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Epilepsy Behav. 2019 Oct 22:106296. doi: 10.1016/j.yebeh.2019.04.049. [Epub ahead of print]

Lessons from the Established Status Epilepticus Treatment Trial.

Author information

1
St George's University of London and Atkinson Morley Regional Epilepsy Network, St George's University Hospitals NHS Foundation Trust, London, UK. Electronic address: hannahrc@sgul.ac.uk.
2
Department of Experimental and Clinical Pharmacology, College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis, MN, USA.
3
Department of Public Health Science, Medical University of South Carolina, Charleston, SC, USA.
4
Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.
5
Division of Emergency Medicine, Children's National Health System and the Department of Pediatrics and Emergency Medicine, School of Medicine and Health Sciences, George Washington University Washington, DC, USA.
6
Department of Neurology (Fountain, Kapur), Brain Institute, University of Virginia, Charlottesville, VA, USA.
7
Departments of Neurology, Pediatrics and Epidemiology and Population Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA.
8
Department of Neurology, University of California, San Francisco, CA, USA.
9
National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.
10
Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
11
Department of Neurology (Fountain, Kapur), Brain Institute, University of Virginia, Charlottesville, VA, USA; Department of Neuroscience (Kapur), Brain Institute, University of Virginia, Charlottesville, VA, USA.

Abstract

Convulsive status epilepticus (SE) is a relatively common emergency condition affecting individuals of all ages. The primary goal of treatment is prompt termination of seizures. Where first-line treatment with benzodiazepine has failed to achieve this, a condition known as established SE (ESE), there is uncertainty about which agent to use next. The Established Status Epilepticus Treatment Trial (ESETT) is a 3-arm (valproate (VPA), fosphenytoin (FOS), levetiracetam (LEV)), phase III, double-blind randomized comparative effectiveness study in patients aged 2 years and above with established convulsive SE. Enrollment was completed in January 2019, and the results are expected later this year. We discuss lessons learnt during the conduct of the study in relation to the following: ethical considerations; trial design and practical implementation in emergency settings, including pediatric and adult populations; quality assurance; and outcome determination where treating emergency clinicians may lack specialist expertise. We consider that the ESETT is already informing both clinical practice and future trial design. This article is part of the Special Issue "Proceedings of the 7th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures".

KEYWORDS:

Clinical trial; Levetiracetam; Methodology; Phenytoin; Status epilepticus; Valproate

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