Methods | Prospective, open‐label randomised trial conducted in Serbia and Montenegro 2 treatment arms: LTG and VPS |
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Participants | Participants with newly diagnosed, previously untreated epilepsy Number randomised: LTG = 35, VPS = 38 51 (70%) with partial epilepsy Median age (range): 34 (18‐76) years No information on gender |
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Interventions | Monotherapy with LTG or VPS All participants to be followed up for at least 6 months |
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Outcomes | Seizure freedom Retention on treatment |
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Notes | Abstract of interim results only available. Contact was made with trial author who was unable to provide IPD | |
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 | Unclear risk | Interim report, proportion of participants completing the trial period presented. Unclear if an ITT approach was taken to analysis |
Selective reporting (reporting bias) | Unclear risk | Abstract only, insufficient information to make a judgement |
Other bias | Low risk | None identified |