Established Status Epilepticus Treatment Trial
Information source: University of Virginia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benzodiazipine Refractory Status Epilepticus
Intervention: Fosphenytoin (Drug); Levetiracetam (Drug); Valproic acid (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: University of Virginia Official(s) and/or principal investigator(s): Jaideep Kapur, MBBS, PhD, Study Chair, Affiliation: University of Virginia Robert Silbergleit, MD, Principal Investigator, Affiliation: University of Michigan James Chamberlain, MD, Principal Investigator, Affiliation: Children's National Health System Jordan Elm, PhD, Principal Investigator, Affiliation: Medical University of South Carolina
Overall contact: Jaideep Kapur, MBBS, PhD, Phone: 434-924-5312, Email: jk8t@virginia.edu
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Clinical cessation of status epilepticus
Secondary outcome: Occurrence of life threatening hypotension or cardiac arrhythmiaAdmission to ICU Time to termination of seizures Intubation Seizure recurrence Mortality Richmond agitation and sedation score Length of stay in the ICU and hospital
Eligibility
Minimum age: 2 Years.
Maximum age: N/A.
Gender(s): Both.
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.; ontinued 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
Locations and Contacts
Jaideep Kapur, MBBS, PhD, Phone: 434-924-5312, Email: jk8t@virginia.edu
University of Virginia, Charlottesville, Virginia 22908, United States; Not yet recruiting Jaideep Kapur, MBBS, PhD, Phone: 434-924-5312, Email: jk8t@virginia.edu Amy Fansler, MPH, Phone: 434-982-6027, Email: acf7h@virginia.edu Jaideep Kapur, MBBS, PhD, Principal Investigator
Additional Information
Starting date: August 2015
Last updated: May 6, 2015
|