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Lessons from the Established Status Epilepticus Treatment Trial

Cock, HR; Coles, LD; Elm, J; Silbergleit, R; Chamberlain, JM; Cloyd, JC; Fountain, N; Shinnar, S; Lowenstein, D; Conwit, R; et al. Cock, HR; Coles, LD; Elm, J; Silbergleit, R; Chamberlain, JM; Cloyd, JC; Fountain, N; Shinnar, S; Lowenstein, D; Conwit, R; Bleck, T; Kapur, J (2019) Lessons from the Established Status Epilepticus Treatment Trial. Epilepsy and Behavior, 101 (B). p. 106296. ISSN 1525-5050 https://doi.org/10.1016/j.yebeh.2019.04.049
SGUL Authors: Cock, Hannah Rutherford

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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.

Item Type: Article
Additional Information: © 2019. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/
Keywords: 1103 Clinical Sciences, Neurology & Neurosurgery
SGUL Research Institute / Research Centre: Academic Structure > Institute of Medical & Biomedical Education (IMBE)
Academic Structure > Institute of Medical & Biomedical Education (IMBE) > Centre for Clinical Education (INMECE )
Journal or Publication Title: Epilepsy and Behavior
ISSN: 1525-5050
Dates:
DateEvent
22 October 2019Published Online
27 April 2019Accepted
Publisher License: Creative Commons: Attribution-Noncommercial-No Derivative Works 4.0
Projects:
Project IDFunderFunder ID
U01NS073476National Institute of Neurological Disorders and Strokehttp://dx.doi.org/10.13039/100000065
U01NS088034National Institute of Neurological Disorders and Strokehttp://dx.doi.org/10.13039/100000065
U01NS088023National Institute of Neurological Disorders and Strokehttp://dx.doi.org/10.13039/100000065
U01NS056975National Institute of Neurological Disorders and Strokehttp://dx.doi.org/10.13039/100000065
U01NS059041National Institute of Neurological Disorders and Strokehttp://dx.doi.org/10.13039/100000065
R01NS099653National Institute of Neurological Disorders and Strokehttp://dx.doi.org/10.13039/100000065
URI: https://openaccess.sgul.ac.uk/id/eprint/110838
Publisher's version: https://doi.org/10.1016/j.yebeh.2019.04.049

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