The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy
NCT ID: NCT05019885
Last Updated: 2025-08-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
8 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-08-26
Study Completion Date
2026-03-31
Brief Summary
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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.
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Detailed Description
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This is an open label pilot study that will evaluate the effectiveness of a sub-anaesthetic dose (0.5mg/kg) of IV Ketamine in Drug Resistant Epilepsy Patients. Mood assessments will also be administered. The study consists of 3 phases:
Screening : Seizure diary will be prospectively filled for 4 weeks and subjects must have at least 4 seizures in 28 days to proceed to the treatment phase. Baseline mood assessment will be performed (NDDI-E, QOLIE-10, GAD 7 )
Treatment Phase: This phase will consist of 6 study visits (3 visits/ week for 2 weeks). Patients will receive 0.5mg/kg Racemic ketamine IV over 40 min three times a week (M, W, F) for 2 consecutive weeks.
Treatment Visit 1: Monday Week 5(baseline seizures diary collected) Treatment Visit 2: Wednesday Week 5 Treatment Visit 3: Friday Week 5 Treatment Visit 4: Monday Week 6 Treatment Visit 5: Wednesday Week 6 Treatment Visit 6: Friday Week 6 (Mood assessments performed prior to infusion)
Post- Treatment Phase : This phase will consist of 5 post infusion safety assessments and 3 post-treatment assessments.
Post-Infusion Safety Assessment 1: Saturday Week 6 (Adverse Event Assessment) Post-Infusion Safety Assessment 2: Sunday Week 7 (Adverse Event Assessment) Post-Infusion Safety Assessment 3: Monday Week 7 (Adverse Event Assessment) Post-Infusion Safety Assessment 4: Monday Week 8 (Adverse Event Assessment) Post-Infusion Safety Assessment 5: Monday Week 9 (Adverse Event Assessment)
Post-Treatment Assessment 1: phone call week 10 (Seizure diary collection, mood assessments performed) Post-Treatment Assessment 2: phone call week 14 (Seizure diary) Post-Treatment Assessment 3: phone call week 18 (Seizure diary collection, mood assessments performed)
Screening : Seizure diary will be prospectively filled for 4 weeks and subjects must have at least 4 seizures in 28 days to proceed to the treatment phase. Baseline mood assessment will be performed (NDDI-E, QOLIE-10, GAD 7 )
Treatment Phase: This phase will consist of 6 study visits (3 visits/ week for 2 weeks). Patients will receive 0.5mg/kg Racemic ketamine IV over 40 min three times a week (M, W, F) for 2 consecutive weeks.
Treatment Visit 1: Monday Week 5(baseline seizures diary collected) Treatment Visit 2: Wednesday Week 5 Treatment Visit 3: Friday Week 5 Treatment Visit 4: Monday Week 6 Treatment Visit 5: Wednesday Week 6 Treatment Visit 6: Friday Week 6 (Mood assessments performed prior to infusion)
Post- Treatment Phase : This phase will consist of 5 post infusion safety assessments and 3 post-treatment assessments.
Post-Infusion Safety Assessment 1: Saturday Week 6 (Adverse Event Assessment) Post-Infusion Safety Assessment 2: Sunday Week 7 (Adverse Event Assessment) Post-Infusion Safety Assessment 3: Monday Week 7 (Adverse Event Assessment) Post-Infusion Safety Assessment 4: Monday Week 8 (Adverse Event Assessment) Post-Infusion Safety Assessment 5: Monday Week 9 (Adverse Event Assessment)
Post-Treatment Assessment 1: phone call week 10 (Seizure diary collection, mood assessments performed) Post-Treatment Assessment 2: phone call week 14 (Seizure diary) Post-Treatment Assessment 3: phone call week 18 (Seizure diary collection, mood assessments performed)
Conditions
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Drug Resistant Epilepsy
Medically Refractory Epilepsy
Refractory Epilepsy
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Experimental clinical treatment
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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IV Ketamine Hydrochloride
dose 0.5mg/kg of IV Ketamine Hydrochloride over 40 min
Group Type
EXPERIMENTAL
Ketamine Hydrochloride
Intervention Type
DRUG
Three times a week (M, W, F) for 2 consecutive weeks.
Interventions
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Ketamine Hydrochloride
Three times a week (M, W, F) for 2 consecutive weeks.
Intervention Type
DRUG
Eligibility Criteria
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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.
* 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.)
* 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.)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Madeline Fields
OTHER
Sponsor Role
lead
Responsible Party
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Madeline Fields
Associate Professor of Neurology Co-Director Mount Sinai Epilepsy Center
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Madeline Fields, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine
Lara Marcuse, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine
Locations
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Mount Sinai Hospital
New York, New York, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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aan het Rot M, Collins KA, Murrough JW, Perez AM, Reich DL, Charney DS, Mathew SJ. Safety and efficacy of repeated-dose intravenous ketamine for treatment-resistant depression. Biol Psychiatry. 2010 Jan 15;67(2):139-45. doi: 10.1016/j.biopsych.2009.08.038.
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BACKGROUND
Aram JA, Martin D, Tomczyk M, Zeman S, Millar J, Pohler G, Lodge D. Neocortical epileptogenesis in vitro: studies with N-methyl-D-aspartate, phencyclidine, sigma and dextromethorphan receptor ligands. J Pharmacol Exp Ther. 1989 Jan;248(1):320-8.
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Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9.
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Brodie MJ. Road to refractory epilepsy: the Glasgow story. Epilepsia. 2013 May;54 Suppl 2:5-8. doi: 10.1111/epi.12175.
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Feder A, Parides MK, Murrough JW, Perez AM, Morgan JE, Saxena S, Kirkwood K, Aan Het Rot M, Lapidus KA, Wan LB, Iosifescu D, Charney DS. Efficacy of intravenous ketamine for treatment of chronic posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry. 2014 Jun;71(6):681-8. doi: 10.1001/jamapsychiatry.2014.62.
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Sheth RD, Gidal BE. Refractory status epilepticus: response to ketamine. Neurology. 1998 Dec;51(6):1765-6. doi: 10.1212/wnl.51.6.1765. No abstract available.
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Synowiec AS, Singh DS, Yenugadhati V, Valeriano JP, Schramke CJ, Kelly KM. Ketamine use in the treatment of refractory status epilepticus. Epilepsy Res. 2013 Jul;105(1-2):183-8. doi: 10.1016/j.eplepsyres.2013.01.007. Epub 2013 Jan 29.
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Walker MC, Howard RS, Smith SJ, Miller DH, Shorvon SD, Hirsch NP. Diagnosis and treatment of status epilepticus on a neurological intensive care unit. QJM. 1996 Dec;89(12):913-20. doi: 10.1093/qjmed/89.12.913.
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Yeh PS, Shen HN, Chen TY. Oral ketamine controlled refractory nonconvulsive status epilepticus in an elderly patient. Seizure. 2011 Nov;20(9):723-6. doi: 10.1016/j.seizure.2011.06.001. Epub 2011 Jul 2.
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Zarate CA Jr, Singh JB, Carlson PJ, Brutsche NE, Ameli R, Luckenbaugh DA, Charney DS, Manji HK. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006 Aug;63(8):856-64. doi: 10.1001/archpsyc.63.8.856.
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Zeiler FA, Kaufmann AM, Gillman LM, West M, Silvaggio J. Ketamine for medically refractory status epilepticus after elective aneurysm clipping. Neurocrit Care. 2013 Aug;19(1):119-24. doi: 10.1007/s12028-013-9858-6.
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Zeiler FA, Teitelbaum J, Gillman LM, West M. NMDA antagonists for refractory seizures. Neurocrit Care. 2014 Jun;20(3):502-13. doi: 10.1007/s12028-013-9939-6.
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Other Identifiers
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STUDY-20-01911
Identifier Type: -
Identifier Source: org_study_id
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