Overview

Established Status Epilepticus Treatment Trial

Status:
Completed

Trial end date:
2019-05-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Virginia

Collaborators:

Children's National Research Institute
Children's Research Institute
Medical University of South Carolina
National Institute of Neurological Disorders and Stroke (NINDS)
University of Michigan
University of Minnesota
University of Minnesota - Clinical and Translational Science Institute

Treatments:

Etiracetam
Fosphenytoin
Levetiracetam
Phenytoin
Piracetam
Valproic Acid

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