Methods | Parallel trial Study conducted at 16 centres in the United States Participants assigned via randomisation tables within each centre in a 2:1 ratio (SV:PHT) Method of allocation concealment not stated Unblinded |
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Participants | Participants with at least 2 newly diagnosed and previously untreated primary generalised tonic‐clonic seizures within 14 days of starting the trial Number randomised: PHT = 50; SV = 86 0% participants with partial epilepsy, 73 (54%) men Mean age (range): 21 (3‐64 years). Participants followed up for up to 6 months |
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Interventions | Monotherapy with PHT or SV Starting doses PHT: 3‐5 mg/kg/day, SV: 10‐15 mg/kg/day, doses gradually increased Doses achieved not stated |
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Outcomes | Time to first generalised tonic‐clonic seizure 6‐month seizure recurrence rates Adverse events |
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Notes | IPD provided for 3/4 outcomes of this review (maximum follow‐up 6 months, therefore trial cannot contribute to outcome 'Time to achieve 12‐month remission') | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants randomised on a 2:1 ratio SV:PHT using randomisation tables in each centre (information provided by trial author) |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label trial; authors state that differences in adverse events of PHT and SV would "quickly unblind" the trial anyway |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label trial, authors state that differences in adverse events of PHT and SV would "quickly unblind" the trial anyway |
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 | No other bias detected |