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

Primary Purpose

Drug Resistant Epilepsy, Medically Refractory Epilepsy, Refractory Epilepsy

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Sponsored by
Madeline Fields
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Resistant Epilepsy focused on measuring drug resistant epilepsy, subanesthetic Ketamine hydrochloride

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Mount Sinai HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IV Ketamine Hydrochloride

Arm Description

dose 0.5mg/kg of IV Ketamine Hydrochloride over 40 min

Outcomes

Primary Outcome Measures

Number of participants with seizure reduction
50% seizure reduction during the 2 week period of active treatment
Number of participants with seizure reduction
50% seizure reduction during the 28 days post-infusion.
Seizure frequency
Return to pre-ketamine infusion seizure frequency in 3 months

Secondary Outcome Measures

Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score
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
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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.

Full Information

First Posted
August 18, 2021
Last Updated
September 5, 2023
Sponsor
Madeline Fields
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1. Study Identification

Unique Protocol Identification Number
NCT05019885
Brief Title
The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy
Official Title
A Pilot Study to Assess the Efficacy of Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Madeline Fields

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Resistant Epilepsy, Medically Refractory Epilepsy, Refractory Epilepsy
Keywords
drug resistant epilepsy, subanesthetic Ketamine hydrochloride

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Experimental clinical treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IV Ketamine Hydrochloride
Arm Type
Experimental
Arm Description
dose 0.5mg/kg of IV Ketamine Hydrochloride over 40 min
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
Three times a week (M, W, F) for 2 consecutive weeks.
Primary Outcome Measure Information:
Title
Number of participants with seizure reduction
Description
50% seizure reduction during the 2 week period of active treatment
Time Frame
2 week during active treatment
Title
Number of participants with seizure reduction
Description
50% seizure reduction during the 28 days post-infusion.
Time Frame
28 days post infusion
Title
Seizure frequency
Description
Return to pre-ketamine infusion seizure frequency in 3 months
Time Frame
3 months post infusion
Secondary Outcome Measure Information:
Title
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score
Description
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.
Time Frame
Week 6
Title
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score
Description
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.
Time Frame
Week 10
Title
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score
Description
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.
Time Frame
Week 14
Title
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score
Description
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.
Time Frame
Week 18
Title
Quality of Life in Epilepsy (QOLIE-10)
Description
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.
Time Frame
Week 6
Title
Quality of Life in Epilepsy (QOLIE-10)
Description
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.
Time Frame
Week 10
Title
Quality of Life in Epilepsy (QOLIE-10)
Description
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.
Time Frame
Week 14
Title
Quality of Life in Epilepsy (QOLIE-10)
Description
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.
Time Frame
Week 18
Title
General Anxiety Disorder 7-item questionnaire (GAD-7)
Description
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.
Time Frame
week 6
Title
General Anxiety Disorder 7-item questionnaire (GAD-7)
Description
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.
Time Frame
week 10
Title
General Anxiety Disorder 7-item questionnaire (GAD-7)
Description
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.
Time Frame
week 14
Title
General Anxiety Disorder 7-item questionnaire (GAD-7)
Description
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.
Time Frame
week 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Onome Eka, MBBS MPH
Phone
212-241-8861
Ext
48861
Email
onome.eka@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madeline Fields, MD
Organizational Affiliation
Icahn School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lara Marcuse, MD
Organizational Affiliation
Icahn School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Onome Eka, MBBS MPH
Phone
917-982-5055
Ext
48861
Email
onome.eka@mssm.edu
First Name & Middle Initial & Last Name & Degree
Madeline Fields

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Undecided at this time
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The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy

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