RecruitingPhase 3NCT06907173

Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)


Sponsor

University of Virginia

Enrollment

770 participants

Start Date

Mar 6, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Levetiracetam (LEV) (60 mg/Kg), a drug called Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET), and others for people with status epilepticus. The study is currently recruiting participants at 52 locations. People eligible for this study include aged 1 Year and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLevetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET)

The study drug will be produced at the central pharmacy, a GMP facility at the University of California, Davis. Diluted formulations are expected to remain stable for months when stored at room temperature. Expiration dates for study drugs will be determined and adjusted based on ongoing stability testing performed on study drugs prepared at the GMP facility for the study. All three formulations will be transparent solutions. None of the formulations are reported to consistently cause adverse effects at the infusion site. The method of drug administration, including volume and rate of infusion, is identical for all three drugs. These factors ensure that drug administration will be blinded.

DRUGLevetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET)

The study drug will be produced at the central pharmacy, a GMP facility at the University of California, Davis. Diluted formulations are expected to remain stable for months when stored at room temperature. Expiration dates for study drugs will be determined and adjusted based on ongoing stability testing performed on study drugs prepared at the GMP facility for the study. All three formulations will be transparent solutions. None of the formulations are reported to consistently cause adverse effects at the infusion site. The method of drug administration, including volume and rate of infusion, is identical for all three drugs. These factors ensure that drug administration will be blinded.

DRUGLevetiracetam (LEV) (60 mg/Kg)

The study drug will be produced at the central pharmacy, a GMP facility at the University of California, Davis. Diluted formulations are expected to remain stable for months when stored at room temperature. Expiration dates for study drugs will be determined and adjusted based on ongoing stability testing performed on study drugs prepared at the GMP facility for the study. All three formulations will be transparent solutions. None of the formulations are reported to consistently cause adverse effects at the infusion site. The method of drug administration, including volume and rate of infusion, is identical for all three drugs. These factors ensure that drug administration will be blinded.


Locations(63)

UAB Hospital

Birmingham, Alabama, United States

Banner University Medical Center - Tucson Campus

Tucson, Arizona, United States

UC San Diego Health La Jolla

La Jolla, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Stanford University Medical Center

Palo Alto, California, United States

UC Davis Medical Center

Sacramento, California, United States

UC San Diego Health Hillcrest Hospital

San Diego, California, United States

Rady Children's Hospital

San Diego, California, United States

San Francisco General Hospital

San Francisco, California, United States

UCSF Medical Center

San Francisco, California, United States

Harbor-UCLA Medical Center

Torrance, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Christiana Hospital

Newark, Delaware, United States

Nemours Children's Hospital

Wilmington, Delaware, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Orlando Regional Medical Center

Orlando, Florida, United States

Grady Memorial Hospital

Atlanta, Georgia, United States

Arthur M. Blank Hospital

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Illinois Hospital

Chicago, Illinois, United States

Comer Children's Hospital

Chicago, Illinois, United States

University of Chicago Medical Center

Chicago, Illinois, United States

IU Health Methodist Hospital

Indianapolis, Indiana, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

University of Iowa Medical Center

Iowa City, Iowa, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan University Hospital

Ann Arbor, Michigan, United States

Detroit Receiving Hospital

Detroit, Michigan, United States

Sinai-Grace Hospital

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Cooper University Hospital

Camden, New Jersey, United States

University of New Mexico Hospital

Albuquerque, New Mexico, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Duke University Hospital

Durham, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

OSU Wexner Medical Center

Columbus, Ohio, United States

Oregon Health & Science University Hospital

Portland, Oregon, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Temple University Hospital Jeanes Campus

Philadelphia, Pennsylvania, United States

Temple University Hospital Main Campus

Philadelphia, Pennsylvania, United States

Jefferson Einstein Philadelphia Hospital

Philadelphia, Pennsylvania, United States

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Reading Hospital

West Reading, Pennsylvania, United States

Children's Medical Center Dallas

Dallas, Texas, United States

Memorial Hermann Texas Medical Center

Houston, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

University of Utah Healthcare

Salt Lake City, Utah, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

VCU Medical Center

Richmond, Virginia, United States

Harborview Medical Center

Seattle, Washington, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Froedtert Hospital

Milwaukee, Wisconsin, United States

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NCT06907173


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