Lessons from the Established Status Epilepticus Treatment Trial

Hannah R. Cock, Lisa D. Coles, Jordan Elm, Robert Silbergleit, James M. Chamberlain, James C. Cloyd, Nathan Fountain, Shlomo Shinnar, Dan Lowenstein, Robin Conwit, Thomas P. Bleck, Jaideep Kapur

Research output: Contribution to journalArticle

1 Citation (Scopus)

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"

Original languageEnglish (US)
Article number106296
JournalEpilepsy and Behavior
DOIs
StateAccepted/In press - Jan 1 2019

Fingerprint

Status Epilepticus
etiracetam
Emergencies
Seizures
Therapeutics
Valproic Acid
Benzodiazepines
Uncertainty
Pediatrics
Population

Keywords

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

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Behavioral Neuroscience

Cite this

Cock, H. R., Coles, L. D., Elm, J., Silbergleit, R., Chamberlain, J. M., Cloyd, J. C., ... Kapur, J. (Accepted/In press). Lessons from the Established Status Epilepticus Treatment Trial. Epilepsy and Behavior, [106296]. https://doi.org/10.1016/j.yebeh.2019.04.049

Lessons from the Established Status Epilepticus Treatment Trial. / Cock, Hannah R.; Coles, Lisa D.; Elm, Jordan; Silbergleit, Robert; Chamberlain, James M.; Cloyd, James C.; Fountain, Nathan; Shinnar, Shlomo; Lowenstein, Dan; Conwit, Robin; Bleck, Thomas P.; Kapur, Jaideep.

In: Epilepsy and Behavior, 01.01.2019.

Research output: Contribution to journalArticle

Cock, HR, Coles, LD, Elm, J, Silbergleit, R, Chamberlain, JM, Cloyd, JC, Fountain, N, Shinnar, S, Lowenstein, D, Conwit, R, Bleck, TP & Kapur, J 2019, 'Lessons from the Established Status Epilepticus Treatment Trial', Epilepsy and Behavior. https://doi.org/10.1016/j.yebeh.2019.04.049
Cock HR, Coles LD, Elm J, Silbergleit R, Chamberlain JM, Cloyd JC et al. Lessons from the Established Status Epilepticus Treatment Trial. Epilepsy and Behavior. 2019 Jan 1. 106296. https://doi.org/10.1016/j.yebeh.2019.04.049
Cock, Hannah R. ; Coles, Lisa D. ; Elm, Jordan ; Silbergleit, Robert ; Chamberlain, James M. ; Cloyd, James C. ; Fountain, Nathan ; Shinnar, Shlomo ; Lowenstein, Dan ; Conwit, Robin ; Bleck, Thomas P. ; Kapur, Jaideep. / Lessons from the Established Status Epilepticus Treatment Trial. In: Epilepsy and Behavior. 2019.
@article{c30a8461969f47e5bca1e8657225c8f3,
title = "Lessons from the Established Status Epilepticus Treatment Trial",
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",
author = "Cock, {Hannah R.} and Coles, {Lisa D.} and Jordan Elm and Robert Silbergleit and Chamberlain, {James M.} and Cloyd, {James C.} and Nathan Fountain and Shlomo Shinnar and Dan Lowenstein and Robin Conwit and Bleck, {Thomas P.} and Jaideep Kapur",
year = "2019",
month = "1",
day = "1",
doi = "10.1016/j.yebeh.2019.04.049",
language = "English (US)",
journal = "Epilepsy and Behavior",
issn = "1525-5050",
publisher = "Academic Press Inc.",

}

TY - JOUR

T1 - Lessons from the Established Status Epilepticus Treatment Trial

AU - Cock, Hannah R.

AU - Coles, Lisa D.

AU - Elm, Jordan

AU - Silbergleit, Robert

AU - Chamberlain, James M.

AU - Cloyd, James C.

AU - Fountain, Nathan

AU - Shinnar, Shlomo

AU - Lowenstein, Dan

AU - Conwit, Robin

AU - Bleck, Thomas P.

AU - Kapur, Jaideep

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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"

AB - 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"

KW - Clinical trial

KW - Levetiracetam

KW - Methodology

KW - Phenytoin

KW - Status epilepticus

KW - Valproate

UR - http://www.scopus.com/inward/record.url?scp=85073967625&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85073967625&partnerID=8YFLogxK

U2 - 10.1016/j.yebeh.2019.04.049

DO - 10.1016/j.yebeh.2019.04.049

M3 - Article

AN - SCOPUS:85073967625

JO - Epilepsy and Behavior

JF - Epilepsy and Behavior

SN - 1525-5050

M1 - 106296

ER -