Recruiting
Phase 2

Ketamine

Sponsor:

Madeline Fields

Code:

NCT05019885

Conditions

Drug Resistant Epilepsy

Medically Refractory Epilepsy

Refractory Epilepsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ketamine Hydrochloride

Study Details

Brief summary:

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

Drug Resistant Epilepsy

Medically Refractory Epilepsy

Refractory Epilepsy

Study ID

NCT05019885

Start date

Aug 26, 2022

Status verified date

Aug, 2025

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Adults (18 years or older)
  • Cognitively impaired adults are not excluded (i.e. will be included in the study)
  • Established diagnosis of Drug Resistant Epilepsy (DRE) i.e. failed two or more appropriately chosen anti-seizure medications (ASMs)
  • EEG consistent with focal or generalized epilepsy
  • Patients must have >4 focal aware, focal impaired aware, focal to bilateral tonic clonic or generalized tonic clonic seizures per month.
  • Patients can be on >/= 1 anti-seizure medication (ASM) at the time of enrollment on stable doses 12 weeks prior to initiation
  • 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.

Exclusion Criteria

  • Patients <18 years of age
  • Pregnant women
  • Women that are breast feeding
  • Patients who had >21 days of seizure freedom in the last year.
  • Patients with a history of status epilepticus within 3 months of screening
  • Patients with a history of alcoholism of drug misuse within the last 2 years
  • Unstable medical illness
  • Serious or imminent suicidal or homicidal risk
  • Patients with cardiovascular disease
  • Patients with schizophrenia
  • Patients with history of aneurysm or aortic dissection, arteriovenous malformation and intracerebral hemorrhage
  • Patients that are immobile i.e. wheel chair bound, bed ridden individuals
  • Patients on psychostimulants (amphetamines, methylphenidate etc.) and Monoamine oxidase inhibitors (selegiline, isocarboxazid, phenelzine etc.)

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IV Ketamine Hydrochloride

dose 0.5mg/kg of IV Ketamine Hydrochloride over 40 min

Interventions

Ketamine Hydrochloride

Three times a week (M, W, F) for 2 consecutive weeks.

Primary outcome measure

  • Number of participants with seizure reduction [ Time Frame: 2 week during active treatment ]
  • Number of participants with seizure reduction [ Time Frame: 28 days post infusion ]
  • Seizure frequency [ Time Frame: 3 months post infusion ]

Central Contacts and Locations

Central contacts

Onome Eka, MBBS MPH

212-241-8861onome.eka@mssm.edu

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10035

Contacts

Onome Eka, MBBS MPH

9179825055onome.eka@mssm.edu

Principal Investigator:

Madeline Fields

More Information

Sponsor

Madeline Fields

Last update posted

Aug 15, 2025

Last verified

Aug, 2025

Keywords

  • drug resistant epilepsy
  • subanesthetic Ketamine hydrochloride

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Madeline Fields on 2025-08-15.