Methods | Open‐label, parallel‐design, multicentre RCT conducted at 16 centres in the USA 2 treatment arms: PHT and VPS randomised in a 2:1 ratio |
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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, VPS = 86 73 male participants (54%) 0% participants with partial epilepsy (all generalised epilepsy) Mean age (range): 21 (3‐64 years) |
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Interventions | Monotherapy with PHT or VPS Starting doses PHT: 3 mg/kg/d‐ 5 mg/kg/d, VPS: 10 mg/kd/d‐15 mg/kg/d, doses gradually increased. Doses achieved not stated Range of follow‐up: 0‐11 months |
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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 by the Department of Veteran's Affairs (maximum follow‐up 6 months, therefore trial could not contribute to outcome, 'Time to 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 VPS: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; trial authors state that differences in adverse events of PHT and VPS would "quickly unblind" the trial anyway |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label trial; trial authors state that differences in adverse events of PHT and VPS 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 | None identified |