Trial ID or NCT#

NCT01960075

Status

NOT RECRUITING

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.

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.

Eligibility Criteria

Ages Eligible for Study: Older than 2 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

James Quinn
Emergency medicine doctor, Pediatric emergency medicine doctor
Professor of Emergency Medicine and, by courtesy, of Health Research and Policy at the Stanford University Medical Center
Peter D'Souza
Emergency medicine doctor, Pediatric emergency medicine doctor
Clinical Associate Professor, Emergency Medicine
Karen G. Hirsch, MD
Neurocritical care specialist
Associate Professor of Neurology and, by courtesy, of Neurosurgery at the Stanford University Medical Center

Contact us to find out if this trial is right for you.

CONTACT

Rosen Mann
650.721.2645