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Established Status Epilepticus Treatment Trial (ESETT)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01960075
Recruitment Status : Active, not recruiting
First Posted : October 10, 2013
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
University of Michigan
Medical University of South Carolina
Children's Research Institute
University of Minnesota
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Jaideep Kapur, MD, University of Virginia

Tracking Information
First Submitted Date  ICMJE October 8, 2013
First Posted Date  ICMJE October 10, 2013
Last Update Posted Date April 16, 2019
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 8, 2013)
Clinical cessation of SE without life threatening hypotension or cardiac arrhythmias. [ Time Frame: 60 minutes from enrollment ]
The primary outcome is clinical cessation of status epilepticus, without recurrent seizures, life-threatening hypotension or cardiac arrhythmia, or use of additional anti-seizure medications within 60 minutes of the start of study drug infusion.
Change History Complete list of historical versions of study NCT01960075 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2013)
Admission to ICU, intubation and mortality [ Time Frame: 7 days from enrollment ]
Secondary objective is to measure the impact of the three drugs on secondary outcomes: time to termination of clinical seizures, intubation or admission to ICU within 24 hrs. of enrollment, mortality and clinical cessation of status epileptcis and adverse effects analyzed separately.
Current Other Pre-specified Outcome Measures
 (submitted: May 6, 2015)
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.
Original Other Pre-specified Outcome Measures
 (submitted: October 8, 2013)
Effectiveness in children [ Time Frame: 60 minutes ]
Final objective is to determine the effectiveness, rate of adverse reactions of these drugs in children with established status epilepticus.
 
Descriptive Information
Brief Title  ICMJE Established Status Epilepticus Treatment Trial
Official Title  ICMJE 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.
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Benzodiazepine Refractory Status Epilepticus
Intervention  ICMJE
  • Drug: Fosphenytoin
  • Drug: Levetiracetam
  • Drug: Valproic acid
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Drug: Levetiracetam
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 15, 2019)
478
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2013)
795
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01960075
Other Study ID Numbers  ICMJE 18078
119756 ( Other Identifier: ClinicalTrials.gov )
U01NS088034 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jaideep Kapur, MD, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE
  • University of Michigan
  • Medical University of South Carolina
  • Children's Research Institute
  • University of Minnesota
  • National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
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
PRS Account University of Virginia
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP