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AzTrials

Status EpilepticusPhase 3KESETTNCT06907173

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

A Phase 3 study testing Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET), Levetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET) and Levetiracetam (LEV) (60 mg/Kg) in people with Status Epilepticus, run by University of Virginia at 63 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year and older
Conditions the study is for
Status Epilepticus
What is being tested?
Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET), Levetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET) and Levetiracetam (LEV) (60 mg/Kg)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
770 participants
Where
63 sitesUnited States
Study dates
6 Mar 2026to Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

63 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Megan Wardius contact

434-243-6768

mew5j@virginia.edu

63 sites in 1 country

United States63 sites, 62 recruiting

  • University of New Mexico Hospital

    Albuquerque, New Mexico, 87106

    Masoom Desai, MD, 505-272-0356, MDesai@salud.unm.edu

    Masoom Desai, MD

    Not yet recruiting

  • University of Michigan University Hospital

    Ann Arbor, Michigan, 48109

    Mariama Runcie, MD, 734-232-2145, runciema@med.umich.edu

    Mariama Runcie, MD

    Recruiting

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

    Active, not recruiting

  • Arthur M. Blank Hospital

    Atlanta, Georgia, 30329

    Claudia Morris, MD, 404-785-7070, claudia.r.morris@emory.edu

    Claudia Morris, MD

    Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

    Jennifer Hopp, MD, 410-328-7635, jhopp@som.umaryland.edu

    Jennifer Hopp, MD

    Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

    Kathryn Rosenblatt, MD, 410-955-6488, krosenb3@jhmi.edu

    Kathryn Rosenblatt, MD

    Recruiting

  • UAB Hospital

    Birmingham, Alabama, 35233

    Lauren Walter, MD, MSPH, 205-996-4791, lwalter@uabmc.edu

    Lauren Walter, MD, MSPH

    Not yet recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Michael Filbin, MD, 617-724-4758, mfilbin@mgh.harvard.edu

    Michael Filbin, MD

    Not yet recruiting

  • Cooper University Hospital

    Camden, New Jersey, 08103

    Christopher Jones, MD, 856-342-2637, jones-christopher@cooperhealth.edu

    Christopher Jones, MD

    Not yet recruiting

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

    Thomas Hartka, MD, 434-924-2897, trh6u@uvahealth.org

    Thomas Hartka, MD

    Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Peter Pruitt, MD, 312-694-7000, peter.pruitt@nm.org

    Peter Pruitt, MD

    Not yet recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Michael Gottlieb, MD, MBA, 631-922-1705, Michael_A_Gottlieb@rush.edu

    Michael Gottlieb, MD, MBA

    Recruiting

  • University of Illinois Hospital

    Chicago, Illinois, 60612

    Pavitra Kotini-Shah, MD, 817-703-1723, pkotini@uic.edu

    Pavitra Kotini-Shah, MD

    Not yet recruiting

  • Comer Children's Hospital

    Chicago, Illinois, 60637

    David Beiser, MD, 773-834-4135, dbeiser@medicine.bsd.uchicago.edu

    David Beiser, MD

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    David Beiser, MD, 773-834-4135, dbeiser@medicine.bsd.uchicago.edu

    David Beiser, MD

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

    Jason McMullan, MD, 513-675-3072, jason.mcmullan@uc.edu

    Jason McMullan, MD

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Aarti Gaglani Aarti Gaglani, MD, 6147226910, kesett@nationwidechildrens.org

    Aarti Gaglani, MD

    Recruiting

  • OSU Wexner Medical Center

    Columbus, Ohio, 43210

    Kirstin Acus, MD, 614-293-6185, kirstin.acus@osumc.edu

    Kirstin Acus, MD

    Recruiting

  • Children's Medical Center Dallas

    Dallas, Texas, 75235

    Pamela Okada, MD, 214-456-7000 ext. 67102, pamela.okada@utsouthwestern.edu

    Pamela Okada, MD

    Not yet recruiting

  • Detroit Receiving Hospital

    Detroit, Michigan, 48201

    Wazim Mohamed, MD, 313-577-8824, wmohamed@med.wayne.edu

    Wazim Mohamed, MD

    Not yet recruiting

  • Sinai-Grace Hospital

    Detroit, Michigan, 48201

    Arun Sherma, MD, 313-745-4238, arun@sherma.org

    Arun Sherma, MD

    Not yet recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Joseph Miller, MD, 313-404-9110, jmiller6@hfhs.org

