Methods | Parallel, randomised, double‐blind study, with partial cross‐over to open‐label (at treatment failure only) with subsequent follow‐up. Follow‐up 12 months. | |
Participants | 453 drug naive participants (193 male, 260 female), aged between 7 months to 12 years 11 months. All participants with typical absence seizures. | |
Interventions | Monotherapy with LTG, VPS, or ESM. | |
Outcomes | Freedom from treatment failure assessed 12 months after randomisation. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random sequence was generated using permuted blocks. |
Allocation concealment (selection bias) | Low risk | Central allocation. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Placebo and active drugs indistinguishable. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo and active drugs indistinguishable. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Placebo and active drugs indistinguishable. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data. |
Selective reporting (reporting bias) | Low risk | The study protocol is not available but it is clear that the published reports include all expected outcomes. |
EEG: electroencephalogram ESM: ethosuximide LTG: lamotrigine PCB: placebo VPA: valproic acid VPS: sodium valproate