) |
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Interventions | Monotherapy with CBZ or LEV Titration for 2 weeks to target dose of CBZ = 400 mg/d, LEV = 1000 mg/d Range of follow‐up = 0‐28 months |
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Outcomes | Proportion of per‐protocol (PP) participants achieving at least 6 months of seizure freedom at the last evaluated dose One year seizure‐freedom rate 6‐month and 1‐year seizure‐freedom rate by dose level Time to trial withdrawal Incidence of adverse events |
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Notes | IPD provided for all outcomes of this review by trial sponsor UCB | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised following a central 1:1 randomisation scheme with a statistical block size of 2 and stratified by seizure category |
Allocation concealment (selection bias) | Low risk | Participants were randomised using an interactive voice‐response system |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | To ensure blinding, LEV and CBZ‐CR tablets were identically encapsulated. |
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, ITT approach, 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 |