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Eligibility
for people ages 2 years and up
Location
at San Francisco, California and other locations
Dates
study started

Description

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.

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.

Keywords

Benzodiazepine Refractory Status Epilepticus status epilepticus, refractory, benzodiazepine, fosphenytoin, levetiracetam, valproic acid Fosphenytoin Etiracetam Valproic Acid Phenytoin Piracetam

Eligibility

You can join if…

Open to people ages 2 years and up

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

You CAN'T join if...

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

Locations

  • Stanford University Medical Center accepting new patients
    Stanford, California, 94305, United States
  • UC Davis Children's Hospital accepting new patients
    Sacramento, California, 95817, United States
  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles, California, 90095, United States

Details

Status
accepting new patients
Start Date
Sponsor
University of Virginia
Links
ESETT Website
ID
NCT01960075
Phase
Phase 3
Study Type
Interventional
Last Updated
May 1, 2017
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