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

Conditions

• Status Epilepticus

Eligibility Criteria

Sex

ALL

Age

1 Year - N/A

Healthy Volunteers

Not accepted

Interventions

• Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET) — DRUG
  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.
• Levetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET) — DRUG
  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.
• Levetiracetam (LEV) (60 mg/Kg) — DRUG
  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.

Study Details

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.

Key Dates

Start date

Mar 6, 2026

Status verified

Apr 2026

Primary completion

Jun 30, 2029

Completion

Dec 31, 2029

Study Design

Enrollment

770 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Levetiracetam
  Levetiracetam (LEV) (60 mg/Kg)
• Experimental: Levetiracetam + low dose Ketamine
  LEV 60 mg/mL + 1 mg/mL KET
• Experimental: Levetiracetam + high dose Ketamine
  LEV 60 mg/mL + 3 mg/mL KET increasing up to a weight of 75 kg

Primary Outcome Measure

Termination of SE [ Time Frame: From 15 minutes after starting the study drug infusion, sustained for 60 minutes without using additional anti-seizure medication. ]

Central Contacts

• Megan Wardius
  434-243-6768
  [email protected]

Locations (52)

Find similar trials in Tucson, AZ

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