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Trial record 4 of 13 for:    cerebyx

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 - Clinical and Translational Science Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Jaideep Kapur, MD, University of Virginia

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.


Condition or disease Intervention/treatment Phase
Benzodiazepine Refractory Status Epilepticus Drug: Fosphenytoin Drug: Levetiracetam Drug: Valproic acid Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
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.
Study Start Date : October 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. Occurrence of life threatening hypotension or cardiac arrhythmia [ Time Frame: Within 60 minutes after the start of study drug infusion ]
  2. Admission to ICU [ Time Frame: 7 days from enrollment ]
  3. Time to termination of seizures [ Time Frame: Within 60 minutes after the start of study drug infusion ]
  4. Intubation [ Time Frame: Within 60 minutes after the start of study drug infusion ]
  5. Seizure recurrence [ Time Frame: Within 60 minutes after the start of study drug infusion ]
  6. Mortality [ Time Frame: Within 30 days of randomization ]
  7. Richmond agitation and sedation score [ Time Frame: Within 60 minutes after the start of study drug infusion ]
  8. Length of stay in the ICU and hospital [ Time Frame: Within 30 days of randomization ]

Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
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


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


  Hide Study Locations
Locations
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United States, Arizona
Banner University Medical Center - South Campus
Tucson, Arizona, United States, 85713
Banner University Medical Center-Tucson Campus
Tucson, Arizona, United States, 85724
United States, California
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
UC Davis Children's Hospital
Sacramento, California, United States, 95817
San Francisco General Hospital
San Francisco, California, United States, 94110
UCSF Medical Center
San Francisco, California, United States, 94143
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94145
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
A.I.DuPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20310
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
United States, Kentucky
University of Kentucky Hospital
Lexington, Kentucky, United States, 40536
United States, Maryland
University of maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sinai-Grace Hospital
Detroit, Michigan, United States, 48235
United States, Minnesota
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55454
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States, 55455
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Kings County Hospital Center
Brooklyn, New York, United States, 11203
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Maimonides Medical Center
Brooklyn, New York, United States, 11219
NYP Columbia University Medical Center
New York, New York, United States, 10032
NYP Morgan Stanley Children's Hospital
New York, New York, United States, 10032
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
OSU Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health & Science University Hospital
Portland, Oregon, United States, 97239
United States, Pennsylvania
Crozer-Chester Medical Center
Chester, Pennsylvania, United States, 19013
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Temple University Hospital Episcopal Campus
Philadelphia, Pennsylvania, United States, 19125
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, United States, 15219
Children's Hospital of Pittsburgh UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02903
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
Children's Medical Center UTSW
Dallas, Texas, United States, 75390
Lyndon B. Johnson General Hospital
Houston, Texas, United States, 77026
Memorial Hermann Texas medical Center
Houston, Texas, United States, 77030
Texas Children's Hospital
Houston, Texas, United States, 77030
University Health System University Hospital
San Antonio, Texas, United States, 78229
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
VCU Medical Center
Richmond, Virginia, United States, 23298
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
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
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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

Additional Information:
Publications:
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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 Posted: October 10, 2013    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Keywords provided by Jaideep Kapur, MD, University of Virginia:
status epilepticus, refractory, benzodiazepine, fosphenytoin, levetiracetam, valproic acid
Additional relevant MeSH terms:
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Fosphenytoin
Status Epilepticus
Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Phenytoin
Levetiracetam
Valproic Acid
Anticonvulsants
Nootropic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers
Membrane Transport Modulators
Voltage-Gated Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers