Methods | Randomised, single‐centre, open‐label trial conducted in Scotland, UK 2 treatment arms LTG and VPS |
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Participants | Participants of at least 13 years with a minimum of 2 newly onset unprovoked seizures of any type and no previous exposure to LTG or VPS Number randomised: LTG = 117, VPS =109 114 male participants (50%) 154 participants with partial epilepsy (68%) Mean age (range): 36 (13 ‐ 80 years) |
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Interventions | Monotherapy with LTG or VPS Titration of 5‐10 weeks to target doses of LTG = 200 mg/d and VPS = 1000 mg/d Range of follow‐up: 0‐51 months |
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Outcomes | Percentage of randomised participants achieving a minimum period of 12 months' seizure freedom Percentage of randomised participants withdrawing due to adverse events Percentage of randomised participants with lack of efficacy at maximum tolerated dose Changes in levels of androgenic hormone levels (testosterone, androstenedione and sex hormone‐binding globulin levels) Changes in weight and BMI from baseline |
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Notes | IPD provided for all outcomes of this review by trial author | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Trial described as randomised, no further information provided |
Allocation concealment (selection bias) | Unclear risk | No information provided |
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 from the ITT population 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 | High risk | There were inconsistencies between rates of seizure recurrence and reasons for withdrawal between the data provided and the published paper, which the authors could not resolve |