    Joseph Miller, MD

    Not yet recruiting

  • Duke University Hospital

    Durham, North Carolina, 27710

    Alexander Limkakeng, MD, 919-681-0908, alexander.limkakeng@duke.edu

    Alexander Limkakeng, MD

    Not yet recruiting

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

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

    Kayleigh Fischer, MD

    Recruiting

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

    Daniel Udrea, MD, 317-274-0829, dudrea@iu.edu

    Daniel Udrea, MD

    Recruiting

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

    Benjamin Nti, MD, 317-416-7997, bnti@iu.edu

    Benjamin Nti, MD

    Recruiting

  • University of Iowa Medical Center

    Iowa City, Iowa, 52242

    Brett Faine, MD, 319-384-5228, brett-faine@uiowa.edu

    Brett Faine, MD

    Recruiting

  • UC San Diego Health La Jolla

    La Jolla, California, 92037

    Vanessa Tamas, MD, 858-966-8033, vtamas@rchsd.org

    Vanessa Tamas, MD

    Not yet recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90024

    Richelle Cooper, MD, 424-440-0486, rcooper@mednet.ucla.edu

    Richelle Cooper, MD

    Not yet recruiting

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

    Ara Festekjian, MD, 323-804-8142, afestekjian@chla.usc.edu

    Ara Festekjian, MD

    Not yet recruiting

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

    Keli Coleman, MD, 414-266-2767, kcoleman@mcw.edu

    Keli Coleman, MD

    Recruiting

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226

    Jamie Jasti, MD, 414-805-6493, jjasti@mcw.edu

    Jamie Jasti, MD

    Recruiting

  • University of Minnesota Masonic Children's Hospital

    Minneapolis, Minnesota, 55414

    James Miner, MD, 612-624-7426, miner015@umn.edu

    James Miner, MD

    Recruiting

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

    Brian Driver, MD, 612-873-7448, brian.driver@hcmed.org

    Brian Driver, MD

    Not yet recruiting

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

    James Miner, MD, 612-624-7426, miner015@umn.edu

    James Miner, MD

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 06519

    Charles Wira, MD, 203-785-5781, charles.wira@yale.edu

    Charles Wira, MD

    Recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Stephen Lim, MD, 504-702-2440, slim@lsuhsc.edu

    Stephen Lim, MD

    Not yet recruiting

  • Christiana Hospital

    Newark, Delaware, 19718

    Jason Nomura, MD, 302-733-4113, jnomura@christianacare.org

    Jason Nomura, MD

    Not yet recruiting

  • Orlando Regional Medical Center

    Orlando, Florida, 32806

    Dipali Nemade, MD, 321-841-1324, Dipali.Nemade@orlandohealth.com

    Dipali Nemade, MD

    Recruiting

  • Stanford University Medical Center

    Palo Alto, California, 94304

    Alexandra June Gordon, MD, 650-248-7701, ajgordon@stanford.edu

    Alexandra June Gordon, MD

    Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    John Greenwood, MD, 267-252-8741, john.greenwood@pennmedicine.upenn.edu

