Ketamine + Levetiracetam for Status Epilepticus

(KESETT Trial)

Not yet recruiting at 27 trial locations
MW
Overseen ByMegan Wardius
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Virginia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

JK

Jaideep Kapur, MD, PhD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

The KESETT trial is for patients who've had a convulsive seizure lasting over 5 minutes and are still having seizures after getting benzodiazepines. They must be at least 1 year old, weigh more than 10 kg, and have received their last dose of benzodiazepine within the past 5-30 minutes.

Inclusion Criteria

I am at least 1 year old.
I had a seizure that lasted more than 5 minutes and someone saw it happen.
I have taken the full prescribed dose of benzodiazepines.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Ketamine

Trial Overview

This study tests if adding ketamine to levetiracetam helps control status epilepticus better. Patients will either get levetiracetam with a low or high dose of ketamine, or just levetiracetam alone.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Levetiracetam + low dose KetamineExperimental Treatment1 Intervention
Group II: Levetiracetam + high dose KetamineExperimental Treatment1 Intervention
Group III: LevetiracetamActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+

Medical University of South Carolina

Collaborator

Trials
994
Recruited
7,408,000+

Children's National Research Institute

Collaborator

Trials
227
Recruited
258,000+