Status:
NOT_YET_RECRUITING
Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
University of Michigan
Medical University of South Carolina
Conditions:
Status Epilepticus
Eligibility:
All Genders
1+ years
Phase:
PHASE3
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.
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 wit...
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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
770 Patients enrolled
Trial Details
Trial ID
NCT06907173
Start Date
August 1 2025
End Date
December 1 2029
Last Update
April 2 2025
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