NCT05019885 The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy
| NCT ID | NCT05019885 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Madeline Fields |
| Condition | Drug Resistant Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2022-08-26 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 8 participants in total. It began in 2022-08-26 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.)
Contact & Investigator
Madeline Fields, MD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine
Frequently Asked Questions
Who can join the NCT05019885 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Drug Resistant Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05019885 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05019885 currently recruiting?
Yes, NCT05019885 is actively recruiting participants. Contact the research team at onome.eka@mssm.edu for enrollment information.
Where is the NCT05019885 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05019885 clinical trial?
NCT05019885 is sponsored by Madeline Fields. The principal investigator is Madeline Fields, MD at Icahn School of Medicine. The trial plans to enroll 8 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.