Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05019885

The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy

Led by Madeline Fields · Updated on 2025-08-15

8

Participants Needed

1

Research Sites

183 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Ketamine is a medication that came into clinical practice in the 1960's. Ketamine is used as an anesthetic and to provide pain relief. Recently, Ketamine was approved to treat drug resistant depression using subanesthetic doses. In the hospital setting, intravenous anesthetic dosages are used to treat unrelenting seizures known as status epilepticus in comatose patients. Ketamine in subanesthetic doses has not been tried as a treatment for medication resistant seizures in the outpatient setting. This study would like to examine the effectiveness of subanesthetic ketamine in outpatients who suffer from drug resistant epilepsy.

CONDITIONS

Official Title

The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form provided
  • Adults aged 18 years or older
  • Cognitively impaired adults are eligible
  • Diagnosed with drug resistant epilepsy after failing two or more anti-seizure medications
  • EEG confirming focal or generalized epilepsy
  • At least 4 seizures per month (focal aware, focal impaired aware, focal to bilateral tonic clonic, or generalized tonic clonic)
  • On one or more stable anti-seizure medications for at least 12 weeks before starting
  • Stable epilepsy devices (VNS, DBS, RNS) for at least 4 weeks before screening; no adjustments allowed during study
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Pregnant or breastfeeding women
  • More than 21 days seizure-free in the last year
  • History of status epilepticus within 3 months before screening
  • History of alcoholism or drug misuse within the last 2 years
  • Unstable medical illness
  • Serious or imminent suicidal or homicidal risk
  • Cardiovascular disease
  • Schizophrenia
  • History of aneurysm, aortic dissection, arteriovenous malformation, or intracerebral hemorrhage
  • Immobile (wheelchair bound or bedridden)
  • Use of psychostimulants or monoamine oxidase inhibitors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Mount Sinai Hospital

New York, New York, United States, 10035

Actively Recruiting

Loading map...

Research Team

O

Onome Eka, MBBS MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here