Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
Status: Recruiting
Location: See all (47) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The goal of this clinical trial is to determine if treatment of patients with two doses of ketamine plus levetiracetam versus levetiracetam alone leads to more effective control of status epilepticus.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: f
View:
• The patient was witnessed to have a convulsive seizure for greater than 5-minute duration
• The patient received an adequate dose of benzodiazepines. The doses may be divided.
• The last dose of a benzodiazepine was administered 5-30 minutes before study drug administration.
• Continued or recurring seizures in the Emergency Department.
• Age 1 years or older
• Known or estimated weight ≥10 Kg
Locations
United States
Arizona
Banner University Medical Center - Tucson Campus
NOT_YET_RECRUITING
Tucson
California
Children's Hospital Los Angeles
NOT_YET_RECRUITING
Los Angeles
Ronald Reagan UCLA Medical Center
NOT_YET_RECRUITING
Los Angeles
UC Davis Medical Center
RECRUITING
Sacramento
San Francisco General Hospital
NOT_YET_RECRUITING
San Francisco
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Washington, D.c.
Children's National Medical Center
RECRUITING
Washington D.c.
Delaware
Christiana Hospital
NOT_YET_RECRUITING
Newark
Nemours Children's Hospital
NOT_YET_RECRUITING
Wilmington
Florida
Orlando Regional Medical Center
NOT_YET_RECRUITING
Orlando
Georgia
Arthur M. Blank Hospital
NOT_YET_RECRUITING
Atlanta
Grady Memorial Hospital
NOT_YET_RECRUITING
Atlanta
Iowa
University of Iowa Medical Center
NOT_YET_RECRUITING
Iowa City
Illinois
Comer Children's Hospital
NOT_YET_RECRUITING
Chicago
Northwestern Memorial Hospital
NOT_YET_RECRUITING
Chicago
University of Chicago Medical Center
NOT_YET_RECRUITING
Chicago
Indiana
IU Health Methodist Hospital
NOT_YET_RECRUITING
Indianapolis
Riley Hospital for Children
NOT_YET_RECRUITING
Indianapolis
Massachusetts
Massachusetts General Hospital
NOT_YET_RECRUITING
Boston
Maryland
University of Maryland Medical Center
NOT_YET_RECRUITING
Baltimore
Michigan
University of Michigan University Hospital
RECRUITING
Ann Arbor
Detroit Receiving Hospital
NOT_YET_RECRUITING
Detroit
Henry Ford Hospital
NOT_YET_RECRUITING
Detroit
Minnesota
Hennepin County Medical Center
NOT_YET_RECRUITING
Minneapolis
University of Minnesota Masonic Children's Hospital
NOT_YET_RECRUITING
Minneapolis
University of Minnesota Medical Center
NOT_YET_RECRUITING
Minneapolis
North Carolina
Duke Regional Hospital
NOT_YET_RECRUITING
Durham
Duke University Hospital
NOT_YET_RECRUITING
Durham
New York
SUNY Upstate Medical University
NOT_YET_RECRUITING
Syracuse
Ohio
University of Cincinnati Medical Center
NOT_YET_RECRUITING
Cincinnati
Nationwide Children's Hospital
NOT_YET_RECRUITING
Columbus
Oregon
Oregon Health & Science University Hospital
RECRUITING
Portland
Pennsylvania
Hospital of the University of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
Jefferson Einstein Philadelphia Hospital
NOT_YET_RECRUITING
Philadelphia
Temple University Hospital
RECRUITING
Philadelphia
UPMC Children's Hospital of Pittsburgh
NOT_YET_RECRUITING
Pittsburgh
UPMC Presbyterian Hospital
NOT_YET_RECRUITING
Pittsburgh
Reading Hospital
NOT_YET_RECRUITING
West Reading
Texas
Children's Medical Center Dallas
NOT_YET_RECRUITING
Dallas
Memorial Hermann Texas Medical Center
NOT_YET_RECRUITING
Houston
Utah
Primary Children's Hospital
NOT_YET_RECRUITING
Salt Lake City
University of Utah Healthcare
NOT_YET_RECRUITING
Salt Lake City
Virginia
University of Virginia Medical Center
RECRUITING
Charlottesville
VCU Medical Center
NOT_YET_RECRUITING
Richmond
Washington
Harborview Medical Center
NOT_YET_RECRUITING
Seattle
Wisconsin
Children's Hospital of Wisconsin
NOT_YET_RECRUITING
Milwaukee
Froedtert Hospital
NOT_YET_RECRUITING
Milwaukee
Contact Information
Primary
Megan Wardius
mew5j@virginia.edu
434-243-6768
Time Frame
Start Date: 2026-03-06
Estimated Completion Date: 2029-12
Participants
Target number of participants: 770
Treatments
Active_comparator: Levetiracetam
Levetiracetam (LEV) (60 mg/Kg)
Experimental: Levetiracetam + low dose Ketamine
LEV 60 mg/mL + 1 mg/mL KET
Experimental: Levetiracetam + high dose Ketamine
LEV 60 mg/mL + 3 mg/mL KET increasing up to a weight of 75 kg
Related Therapeutic Areas
Sponsors
Collaborators: Medical University of South Carolina, Children's National Research Institute, University of Michigan, Massachusetts General Hospital
Leads: University of Virginia