RecruitingPhase 3ketamine

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

Sponsored by University of Virginia

NCT ID
NCT06907173
Target Enrollment
770 participants
Start Date
2026-02
Est. Completion
2029-12

About This Study

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.

Conditions Studied

Status Epilepticus

Interventions

  • Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET)
  • Levetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET)
  • Levetiracetam (LEV) (60 mg/Kg)

Eligibility

Age:1 Year - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Study Locations (31)

Arthur M. Blank Hospital
Georgia, Alabama, United States
Banner University Medical Center - Tucson Campus
Tucson, Arizona, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, 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

+21 more locations

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Megan Wardius
CONTACT
434-243-6768mew5j@virginia.edu
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source