Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
KESETT
1 other identifier
interventional
770
1 country
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2026
Typical duration for phase_3
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2025
CompletedFirst Posted
Study publicly available on registry
April 2, 2025
CompletedStudy Start
First participant enrolled
March 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
April 9, 2026
April 1, 2026
3.2 years
March 24, 2025
April 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Termination of SE
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.
From 15 minutes after starting the study drug infusion, sustained for 60 minutes without using additional anti-seizure medication.
Secondary Outcomes (8)
Desirability of response (DOOR) outcome
60 minutes after starting the study drug infusion
Endotracheal intubation
Within 60 minutes after start of the study drug infusion
ICU duration
Up to 30 days after enrollment
Hospital length-of-stay (LOS)
Up to 30 days after enrollment
Late recurrent seizure
Between 60 minutes and 4 hours after the start of the study drug infusion
- +3 more secondary outcomes
Study Arms (3)
Levetiracetam
ACTIVE COMPARATORLevetiracetam (LEV) (60 mg/Kg)
Levetiracetam + low dose Ketamine
EXPERIMENTALLEV 60 mg/mL + 1 mg/mL KET
Levetiracetam + high dose Ketamine
EXPERIMENTALLEV 60 mg/mL + 3 mg/mL KET increasing up to a weight of 75 kg
Interventions
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.
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.
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michigancollaborator
- Medical University of South Carolinacollaborator
- Massachusetts General Hospitalcollaborator
- Children's National Research Institutecollaborator
- University of Virginialead
Study Sites (47)
Banner University Medical Center - Tucson Campus
Tucson, Arizona, 85724, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90024, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
San Francisco General Hospital
San Francisco, California, 94143, United States
Yale New Haven Hospital
New Haven, Connecticut, 06519, United States
Christiana Hospital
Newark, Delaware, 19718, United States
Nemours Children's Hospital
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Orlando Regional Medical Center
Orlando, Florida, 32806, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Arthur M. Blank Hospital
Atlanta, Georgia, 30329, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Comer Children's Hospital
Chicago, Illinois, 60637, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Iowa Medical Center
Iowa City, Iowa, 52242, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan University Hospital
Ann Arbor, Michigan, 48109, United States
Detroit Receiving Hospital
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55414, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Duke Regional Hospital
Durham, North Carolina, 27710, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Oregon Health & Science University Hospital
Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Jefferson Einstein Philadelphia Hospital
Philadelphia, Pennsylvania, 19141, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030, United States
Primary Children's Hospital
Salt Lake City, Utah, 84108, United States
University of Utah Healthcare
Salt Lake City, Utah, 84112, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
VCU Medical Center
Richmond, Virginia, 23298, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaideep Kapur, MD, PhD
University of Virginia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Eugene Meyer III Professor of Neuroscience and Professor of Neurology
Study Record Dates
First Submitted
March 24, 2025
First Posted
April 2, 2025
Study Start
March 6, 2026
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The timeline of submission of the public use dataset to the repository will comply with all relevant repository guidelines but in general SIREN will submit data to the repository approximately one year after the primary manuscript of the trial is accepted for publication.
- Access Criteria
- Access to the de-identified dataset will be controlled by the data repository. DABI offers two approaches to data access: public or private. The KESETT team plans to make the de-identified data public which means it will be publicly available for downloading to DABI account holders.
The data will be stored in Data Archive for the Brain Initiative (DABI) after trial completion. Once submitted to the data repository, we will work with DABI support to ensure that the de-identified KESETT data is available to the public in the DABI search engine where data requests can be submitted.