NCT06907173 · University of Virginia
Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
(KESETT)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Levetiracetam (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.
DRUG
Levetiracetam (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.
DRUG
Levetiracetam (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.
Primary outcome measures
Termination of SE
Time frame: From 15 minutes after starting the study drug infusion, sustained for 60 minutes without using additional anti-seizure medication.
Termination of SE from 15 minutes after starting the study drug infusion, sustained for 60 minutes without using additional anti-seizure medication. Termination of SE is determined by (1) improving consciousness and absence of clinically apparent seizures at 60 minutes or (2) absence of any electrographic status epilepticus (ESE) after 15 minutes in those with EEG monitoring and no improvement in consciousness.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Tucson, Arizona
- Los Angeles, California
- Palo Alto, California
- Sacramento, California
- San Francisco, California
- New Haven, Connecticut
- Newark, Delaware
- Wilmington, Delaware
- Washington D.C., District of Columbia
- Orlando, Florida
- Atlanta, Georgia
- Chicago, Illinois
And 22 more locations — see the full list below.
Collaborators
University of Michigan, Medical University of South Carolina, Massachusetts General Hospital, Children's National Research Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations