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

NCT05019885 | Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY-20-01911
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

drug resistant epilepsy; subanesthetic Ketamine hydrochloride

Outcome Measures

Primary Outcomes (3)

• Number of participants with seizure reduction

  50% seizure reduction during the 2 week period of active treatment

  2 week during active treatment

• Number of participants with seizure reduction

  50% seizure reduction during the 28 days post-infusion.

  28 days post infusion

• Seizure frequency

  Return to pre-ketamine infusion seizure frequency in 3 months

  3 months post infusion

Secondary Outcomes (12)

• Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score

  Week 6

• Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score

  Week 10

• Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score

  Week 14

• Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score

  Week 18

• Quality of Life in Epilepsy (QOLIE-10)

  Week 6

Study Arms (1)

IV Ketamine Hydrochloride

EXPERIMENTAL

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

Drug: Ketamine Hydrochloride

Interventions

Ketamine Hydrochloride DRUG

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

IV Ketamine Hydrochloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Madeline Fields: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10035, United States

RECRUITING

Related Publications (37)

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MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Madeline Fields, MD

  Icahn School of Medicine

  PRINCIPAL INVESTIGATOR

• Lara Marcuse, MD

  Icahn School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Onome Eka, MBBS MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Neurology Co-Director Mount Sinai Epilepsy Center

Model Details: Experimental clinical treatment

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 25, 2021
• Study Start: August 26, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)