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. 2017 Dec 15;2017(12):CD011412. doi: 10.1002/14651858.CD011412.pub3

ACTRN12615000641594.

Trial name or title EpiNet‐First Trial 5: Comparison of efficacy of levetiracetam and lamotrigine in people with previously untreated epilepsy who have unclassified seizures, and for whom sodium valproate is not deemed an acceptable AED
Methods Phase 4 randomised, open‐label, pragmatic trial conducted across sites in New Zealand and Europe
2 treatment arms: LEV and LTG
Participants Individuals > 5 years with ≥ 2 spontaneous generalised seizures that require AED treatment (provided all seizures have not been absence seizures)
Target sample size = 664
Interventions Monotherapy with LEV or LTG
Target doses LEV: 250 mg‐4000 mg, LTG: 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 antiepileptic medication
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 ACTRN12615000641594 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