Established Status Epilepticus Treatment Trial

Not Recruiting

Trial ID: NCT01960075


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.

Stanford Investigator(s)

James Quinn
James Quinn

Professor of Emergency Medicine, Emeritus

Peter D'Souza

Clinical Associate Professor, Emergency Medicine


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


drug: Fosphenytoin

drug: Levetiracetam

drug: Valproic acid

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Rosen Mann