Abstracts

Rationale: The EpiNet project has been set up to run investigator-initiated clinical trials. EpiNet-First will be the first international randomised controlled trials undertaken by the EpiNet study group. The EpiNet-First trials are based closely on the SANAD-2 study being run in Great Britain. -New onset epilepsy is common, so a good clinical scenario in which to conduct our first trial -The study endpoints are clear, easily determined, and clinically meaningful -The study will provide a clear focus to the EpiNet project -The SANAD-2 trial will act as a control for the EpiNet-First trialsMethods: Investigators: Any adult or child neurologist is welcome to participate. Investigators must complete an initial validation study, and obtain approval from relevant local authorities. Design: Pragmatic, unblinded randomised controlled trials. The studies are designed as non-inferiority studies. Participants: Adults and children over the age of 5 who have had 2 or more unprovoked epileptic focal or generalised tonic-clonic seizures, who require treatment, and who have not previously been treated with AEDs. 2860 patients will be required across the 4 trials. Primary Endpoint: Time to 12 month remission - measured in weeks. Secondary endpoints: Time to treatment failure; 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; Adverse events. Randomisation: Information on patients with epilepsy who have not previously been treated with an AED will be entered into the EpiNet database. Once the patient consent form has been signed, the patient will then be randomised on-line. Trial 1: Patients with focal seizures will be randomised to either lamotrigine or levetiracetam Trial 2: Patients with generalised seizures (except those with absence seizures only) will be randomised to either sodium valproate or levetiracetam Trial 3: If sodium valproate is unsuitable, then patients with generalised seizures will be randomised to either lamotrigine or levetiracetam. Trial 4: Patients with seizures of unknown nature will be randomised to either levetiracetam, lamotrigine, or sodium valproate. All trial medication will be prescribed in a formulation and at a dose deemed suitable by the treating physicians. Patients will be followed at 3 months, 6 months, 1 year and 2 years, and annually thereafter until the completion of the study. All follow-up data will be recorded in the EpiNet database. Timeline: Study Duration: Minimum participant duration 2 years. We anticipate that we will start recruiting before the end of 2013. Centres will join the study as and when they obtain the required approvals. The trials will continue until the required number of patients have been recruited and followed for a minimum of 2 years. The 4 arms will be regarded as separate trials, and different trials are likely to close at different times. Results: The study will continue for several years.Conclusions: EpiNet-First will be the first trials conducted by the EpiNet study group. All epileptologists and neurologists are encouraged to participate.