NCT06907173 Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
| NCT ID | NCT06907173 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Virginia |
| Condition | Status Epilepticus |
| Study Type | INTERVENTIONAL |
| Enrollment | 770 participants |
| Start Date | 2026-03-06 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 770 participants in total. It began in 2026-03-06 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Jaideep Kapur, MD, PhD
PRINCIPAL INVESTIGATOR
University of Virginia
Frequently Asked Questions
Who can join the NCT06907173 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, studying Status Epilepticus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06907173 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 770 participants.
Is NCT06907173 currently recruiting?
Yes, NCT06907173 is actively recruiting participants. Contact the research team at mew5j@virginia.edu for enrollment information.
Where is the NCT06907173 trial being conducted?
This trial is being conducted at Birmingham, United States, Tucson, United States, La Jolla, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT06907173 clinical trial?
NCT06907173 is sponsored by University of Virginia. The principal investigator is Jaideep Kapur, MD, PhD at University of Virginia. The trial plans to enroll 770 participants.