RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pilot Study to Assess the Efficacy of Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy

Quick Facts

Study Start:2022-08-26
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05019885

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Adults (18 years or older)
  3. * Cognitively impaired adults are not excluded (i.e. will be included in the study)
  4. * Established diagnosis of Drug Resistant Epilepsy (DRE) i.e. failed two or more appropriately chosen anti-seizure medications (ASMs)
  5. * EEG consistent with focal or generalized epilepsy
  6. * Patients must have \>4 focal aware, focal impaired aware, focal to bilateral tonic clonic or generalized tonic clonic seizures per month.
  7. * Patients can be on \>/= 1 anti-seizure medication (ASM) at the time of enrollment on stable doses 12 weeks prior to initiation
  8. * Patients on Epilepsy devices: Vagal nerve stimulator (VNS), Deep brain stimulator (DBS) or Responsive Nerve Stimulator (RNS) must have remained stable for at least 4 weeks before the screening visit. Adjustment of devices is not allowed during the study.
  9. * Patients \<18 years of age
  10. * Pregnant women
  11. * Women that are breast feeding
  12. * Patients who had \>21 days of seizure freedom in the last year.
  13. * Patients with a history of status epilepticus within 3 months of screening
  14. * Patients with a history of alcoholism of drug misuse within the last 2 years
  15. * Unstable medical illness
  16. * Serious or imminent suicidal or homicidal risk
  17. * Patients with cardiovascular disease
  18. * Patients with schizophrenia
  19. * Patients with history of aneurysm or aortic dissection, arteriovenous malformation and intracerebral hemorrhage
  20. * Patients that are immobile i.e. wheel chair bound, bed ridden individuals
  21. * Patients on psychostimulants (amphetamines, methylphenidate etc.) and Monoamine oxidase inhibitors (selegiline, isocarboxazid, phenelzine etc.)
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Onome Eka, MBBS MPH
CONTACT
212-241-8861
onome.eka@mssm.edu

Principal Investigator

Madeline Fields, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine
Lara Marcuse, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine

Study Locations (Sites)

Mount Sinai Hospital
New York, New York, 10035
United States

Collaborators and Investigators

Sponsor: Madeline Fields

  • Madeline Fields, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine
  • Lara Marcuse, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-26
Study Completion Date2024-12

Study Record Updates

Study Start Date2022-08-26
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • drug resistant epilepsy
  • subanesthetic Ketamine hydrochloride

Additional Relevant MeSH Terms

  • Drug Resistant Epilepsy
  • Medically Refractory Epilepsy
  • Refractory Epilepsy