Established Status Epilepticus Treatment Trial



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:2 - Any
Updated:1/7/2018
Start Date:October 2015
End Date:July 2020
Contact:Jaideep Kapur, MBBS, PhD
Email:jk8t@virginia.edu
Phone:434-924-5312

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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.

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.


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
We found this trial at
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Lexington, Kentucky 40536
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Ann Arbor, MI 48109Bus: -
Ann Arbor, Michigan 48109
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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700 Childrens Drive
Columbus, Ohio 43205
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6071 West Outer Drive
Detroit, Michigan 48235
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
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3400 Spruce St
Philadelphia, Pennsylvania 19104
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
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593 Eddy Street
Providence, Rhode Island 02903
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Ann Arbor, Michigan 48109
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80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
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22 S Greene St
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Brooklyn, New York 11203
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4802 10th Ave
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Jaideep Kapur, MBBS, PhD
Phone: 434-924-5312
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Chester, Pennsylvania 19013
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Columbus, Ohio 43210
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Dallas, Texas 75390
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Detroit, Michigan 48202
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
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2799 W Grand Blvd
Detroit, Michigan 48202
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6401 France Ave S
Edina, Minnesota 55435
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Hershey, Pennsylvania 17033
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6621 Fannin St
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Milwaukee, Wisconsin 53226
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
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Minneapolis, Minnesota 55414
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3401 N Broad St
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320 E North Ave
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640 Jackson Street
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Salt Lake City, Utah 84143
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