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 journalArticlepeer-review

7 Scopus citations

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.

Original languageEnglish (US)
Article number106296
JournalEpilepsy and Behavior
Volume101
DOIs
StatePublished - Dec 2019

Bibliographical note

Funding Information:
Funding: Research discussed in this publication was supported by National Institutes of Health, National Institute of Neurological Disorders and Stroke under Awards U01NS073476, U01NS088034, U01NS088023, U01NS056975, U01NS059041, and R01NS099653.

Funding Information:
Funding: Research discussed in this publication was supported by National Institutes of Health , National Institute of Neurological Disorders and Stroke under Awards U01NS073476 , U01NS088034 , U01NS088023 , U01NS056975 , U01NS059041 , and R01NS099653 .

Publisher Copyright:
© 2019 Elsevier Inc.

Keywords

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

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