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Ketamine added to levetiracetam to stop prolonged convulsive seizures

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

Phase 3 Interventional University of Virginia · NCT06907173

This trial will test whether giving ketamine (two different doses) along with levetiracetam helps stop benzodiazepine-refractory status epilepticus in people age 1 and older.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment770 (estimated)
Ages1 Year and up
SexAll
SponsorUniversity of Virginia Academic / other
Locations51 sites (Tucson, Arizona and 50 other locations)
Trial IDNCT06907173 on ClinicalTrials.gov

What this trial studies

KESETT is a multicenter, randomized, blinded Phase 3 trial comparing levetiracetam alone (60 mg/kg) to levetiracetam plus ketamine at 1 mg/kg or 3 mg/kg in patients with convulsive seizures that continued after benzodiazepines. The primary outcome is stopping status epilepticus from 15 minutes after the start of the study infusion and keeping it stopped through 60 minutes without additional antiseizure drugs, determined by clinical improvement or EEG when available. The trial uses an initial 1:1:1 allocation for the first 350 participants then switches to response-adaptive randomization, with interim analyses for efficacy and futility and a maximum enrollment of 770 subjects. Safety outcomes, adverse events, and pediatric-specific effectiveness and safety are secondary objectives.

Who should consider this trial

Good fit: Ideal candidates are people age 1 year and older (≥10 kg) who had a witnessed convulsive seizure lasting more than 5 minutes, received adequate benzodiazepines 5–30 minutes before enrollment, and continue to have seizures in the emergency department.

Not a fit: Patients who already received second-line anticonvulsants or sedative agents for this episode, were intubated prior to enrollment, are pregnant, prisoners, or have acute traumatic brain injury preceding the seizures are not eligible and would not be expected to benefit from joining this trial.

Why it matters

Potential benefit: If successful, this approach could increase the chance of stopping prolonged seizures faster and reduce the need for more sedating second-line treatments or intubation.

How similar studies have performed: Smaller observational studies and case series have suggested ketamine can help in refractory status epilepticus, but randomized phase 3 evidence is limited, so this approach remains incompletely proven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Tucson, Arizona and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Status Epilepticus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.