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

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.

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.

Sponsors & Collaborators

• University of Michigan

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Children's National Research Institute

  collaborator OTHER

• University of Virginia

  lead OTHER

Principal Investigators

• Jaideep Kapur, MD, PhD · University of Virginia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-06

Primary Completion

2029-06-30

Completion

2029-12-31

FDA Drug

Yes

Countries

• United States

Study Locations