Lead Investigator: Sarah Nevitt, University of Liverpool
Title of Proposal Research: Antiepileptic drug monotherapy for epilepsy: an updated Cochrane review and individual participant data network meta-analysis
Vivli Data Request: 5291
Funding Source: Yes: The update of the Cochrane IPD-NMA of antiepileptic drugs will be funded by the National Institute for Health Research (UK) upon receipt of the completed work (NIHR 129904 £19,950.42)
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Epilepsy is a common neurological condition, believed to account for 1% of the total global burden of disease. People with epilepsy experience recurrent, unprovoked seizures are caused by abnormal electrical discharges from the brain. There are two types of epileptic seizures which will be studied within this updated review, focal seizures that start in one area of the brain, and generalised onset tonic‐clonic seizures that start in both cerebral hemispheres simultaneously. It is believed that with effective drug treatment, up to 70% of individuals with active epilepsy have the potential to become seizure free and go into long-term remission of seizures shortly after starting therapy with a single antiepileptic drug (AED monotherapy). Currently in the UK, National Institute for Health and Care Excellence (NICE) guidelines for adults and children recommend carbamazepine or lamotrigine as the first treatment options to try for individuals with newly diagnosed focal seizures and sodium valproate for individuals with newly diagnosed generalised tonic‐clonic seizures. However, a range of other AEDs are available.
The choice of the first antiepileptic drug for an individual with newly diagnosed seizures is of great importance and should be made taking into account high‐quality evidence of how effective the drugs are at controlling seizures and whether they are associated with side effects. It is also important that drugs appropriate for different seizure types are compared to each other.
Our previous Cochrane review results supported current NICE guidelines, and also demonstrated that newer AED levetiracetam may be a good alternative treatment. New studies comparing AEDs have been published since our previous review was published in 2017. Therefore we will update our previous review with new evidence. NICE guidelines within the UK are in the process of being updated. The results of our updated review will provide up to date and high quality evidence to directly inform these guidelines within the UK for future individuals with newly diagnosed seizures and will provide wider evidence to inform a choice for decision makers, clinicians or individuals with epilepsy between appropriate drugs available for the initial treatment of epilepsy.
A Multi-Center, Open-label, Randomized Study to Evaluate the Long Term Effectiveness of Levetiracetam as Monotherapy in Comparison With Oxcarbazepine in Subjects With Newly or Recently Diagnosed Partial Epilepsy
Sponsor: Korea UCB Co., Ltd.
Study ID: NCT01498822
Sponsor ID: N01367
A Multicenter, Double-blind, Double-dummy, Randomized, Positive- Controlled Study Comparing the Efficacy and Safety of Lacosamide (200 to 600 mg/Day) to Controlled Release Carbamazepine (400 to 1200 mg/Day), Used as Monotherapy in Subjects (≥ 16 Years) Newly or Recently Diagnosed With Epilepsy and Experiencing Partial-onset or Generalized Tonic-clonic Seizures.
Study ID: NCT01243177
Sponsor ID: SP0993
(Note: Below study was denied due to being subject to legal, contractual or consent provisions that prevent further sharing of clinical data)
An Open-label, Randomized, Parallel-group, Active-controlled Study Comparing the Efficacy and Safety of Levetiracetam to Carbamazepine Used as Monotherapy in Subjects Newly or Recently Diagnosed as Epilepsy and Partial-onset Seizures
Sponsor: UCB Pharma SA
Study ID: NCT01954121
Sponsor ID: N01364