ACTRN12615000556549

Trial name or title	EpiNet‐First Trial 2: Comparison of efficacy of levetiracetam and sodium valproate in people with previously untreated epilepsy who have generalised seizures
Methods	Phase 4 randomised, open‐label, pragmatic trial conducted across sites in New Zealand and Europe 2 treatment arms: LEV and VPS
Participants	Individuals > 5 years with ≥ 2 spontaneous generalised seizures that require AED treatment (provided all seizures have not been absence seizures) Target sample size = 506
Interventions	Monotherapy with LEV or VPS Target doses LEV: 250 mg‐4000 mg, VPS: 250 mg‐400 mg
Outcomes	Time to 12‐month remission from seizures Proportion of participants who achieve a seizure‐free 12‐month remission by 18 months AND who have not changed to a different AED Time to treatment failure due to either inadequate seizure control, or due to unacceptable adverse events Time to treatment failure due to inadequate seizure control. Time to treatment failure due to unacceptable adverse events. Time to first seizure Time to 24‐month remission. Serious adverse events attributed to the trial medication or other AED. Quality of life as assessed by the QOLIE31 and QOLIE48 questionnaires
Starting date	May 2015
Contact information	Dr Peter Bergin (pbergin@adhb.govt.nz)
Notes	Trial is registered as ACTRN12615000556549 on the Australian New Zealand Clinical Trials Registry and is listed as currently recruiting participants (correct to August 2016) Estimated finish date is May 2018