NCT05019885CompletedPhase 2
The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy
A Pilot Study to Assess the Efficacy of Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 18 Aug 2021
- Start date
- 26 Aug 2022
- Primary completion date
- 8 Jun 2026
- Lead sponsor
- Madeline Fields
- Diseases
- Epilepsy
- NCT number
- NCT05019885
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 12
- From 26 Aug 2022 to the primary completion date, 8 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients on psychostimulants (amphetamines, methylphenidate etc.) and Monoamine oxidase inhibitors (selegiline, isocarboxazid, phenelzine etc.)
Other illness
- 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
- Patients with cardiovascular disease
- Patients with history of aneurysm or aortic dissection, arteriovenous malformation and intracerebral hemorrhage
Age
- Patients \<18 years of age
Other
- Pregnant women
- Women that are breast feeding
- Serious or imminent suicidal or homicidal risk
- Patients with schizophrenia
- Patients that are immobile i.e. wheel chair bound, bed ridden individuals
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.