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Ketamine Add-on Therapy for Status Epilepticus (KESETT)

This study, called KESETT, is testing if adding ketamine to levetiracetam (LEV) can better stop ongoing seizures (status epilepticus) compared to levetiracetam alone. Researchers are comparing two different doses of ketamine (1 mg/kg or 3 mg/kg) along with levetiracetam (60 mg/kg) to just levetiracetam (60 mg/kg). The main goal is to see if seizures stop within 15 minutes of starting the study medicine and stay stopped for 60 minutes without needing more seizure medication. You might be able to join if you are at least 1 year old, have had a seizure lasting more than 5 minutes, received benzodiazepine medication, and are still having seizures in the emergency department. The study plans to enroll up to 770 participants, but its current recruitment status is unclear.

Study design
This is a multicenter, randomized, and blinded study, meaning participants are randomly assigned to a treatment group and neither you nor your doctors will know which treatment you are receiving. It aims to enroll up to 770 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured for 60 minutes after starting the study drug infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06907173

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

Recruiting
PHASE3Ages 1+InterventionalTreatment
University of Virginia
~770 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested: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)

At a glance

Recruiting sites
15 of 52 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Termination of SE
Measured over From 15 minutes after starting the study drug infusion, sustained for 60 minutes without using additional anti-seizure medication.

Conditions

Status Epilepticus

Explore related trials

Status Epilepticus

Where it's being run

52 sites across 24 states
Pennsylvania7
California6
Michigan4
Illinois3
Minnesota3
Ohio3
Delaware2
Georgia2

Study leadership

  • Jaideep Kapur, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Megan Wardius
[email protected]
434-243-6768
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Termination of SEFrom 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.