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

Recruiting now · Phase 3

Conditions studied: Status Epilepticus

In brief

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.

Key facts

Study ID

NCT06907173

Run by

University of Virginia

People needed

770

Starts

2026-03-06

Expected to finish

2029-12-01

Last updated by the study team

2026-05-14

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Known pregnancy
• Prisoner
• Opt-out identification or otherwise known to be previously enrolled in KESETT
• 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 for this episode of SE(propofol, etomidate, ketamine or other agents defined in the MoP)
• Endotracheal intubation prior to enrollment
• Acute traumatic brain injury clearly precedes seizures
• Scalp injury or burn preventing EEG placement
• Known allergy or other known contraindication to KET or LEV
• Hypoglycemia < 50 mg/dL
• Hyperglycemia > 400 mg/dL
• Cardiac arrest / post-anoxic seizures

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• Reading Hospital — West Reading, Pennsylvania, United States (enrolling)
• University of Michigan University Hospital — Ann Arbor, Michigan, United States (enrolling)
• UC Davis Medical Center — Sacramento, California, United States (enrolling)
• Banner University Medical Center - Tucson Campus — Tucson, Arizona, United States (enrolling)
• Oregon Health & Science University Hospital — Portland, Oregon, United States (enrolling)
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
• University of Virginia Medical Center — Charlottesville, Virginia, United States (enrolling)
• Harborview Medical Center — Seattle, Washington, United States (enrolling)
• Memorial Hermann Texas Medical Center — Houston, Texas, United States (enrolling)
• Grady Memorial Hospital — Atlanta, Georgia, United States (enrolling)
• Arthur M. Blank Hospital — Atlanta, Georgia, United States (enrolling)
• Temple University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
• Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• UCSF Medical Center — San Francisco, California, United States
• Orlando Regional Medical Center — Orlando, Florida, United States
• San Francisco General Hospital — San Francisco, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Detroit Receiving Hospital — Detroit, Michigan, United States
• Sinai-Grace Hospital — Detroit, Michigan, United States
• University of Iowa Medical Center — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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