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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 arrhythmia

Admission 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

Page last updated: August 23, 2015

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