    John Greenwood, MD

    Not yet recruiting

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

    John Greenwood, MD, 267-252-8741, john.greenwood@pennmedicine.upenn.edu

    John Greenwood, MD

    Not yet recruiting

  • Temple University Hospital Jeanes Campus

    Philadelphia, Pennsylvania, 19111

    Derek Isenberg, MD, 215-707-0222, derek.isenberg@tuhs.temple.edu

    Derek Isenberg, MD

    Recruiting

  • Temple University Hospital Main Campus

    Philadelphia, Pennsylvania, 19140

    Derek Isenberg, MD, 215-707-0222, derek.isenberg@tuhs.temple.edu

    Derek Isenberg, MD

    Recruiting

  • Jefferson Einstein Philadelphia Hospital

    Philadelphia, Pennsylvania, 19141

    Joseph Herres, DO, 215-457-5865, Joseph.herres@jefferson.edu

    Joseph Herres, DO

    Recruiting

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

    Adam Frisch, MD, 412-647-9047, frischan@upmc.edu

    Adam Frisch, MD

    Recruiting

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

    Robert Hickey, MD, 412-692-6567, robert.hickey@chp.edu

    Robert Hickey, MD

    Recruiting

  • Oregon Health & Science University Hospital

    Portland, Oregon, 97239

    Bory Kea, MD, 503-494-8083, kea@ohsu.edu

    Bory Kea, MD

    Recruiting

  • VCU Medical Center

    Richmond, Virginia, 23298

    Lisa Merck, MD, MPH, MHA, 862-383-1688, Lisa.Merck@vcuhealth.org

    Lisa Merck, MD, MPH, MHA

    Not yet recruiting

  • UC Davis Medical Center

    Sacramento, California, 95817

    Daniel Nishijima, MD, 916-734-5010, dnishijima@ucdavis.edu

    Daniel Nishijima, MD

    Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utah, 84108

    Maija Holsti, MD, MPH, 801-656-8833, Maija.Holsti@hsc.utah.edu

    Maija Holsti, MD, MPH

    Not yet recruiting

  • University of Utah Healthcare

    Salt Lake City, Utah, 84112

    Scott Youngquist, MD, 801-349-0241, scott.youngquist@utah.edu

    Scott Youngquist, MD

    Not yet recruiting

  • UC San Diego Health Hillcrest Hospital

    San Diego, California, 92103

    Vanessa Tamas, MD, 858-966-8033, vtamas@rchsd.org

    Vanessa Tamas, MD

    Not yet recruiting

  • Rady Children's Hospital

    San Diego, California, 92123

    Vanessa Tamas, MD, 858-966-8033, vtamas@rchsd.org

    Vanessa Tamas, MD

    Not yet recruiting

  • San Francisco General Hospital

    San Francisco, California, 94143

    Debbie Madhok, MD, 415-601-6399, Debbie.madhok@ucsf.edu

    Debbie Madhok, MD

    Recruiting

  • UCSF Medical Center

    San Francisco, California, 94143

    Debbie Madhok, MD, 415-601-6399, Debbie.madhok@ucsf.edu

    Debbie Madhok, MD

    Recruiting

  • Harborview Medical Center

    Seattle, Washington, 98104

    Vasisht Srinivasan, MD, 585-730-3843, vasishts@uw.edu

    Vasisht Srinivasan, MD

    Recruiting

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

    Lindsay Nausin, DO, 315-464-4363, nausinl@upstate.edu

    Lindsay Nausin, DO

    Not yet recruiting

  • Harbor-UCLA Medical Center

    Torrance, California, 90502

    Juliana Tolles, MD, 434-243-6768, jtolles@emedharbor.edu

    Juliana Tolles, MD

    Not yet recruiting

  • Banner University Medical Center - Tucson Campus

    Tucson, Arizona, 85724

    Aaron Leetch, MD, 520-621-8752, aleetch@arizona.edu

    Aaron Leetch, MD

    Recruiting

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

    James Chamberlain, MD, 202-476-8877, jchamber@childrensnational.org

    James Chamberlain, MD

    Recruiting

  • Reading Hospital

    West Reading, Pennsylvania, 19611

    Adam Sigal, MD, 484-628-7016, adam.sigal@towerhealth.org

    Adam Sigal, MD

    Recruiting

  • Nemours Children's Hospital

    Wilmington, Delaware, 19803

    Amy Thompson, MD, 302-490-4146, amy.thompson@nemours.org

    Amy Thompson, MD

    Recruiting

Other trials in United States

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.

Read the detailed description

KESETT is a multicenter, randomized, blinded study to determine whether adding 1 mg/kg or 3 mg/kg dose of KET to 60 mg/kg LEV can terminate status epilepticus (SE) in a larger fraction of subjects with benzodiazepine-refractory SE than those treated with LEV (60 mg/kg) alone.

The primary outcome is termination of SE from 15 minutes after starting the study drug infusion, sustained until 60 minutes from enrollment 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 SE after 15 minutes in those with EEG monitoring and no improvement in consciousness.

