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Trial record 7 of 39 for:    neurology AND University AND San Francisco | Open Studies

Established Status Epilepticus Treatment Trial (ESETT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by University of Virginia
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
ClinicalTrials.gov Identifier:
NCT01960075
First received: October 8, 2013
Last updated: November 3, 2016
Last verified: November 2016
  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: Double Blind (Subject, 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 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960075

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

  Hide Study Locations
Locations
United States, Arizona
Banner University Medical Center - South Campus Not yet recruiting
Tucson, Arizona, United States, 85713
Banner University Medical Center-Tucson Campus Not yet recruiting
Tucson, Arizona, United States, 85724
United States, California
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
UC Davis Children's Hospital Recruiting
Sacramento, California, United States, 95817
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
UCSF Medical Center Recruiting
San Francisco, California, United States, 94143
UCSF Benioff Children's Hospital Recruiting
San Francisco, California, United States, 94145
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
United States, Delaware
Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
A.I.DuPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20310
United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Children's Healthcare of Atlanta at Egleston Recruiting
Atlanta, Georgia, United States, 30322
United States, Kentucky
University of Kentucky Hospital Recruiting
Lexington, Kentucky, United States, 40536
United States, Maryland
University of maryland Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
C.S. Mott Children's Hospital Not yet recruiting
Ann Arbor, Michigan, United States, 48109
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Detroit Receiving Hospital Recruiting
Detroit, Michigan, United States, 48201
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Sinai-Grace Hospital Recruiting
Detroit, Michigan, United States, 48235
United States, Minnesota
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55454
University of Minnesota Masonic Children's Hospital Recruiting
Minneapolis, Minnesota, United States, 55455
Regions Hospital Recruiting
St. Paul, Minnesota, United States, 55101
United States, Missouri
St. Louis Children's Hospital Recruiting
St. Louis, Missouri, United States, 63110
United States, New York
Kings County Hospital Center Not yet recruiting
Brooklyn, New York, United States, 11203
SUNY Downstate Medical Center Not yet recruiting
Brooklyn, New York, United States, 11203
NYP Columbia University Medical Center Recruiting
New York, New York, United States, 10032
NYP Morgan Stanley Children's Hospital Recruiting
New York, New York, United States, 10032
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Nationwide Children's Hospital Recruiting
Columbis, Ohio, United States, 43205
OSU Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health & Science University Hospital Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Crozer-Chester Medical Center Recruiting
Chester, Pennsylvania, United States, 19013
Penn State Hershey Medical Center Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Hahnemann University Hospital Not yet recruiting
Philadelphia, Pennsylvania, United States, 19102
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Penn Presbyterian Medical Center Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Allegheny General Hospital Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15212
UPMC Presbyterian Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
UPMC Mercy Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15219
Children's Hospital of Pittsburgh UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Hasbro Children's Hospital Recruiting
Providence, Rhode Island, United States, 02903
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
United States, Texas
Children's Medical Center UTSW Recruiting
Dallas, Texas, United States, 75390
Lyndon B. Johnson General Hospital Recruiting
Houston, Texas, United States, 77026
Memorial Hermann Texas medical Center Recruiting
Houston, Texas, United States, 77030
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Jaideep Kapur, MBBS, PhD    434-924-5312    jk8t@virginia.edu   
Contact: Sonya Gunter, MS    434-924-9664    sag7bf@virginia.edu   
Principal Investigator: Jaideep Kapur, MBBS, PhD         
VCU Medical Center Not yet recruiting
Richmond, Virginia, United States, 23298
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Froedtert Memorial Lutheran Hospital Recruiting
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
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  U01NS088034 
Study First Received: October 8, 2013
Last Updated: November 3, 2016

Keywords provided by 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
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
Nootropic Agents
Neuroprotective Agents
Protective Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers

ClinicalTrials.gov processed this record on February 24, 2017