Using low doses of IV Ketamine to treat drug resistant epilepsy

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

This study is testing if low doses of IV Ketamine can help people with drug-resistant epilepsy have fewer seizures and improve their mood.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT05019885 on ClinicalTrials.gov

What this trial studies

This open-label pilot study aims to evaluate the effectiveness of subanesthetic doses of intravenous Ketamine (0.5mg/kg) in patients suffering from drug resistant epilepsy. Participants will undergo a screening phase where they must document at least four seizures in 28 days, followed by a treatment phase consisting of six visits over two weeks where they will receive Ketamine infusions three times a week. Mood assessments will also be conducted to monitor any changes during the treatment. The study will include safety assessments post-treatment to evaluate any adverse effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of drug resistant epilepsy who have failed two or more anti-seizure medications.

Not a fit: Patients under 18 years of age, pregnant or breastfeeding women will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with drug resistant epilepsy who have not responded to traditional therapies.

How similar studies have performed: While Ketamine has shown promise in treating drug resistant depression, its use in outpatient settings for drug resistant epilepsy is novel and has not been extensively tested.

Eligibility criteria

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.)

Where this trial is running

New York, New York

• Mount Sinai Hospital — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Madeline Fields, MD — Icahn School of Medicine
• Study coordinator: Onome Eka, MBBS MPH

Conditions: Drug Resistant Epilepsy, Medically Refractory Epilepsy, Refractory Epilepsy, drug resistant epilepsy, subanesthetic Ketamine hydrochloride