Secondary objectives include determining the relative safety of the treatment arms on defined safety outcomes and all adverse events, analysis of secondary/exploratory efficacy outcomes, and evaluation of both effectiveness and safety in the pediatric subpopulation.

The trial will initially allocate subjects equally (1:1:1) for the first 350 participants (burn-in period) before transitioning to response-adaptive randomization. Interim analyses will be conducted for efficacy and futility beginning when 350 subjects have been randomized, and will occur every 100 subjects thereafter. A maximum of 770 participants will be enrolled.

Being 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)
Medical subject headings
Status Epilepticus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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)Drug

    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)Drug

    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.

Study groups in NCT06907173
Study groupRoleWhat they receive
LevetiracetamActive comparatorLevetiracetam (LEV) (60 mg/Kg)
Receives: Drug: Levetiracetam (LEV) (60 mg/Kg)
Levetiracetam + low dose KetamineExperimentalLEV 60 mg/mL + 1 mg/mL KET
Receives: Drug: Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET)
Levetiracetam + high dose KetamineExperimentalLEV 60 mg/mL + 3 mg/mL KET increasing up to a weight of 75 kg
Receives: Drug: Levetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From 15 minutes after starting the study drug infusion, sustained for 60 minutes without using additional anti-seizure medication.

Secondary outcomes (8)

  1. Desirability of response (DOOR) outcome

    One secondary outcome will be a desirability of response (DOOR) outcome which is a composite efficacy measure evaluated on a graded scale from 1 to 5 at 60 minutes, as follows:

    • No clinically evident or electrographic seizures after 15 minutes, no rescue drugs, and improving mental status by 60 minutes
    • No clinically evident or electrographic seizures after 15 minutes, not intubated, but not improving mental status at 60 minutes
    • No clinically evident or electrographic seizures after 15 minutes, but intubated or use of additional seizures medications (including medications used for intubation)
    • Any clinically evident seizure or electrographic seizure requiring rescue medicine within the timeframe between 15 and 60 minutes
    • Life-threatening hypotension or cardiac arrhythmia or death within 60 minutes

    The Central Adjudication Core will determine the DOOR grade (1-5) based on clinical outcome data provided by the site and EEG data provided by the Central EEG Core.

    Measured: 60 minutes after starting the study drug infusion

  2. Endotracheal intubation

    Endotracheal intubation within 60 minutes of randomization (start of study drug infusion) and duration

    Measured: Within 60 minutes after start of the study drug infusion

  3. ICU duration

    ICU duration during the study period for those that are admitted to the ICU as abstracted from the hospital admission record

    Measured: Up to 30 days after enrollment

  4. Hospital length-of-stay (LOS)

    Hospital length-of-stay (LOS) from the ED as abstracted from the hospital admission record

    Measured: Up to 30 days after enrollment

  5. Late recurrent seizure

    Number of participants with late recurrent seizure between 60 minutes and 4 hours after the start of the study drug infusion

    Measured: Between 60 minutes and 4 hours after the start of the study drug infusion

  6. Time to termination of seizures

    The interval from the start of infusion of study drug to the cessation of electrographic seizure in those who meet the primary outcome

    Measured: From the start of infusion of study drug to the cessation of electrographic seizure assessed up to 60 minutes from study drug initiation

  7. Late seizures after requiring an anesthetic

    Number of participants with late seizures after requiring an anesthetic between 60 minutes and 24 hours after start of study drug infusion

    Measured: Between 60 minutes and 24 hours after start of study drug infusion

  8. All cause mortality

    All cause mortality to end of study

    Measured: From the start of study drug infusion to hospital discharge or day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2025
  2. Study start6 Mar 2026
  3. Primary completionJun 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
770 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06907173
Sponsor's protocol ID
HSR231657
Acronym
KESETT
Status last verified
Apr 2026
First submitted
24 Mar 2025
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET), Levetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET) and Levetiracetam (LEV) (60 mg/Kg) in people with Status Epilepticus, run by University of Virginia at 63 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Megan Wardius (434-243-6768, mew5j@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06907173.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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