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Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
RecruitingPhase 3
Who can join
Ages 1 and older · All sexes
Full eligibility 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
About the 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.
What is being tested
- Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET) (drug)
- Levetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET) (drug)
- Levetiracetam (LEV) (60 mg/Kg) (drug)
Sponsor: University of Virginia · Participants: 770 · Started: Mar 6, 2026
Contact the study team
- Megan Wardius · Phone: 434-243-6768
Official record on ClinicalTrials.gov — NCT06907173
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.