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The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy

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ClinicalTrials.gov Identifier: NCT05019885
Recruitment Status : Not yet recruiting
First Posted : August 25, 2021
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Madeline Fields, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE August 18, 2021
First Posted Date  ICMJE August 25, 2021
Last Update Posted Date September 8, 2021
Estimated Study Start Date  ICMJE October 1, 2021
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2021)
  • Number of participants with seizure reduction [ Time Frame: 2 week during active treatment ]
    50% seizure reduction during the 2 week period of active treatment
  • Number of participants with seizure reduction [ Time Frame: 28 days post infusion ]
    50% seizure reduction during the 28 days post-infusion.
  • Seizure frequency [ Time Frame: 3 months post infusion ]
    Return to pre-ketamine infusion seizure frequency in 3 months
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2021)
  • Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score [ Time Frame: Week 6 ]
    The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 - 24, with higher scores indicating more depressive symptoms.
  • Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score [ Time Frame: Week 10 ]
    The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 - 24, with higher scores indicating more depressive symptoms.
  • Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score [ Time Frame: Week 14 ]
    The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 - 24, with higher scores indicating more depressive symptoms.
  • Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score [ Time Frame: Week 18 ]
    The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 - 24, with higher scores indicating more depressive symptoms.
  • Quality of Life in Epilepsy (QOLIE-10) [ Time Frame: Week 6 ]
    Quality of Life in Epilepsy (QOLIE)-10 scale is a validated, reliable instrument measuring quality of life on a scale from 10-51, lower score indicates better health outcome.
  • Quality of Life in Epilepsy (QOLIE-10) [ Time Frame: Week 10 ]
    Quality of Life in Epilepsy (QOLIE)-10 scale is a validated, reliable instrument measuring quality of life on a scale from 10-51, lower score indicates better health outcome.
  • Quality of Life in Epilepsy (QOLIE-10) [ Time Frame: Week 14 ]
    Quality of Life in Epilepsy (QOLIE)-10 scale is a validated, reliable instrument measuring quality of life on a scale from 10-51, lower score indicates better health outcome.
  • Quality of Life in Epilepsy (QOLIE-10) [ Time Frame: Week 18 ]
    Quality of Life in Epilepsy (QOLIE)-10 scale is a validated, reliable instrument measuring quality of life on a scale from 10-51, lower score indicates better health outcome.
  • General Anxiety Disorder 7-item questionnaire (GAD-7) [ Time Frame: week 6 ]
    The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from "0" (not at all) to "3" (nearly every day). The items that users are asked to rank levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more symptoms.
  • General Anxiety Disorder 7-item questionnaire (GAD-7) [ Time Frame: week 10 ]
    The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from "0" (not at all) to "3" (nearly every day). The items that users are asked to rank levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more symptoms.
  • General Anxiety Disorder 7-item questionnaire (GAD-7) [ Time Frame: week 14 ]
    The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from "0" (not at all) to "3" (nearly every day). The items that users are asked to rank levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more symptoms.
  • General Anxiety Disorder 7-item questionnaire (GAD-7) [ Time Frame: week 18 ]
    The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from "0" (not at all) to "3" (nearly every day). The items that users are asked to rank levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more symptoms.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2021)
  • Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score [ Time Frame: Week 6 ]
    The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 - 24, with higher scores indicating more depressive symptoms.
  • Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score [ Time Frame: Week 10 ]
    The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 - 24, with higher scores indicating more depressive symptoms.
  • Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score [ Time Frame: Week 14 ]
    The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 - 24, with higher scores indicating more depressive symptoms.
  • Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score [ Time Frame: Week 18 ]
    The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 - 24, with higher scores indicating more depressive symptoms.
  • Quality of Life in Epilepsy (QOLIE-10) [ Time Frame: Week 6 ]
    Quality of Life in Epilepsy (QOLIE)-10 scale is a validated, reliable instrument measuring quality of life on a scale from 10-51, higher score indicates better health outcome.
  • Quality of Life in Epilepsy (QOLIE-10) [ Time Frame: Week 10 ]
    Quality of Life in Epilepsy (QOLIE)-10 scale is a validated, reliable instrument measuring quality of life on a scale from 10-51, higher score indicates better health outcome.
  • Quality of Life in Epilepsy (QOLIE-10) [ Time Frame: Week 14 ]
    Quality of Life in Epilepsy (QOLIE)-10 scale is a validated, reliable instrument measuring quality of life on a scale from 10-51, higher score indicates better health outcome.
  • Quality of Life in Epilepsy (QOLIE-10) [ Time Frame: Week 18 ]
    Quality of Life in Epilepsy (QOLIE)-10 scale is a validated, reliable instrument measuring quality of life on a scale from 10-51, higher score indicates better health outcome.
  • General Anxiety Disorder 7-item questionnaire (GAD-7) [ Time Frame: week 6 ]
    The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from "0" (not at all) to "3" (nearly every day). The items that users are asked to rank levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more symptoms.
  • General Anxiety Disorder 7-item questionnaire (GAD-7) [ Time Frame: week 10 ]
    The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from "0" (not at all) to "3" (nearly every day). The items that users are asked to rank levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more symptoms.
  • General Anxiety Disorder 7-item questionnaire (GAD-7) [ Time Frame: week 14 ]
    The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from "0" (not at all) to "3" (nearly every day). The items that users are asked to rank levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more symptoms.
  • General Anxiety Disorder 7-item questionnaire (GAD-7) [ Time Frame: week 18 ]
    The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from "0" (not at all) to "3" (nearly every day). The items that users are asked to rank levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more symptoms.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy
Official Title  ICMJE A Pilot Study to Assess the Efficacy of Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy
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.
Detailed Description

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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Experimental clinical treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Drug Resistant Epilepsy
  • Medically Refractory Epilepsy
  • Refractory Epilepsy
Intervention  ICMJE Drug: Ketamine Hydrochloride
Three times a week (M, W, F) for 2 consecutive weeks.
Study Arms  ICMJE Experimental: IV Ketamine Hydrochloride
dose 0.5mg/kg of IV Ketamine Hydrochloride over 40 min
Intervention: Drug: Ketamine Hydrochloride
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 24, 2021)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2024
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Onome Eka, MBBS MPH 212-241-8861 ext 48861 onome.eka@mssm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05019885
Other Study ID Numbers  ICMJE STUDY-20-01911
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Undecided at this time
Responsible Party Madeline Fields, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Madeline Fields
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Madeline Fields, MD Icahn School of Medicine
Principal Investigator: Lara Marcuse, MD Icahn School of Medicine
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date August 4, 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP