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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

770

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

June 30, 2029

Study Completion Date

December 31, 2029

Conditions
Status Epilepticus
Interventions
DRUG

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

"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."

DRUG

Levetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET)

"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."

DRUG

Levetiracetam (LEV) (60 mg/Kg)

"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."

All Listed Sponsors
collaborator

University of Michigan

OTHER

collaborator

Medical University of South Carolina

OTHER

collaborator

Massachusetts General Hospital

OTHER

collaborator

Children's National Research Institute

OTHER

lead

University of Virginia

OTHER