Abstracts

Rationale: The EpiNet project was established to encourage multicentre studies for people with epilepsy. It combines research with routine clinical care, and was an initiative of the New Zealand league against epilepsy. We wish for clinicians to take a bigger role in organizing and running research studies. The EpiNet study group has commenced 2 studies in people with newly diagnosed epilepsy. 1) an observational study of patients commencing their first AED; 2) a series of pragmatic, unblinded, randomised controlled trials in patients with new onset epilepsy in which levetiracetam is compared with standard AEDs. Methods: EpiNet-First trials The 5 EpiNet-First trials are comparative effectiveness trials. The primary endpoint is 12 months sustained seizure freedom. Patients are allocated to the different trials according to the type of seizures they experience. Trials are not blinded. - Trial 1 Patients with focal seizures are randomized (1:1:1) to levetiracetam, lamotrigine or carbamazepine. - Trial 2 Patients with generalized seizures are randomized (1:1) to sodium valproate or levetiracetam. - Trial 3 If sodium valproate is not suitable, patients with generalized seizures are randomized (1:1) to lamotrigine or levetiracetam. - Trial 4 Patients with seizures of unknown nature are randomized (1:1:1) to either levetiracetam, lamotrigine, or sodium valproate. - Trial 5 If sodium valproate is not suitable, patients with seizures of unknown nature are randomised (1:1) to levetiracetam or lamotrigine. Investigators are not paid for recruiting patients. We have obtained Ethics and Institutional Review Board approvals as necessary. All patients give informed consent. First AED Registry If patients with new-onset epilepsy do not wish to be randomized or they cannot be entered into the EpiNet-First trials, or the trials are not approved in the investigator's center, investigators are asked to record the AED prescribed. They are asked why this drug was chosen. Records are to be updated at least once per year. We want to know if patients have further seizures, if the AED is changed or subsequent AEDs are added, and why changes are made. This registry will serve as a 'real-world' comparison for the EpiNet-First trials. Results: The EpiNet-FIrst trials and First AED registry are multinational studies, but this presentation focuses on the Auckland experience. These studies commenced in Auckland, New Zealand, in May 2015. By June 3rd, 2016, 72 patients had been randomized. Across the 5 trials, 28 patients had been randomized to levetiracetam, 25 to lamotrigine, 11 to valproate, and 8 to carbamazepine. Over the same time period, 67 patients had been entered into the First AED registry. Levetiracetam 29; lamotrigine 16; sodium valproate 15; phenytoin 4; carbamazepine 2. Conclusions: Over the course of a year, 72 patients with new-onset epilepsy from a single center (Auckland) have been recruited into the EpiNet-First trials, and 67 patients have been registered in the First AED registry. Auckland has a population of 1.5 million people. If neurologists and epileptologists from other centers can register patients at similar rates, then these studies will rapidly attain the numbers needed to inform clinicians about the respective merits of different AEDs in new-onset epilepsy. Epileptologists and neurologists from around the world are encouraged to participate in these studies (www.epinet.co.nz). Funding: Health Research Council of New Zealand; Neurological Foundation of New Zealand; Julius Brendel Trust