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Ketamine for Drug-Resistant Epilepsy

This study is looking at whether intravenous (IV) ketamine, given at low doses, can help people with drug-resistant epilepsy. Ketamine is a medication used for anesthesia and pain, and recently approved for drug-resistant depression. This study will give ketamine three times a week for two weeks to see if it reduces seizures. You might be able to join if you are an adult (18 or older) with a diagnosis of drug-resistant epilepsy, meaning other seizure medications haven't worked well for you. The study will measure how much your seizures are reduced during treatment and up to three months afterward. The current status of this study is unclear.

Study design
This is an open-label pilot study, meaning everyone knows they are receiving ketamine. It plans to enroll 8 participants.
What's involved
You would track your seizures for four weeks, then receive IV ketamine three times a week for two weeks. There will also be five safety assessments and three post-treatment assessments.
Compensation
Not stated in the trial record.
Follow-up
Your seizure frequency will be measured at 28 days and three months after your last ketamine infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05019885

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Madeline Fields
~8 participants
Updated 2025-08-15 on ClinicalTrials.gov
What's tested:Ketamine Hydrochloride

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with seizure reduction
Measured over 2 week during active treatment
+2 more outcomes measured

Conditions

Drug Resistant Epilepsy
Medically Refractory Epilepsy
Refractory Epilepsy

Explore related trials

Seizure Disorder

Where it's being run

1 sites across 1 states
New York1

Study leadership

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

Who to contact

Onome Eka, MBBS MPH
[email protected]
212-241-8861 · ext. 48861
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.)

What this trial measures

  • Number of participants with seizure reduction2 week during active treatment

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

  • Number of participants with seizure reduction28 days post infusion

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

  • Seizure frequency3 months post infusion

    Return to pre-ketamine infusion seizure frequency in 3 months