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Established Status Epilepticus Treatment Trial (ESETT)

This study is currently recruiting participants.
Verified May 2017 by Jaideep Kapur, MD, University of Virginia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01960075
First Posted: October 10, 2013
Last Update Posted: May 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Michigan
Medical University of South Carolina
Children's Research Institute
University of Minnesota - Clinical and Translational Science Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Jaideep Kapur, MD, University of Virginia
  Purpose

The primary objective is to determine the most effective and/or the least effective treatment of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and valproic acid (VPA).

The second objective is comparison of three drugs with respect to secondary outcomes.

The final objective is to ensure that the trial is informative for treatment of established SE in children by describing the effectiveness, safety, and rate of adverse reactions of these drugs in children.


Condition Intervention Phase
Benzodiazepine Refractory Status Epilepticus Drug: Fosphenytoin Drug: Levetiracetam Drug: Valproic acid Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Blinded, Comparative Effectiveness Study of Fosphenytoin, Valproic Acid, or Levetiracetam in the Emergency Department Treatment of Patients With Benzodiazepine-refractory Status Epilepticus.

Resource links provided by NLM:


Further study details as provided by Jaideep Kapur, MD, University of Virginia:

Primary Outcome Measures:
  • Clinical cessation of status epilepticus [ Time Frame: Within 60 minutes after the start of study drug infusion ]
    Determined by the absence of clinically apparent seizures and improving responsiveness without the use of additional anti-seizure medication


Secondary Outcome Measures:
  • Occurrence of life threatening hypotension or cardiac arrhythmia [ Time Frame: Within 60 minutes after the start of study drug infusion ]
  • Admission to ICU [ Time Frame: 7 days from enrollment ]
  • Time to termination of seizures [ Time Frame: Within 60 minutes after the start of study drug infusion ]
  • Intubation [ Time Frame: Within 60 minutes after the start of study drug infusion ]
  • Seizure recurrence [ Time Frame: Within 60 minutes after the start of study drug infusion ]
  • Mortality [ Time Frame: Within 30 days of randomization ]
  • Richmond agitation and sedation score [ Time Frame: Within 60 minutes after the start of study drug infusion ]
  • Length of stay in the ICU and hospital [ Time Frame: Within 30 days of randomization ]

Other Outcome Measures:
  • Effectiveness in children [ Time Frame: Within 60 minutes after the start of study drug infusion ]
    Final objective is to determine the effectiveness, rate of adverse reactions of these drugs in children with established status epilepticus.


Estimated Enrollment: 795
Study Start Date: October 2015
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fosphenytoin (FOS)
Administer 20 mg/Kg fosphenytoin intravenously up to a maximum dose of 1500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 1500 fosphenytoin over 10 minutes.
Drug: Fosphenytoin
Active Comparator: Valproic acid
Administer 40 mg/Kg valproic acid intravenously up to a maximum dose of 3000 mg (75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 3000 valproic acidover 10 minutes.
Drug: Valproic acid
Active Comparator: Levetiracetam
Administer 60 mg/Kg levetiracetam intravenously up to a maximum dose of 4500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 4500 levetiracetam over 10 minutes.
Drug: Levetiracetam

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Patient witnessed to seize for greater than 5 minute duration prior to treatment with study drug; Patient received adequate dose of benzodiazepines. The last dose of a benzo was administered in the 5-30 minutes prior to study drug administration. The doses may be divided.; continued or recurring seizure in the Emergency Department; Age 2 years or older

Exclusion Criteria:Known pregnancy; Prisoner; Opt-out identification; Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital or other agents defined in the MoP) for this episode of SE; Treatment with sedatives with anticonvulsant properties other than benzodiazepines (propofol, etomidate, ketamine or other agents defined in the MoP); Endotracheal intubation; Acute traumatic brain injury; Known metabolic disorder; Known liver disease; Known severe renal impairment; Known allergy or other known contraindication to FOS, PHT, LEV, or VPA; Hypoglycemia < 50 mg/dL; Hyperglycemia > 400 mg/dL; Cardiac arrest and post-anoxic seizures

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960075


Contacts
Contact: Jaideep Kapur, MBBS, PhD 434-924-5312 jk8t@virginia.edu
Contact: Sonya Gunter 434-924-9664 sag7bf@virginia.edu

  Show 63 Study Locations
Sponsors and Collaborators
University of Virginia
University of Michigan
Medical University of South Carolina
Children's Research Institute
University of Minnesota - Clinical and Translational Science Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Study Chair: Jaideep Kapur, MBBS, PhD University of Virginia
Principal Investigator: Robert Silbergleit, MD University of Michigan
Principal Investigator: James Chamberlain, MD Children's National Health System
Principal Investigator: Jordan Elm, PhD Medical University of South Carolina
  More Information

Additional Information:
Publications:
Responsible Party: Jaideep Kapur, MD, Professor of Neurology and Neuroscience, University of Virginia
ClinicalTrials.gov Identifier: NCT01960075     History of Changes
Other Study ID Numbers: 18078
119756 ( Other Identifier: ClinicalTrials.gov )
U01NS088034 ( U.S. NIH Grant/Contract )
First Submitted: October 8, 2013
First Posted: October 10, 2013
Last Update Posted: May 2, 2017
Last Verified: May 2017

Keywords provided by Jaideep Kapur, MD, University of Virginia:
status epilepticus, refractory, benzodiazepine, fosphenytoin, levetiracetam, valproic acid

Additional relevant MeSH terms:
Status Epilepticus
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Fosphenytoin
Valproic Acid
Phenytoin
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers