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

Study Details

Brief 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.

Conditions

Status Epilepticus

Study ID

NCT06907173

Start date

Mar 6, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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 Design

Enrollment

770 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

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.

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.

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 measure

Termination of SE [ Time Frame: From 15 minutes after starting the study drug infusion, sustained for 60 minutes without using additional anti-seizure medication. ]

Central Contacts and Locations

Central contacts

Megan Wardius

434-243-6768 mew5j@virginia.edu

Locations

Banner University Medical Center - Tucson Campus

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Aaron Leetch, MD

520-621-8752 aleetch@arizona.edu

Principal Investigator:

Aaron Leetch, MD

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Daniel Nishijima, MD

916-734-5010 dnishijima@ucdavis.edu

Principal Investigator:

Daniel Nishijima, MD

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Charles Wira, MD

203-785-5781 charles.wira@yale.edu

Principal Investigator:

Charles Wira, MD

Children's National Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

James Chamberlain, MD

202-476-8877 jchamber@childrensnational.org

Principal Investigator:

James Chamberlain, MD

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Jonathan Ratcliff, MD, MPH

404-778-1762 jonathan.ratcliff@emoryhealthcare.org

Principal Investigator:

Jonathan Ratcliff, MD, MPH

Arthur M. Blank Hospital

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Claudia Morris, MD

404-785-7070 claudia.r.morris@emory.edu

Principal Investigator:

Claudia Morris, MD

University of Michigan University Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Mariama Runcie, MD

734-232-2145 runciema@med.umich.edu

Principal Investigator:

Mariama Runcie, MD

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Aarti Gaglani Aarti Gaglani, MD

6147226910 kesett@nationwidechildrens.org

Principal Investigator:

Aarti Gaglani, MD

Oregon Health & Science University Hospital

Recruiting

Portland, Oregon, United States, 97239

Contacts

Bory Kea, MD

503-494-8083 kea@ohsu.edu

Principal Investigator:

Bory Kea, MD

Temple University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Derek Isenberg, MD

215-707-0222 derek.isenberg@tuhs.temple.edu

Principal Investigator:

Derek Isenberg, MD

UPMC Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Robert Hickey, MD

412-692-6567 robert.hickey@chp.edu

Principal Investigator:

Robert Hickey, MD

Reading Hospital

Recruiting

West Reading, Pennsylvania, United States, 19611

Contacts

Adam Sigal, MD

484-628-7016 adam.sigal@towerhealth.org

Principal Investigator:

Adam Sigal, MD

Memorial Hermann Texas Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Kayleigh Fischer, MD

713-500-7803 Kayleigh.A.Fischer@uth.tmc.edu

Principal Investigator:

Kayleigh Fischer, MD

University of Virginia Medical Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Thomas Hartka, MD

434-924-2897 trh6u@uvahealth.org

Principal Investigator:

Thomas Hartka, MD

Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Vasisht Srinivasan, MD

585-730-3843 vasishts@uw.edu

Principal Investigator:

Vasisht Srinivasan, MD

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

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information