Verity 1995.
| Methods | Open‐label, multicentre trial across 63 centres in UK and Ireland 2 treatment arms: CBZ and VPS |
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| Participants | Children with newly onset primary generalised epilepsy or partial epilepsy with/without generalisation or with a recurrence of seizures following withdrawal of AED treatment were eligible given that no anticonvulsants had been received in the previous 6 months Number randomised: CBZ = 130, VPS = 130 122 boys (47%) 108 participants with partial epilepsy (42%) Mean age (range): 10 (5‐16) years |
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| Interventions | Monotherapy with CBZ or VPS Mean daily dose achieved by month 24 CBZ = 450 mg/d, VPS = 700 mg/d Range of follow‐up: 2‐59 months |
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| Outcomes | Remission analysis (time to 6‐, 12‐ and 24‐month remission) Retention analysis (time to treatment failure) Adverse event incidence Incidence of treatment failures due to poor seizure control and adverse events |
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| Notes | IPD provided for all outcomes of this review by trial sponsor Sanofi. Results in the published paper are given for 244 children out of 260 analysed by "intention to treat" (children randomised and with data for at least one follow‐up visit). IPD is provided for all 260 children randomised and will be used for analyses in this review | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were randomised to treatment using a computerised minimisation programme with stratification for age, sex, seizure type and centre |
| Allocation concealment (selection bias) | Low risk | Treatment allocation was concealed via central telephone allocation from the Trial Office at Sanofi Winthrop LTD |
| 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, ITT approach, 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 |