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

Who is this study for? Patients with Epilepsy
What treatments are being studied? Ketamine Hydrochloride
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
Mount Sinai Hospital
RECRUITING
New York
Contact Information
Primary
Onome Eka, MBBS MPH
onome.eka@mssm.edu
212-241-8861
Time Frame
Start Date: 2022-08-26
Estimated Completion Date: 2026-03
Participants
Target number of participants: 8
Treatments
Experimental: IV Ketamine Hydrochloride
dose 0.5mg/kg of IV Ketamine Hydrochloride over 40 min
Related Therapeutic Areas
Sponsors
Leads: Madeline Fields

This content was sourced from clinicaltrials.gov