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Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis (MSNAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03032601
Recruitment Status : Active, not recruiting
First Posted : January 26, 2017
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:

Multiple Sclerosis (MS) is a disease in which the myelin surrounding the nerve cells is damaged which affects functioning. MS usually is treated with medications designed to reduce the occurrence of future MS events. Evidence suggests that an important part of the disease process is damage to the myelin and brain caused by too much oxygen (sometimes called oxidative stress) or too much inflammation (or swelling).

The overall goal of this study will be to determine whether NAC will help to support cerebral function in patients with Multiple Sclerosis (MS). This PET-MRI study will utilize FDG PET to measure cerebral metabolism, along with MRI analysis, to measure metabolism and structural effects of NAC in patients with MS.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Dietary Supplement: N-acetyl Cysteine Not Applicable

Detailed Description:
The study consists of two arms. The first arm of this study will receive intravenous and oral NAC, a strong antioxidant that increases brain glutathione. NAC, is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a common over-the-counter supplement that is also available as an injectable pharmaceutical that protects the liver in cases of acetaminophen overdose. Laboratory studies have displayed some benefits to use of NAC. It has the potential to reduce markers of oxidative damage, protect against cell death, and to increase glutathione in blood, which might be useful in preventing oxidative damage in MS patients. The second arm will be a waitlist control receiving standard MS care. It should be noted that both arms will receive standard of care treatment for MS while enrolled in the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis
Actual Study Start Date : January 5, 2017
Estimated Primary Completion Date : January 5, 2020
Estimated Study Completion Date : January 5, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: N-acetyl Cysteine Cohort
Intravenous N-acetyl Cysteine - 50mg in 200ml of D5W over one hour 1 x per week Oral N-acetyl Cysteine - 1 600mg tablet 2 x per day (on days IV N-acetyl cysteine is not administered)
Dietary Supplement: N-acetyl Cysteine
The study consists of two arms. The first arm of this study will receive intravenous and oral NAC, a strong antioxidant that increases brain glutathione, which may be beneficial in MS. NAC, is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a common over-the-counter supplement that is also available as an injectable pharmaceutical that protects the liver in cases of acetaminophen overdose. It has the potential to reduce markers of oxidative damage, protect against cell death, and to increase glutathione in blood, which might be useful in preventing oxidative damage in MS patients. The second arm will be a waitlist control receiving standard MS care. It should be noted that both arms will receive standard of care while enrolled into the study.

No Intervention: Control Cohort
Standard of Care Treatment



Primary Outcome Measures :
  1. Changes in the metabolic activity in the brain, and improved parameters with regard to the inflammation associated with the active lesions based on both MRI and PET findings. [ Time Frame: Baseline and 60 ± 30 days ]
    The goal would be to find a shorter duration of active lesions, reduced impact of the lesions on metabolic activity in the brain, and improved parameters with regard to the inflammation associated with the active lesions based on both MRI and PET findings. Changes on the PET and MRI scans would be correlated with changes in clinical findings and quality of life measures.


Secondary Outcome Measures :
  1. Mini-Mental Status examination (MMSE) [ Time Frame: Determine eligibility ]
    Questionnaire used to determine eligibility and cognitive function. (exclusion from study if score is 20 or lower)

  2. Multiple Sclerosis Quality of Life Inventory (MSQLI) [ Time Frame: Baseline and 60 ± 30 days ]
    Participants in the intervention and waitlist (standard of care) group will be asked to complete the full MSQLI which includes the following 10 scales - SF-36, MFIS, PES, BLCS, BWCS, IVIS, PDQ, MHI, MSSS, and SSS-W. The scales will be conducted at baseline and 60 ± 30 days concurrent to baseline and post scans.

  3. Health Status Questionnaire (SF-36) standard form [ Time Frame: Baseline and 60 ± 30 days ]
    Questionnaire from Multiple Sclerosis Quality of Life Inventory that evaluates the quality of life for those diagnosed with Multiple Sclerosis (MS). Will be used to determine improvements in MS symptoms.

  4. Modified Fatigue Impact Scale (MFIS) standard form [ Time Frame: Baseline and 60 ± 30 days ]
    Questionnaire from Multiple Sclerosis Quality of Life Inventory that evaluates the quality of life for those diagnosed with Multiple Sclerosis (MS). Will be used to determine improvements in MS symptoms.

  5. MOS Pain Effects Scale (PES) [ Time Frame: Baseline and 60 ± 30 days ]
    Questionnaire from Multiple Sclerosis Quality of Life Inventory that evaluates the quality of life for those diagnosed with Multiple Sclerosis (MS). Will be used to determine improvements in MS symptoms.

  6. Bladder Control Scale (BLCS) [ Time Frame: Baseline and 60 ± 30 days ]
    Questionnaire from Multiple Sclerosis Quality of Life Inventory that evaluates the quality of life for those diagnosed with Multiple Sclerosis (MS). Will be used to determine improvements in MS symptoms.

  7. Bowel Control Scale (BWCS) [ Time Frame: Baseline and 60 ± 30 days ]
    Questionnaire from Multiple Sclerosis Quality of Life Inventory that evaluates the quality of life for those diagnosed with Multiple Sclerosis (MS). Will be used to determine improvements in MS symptoms.

  8. Impact of Visual Impairment Scale (IVIS) [ Time Frame: Baseline and 60 ± 30 days ]
    Questionnaire from Multiple Sclerosis Quality of Life Inventory that evaluates the quality of life for those diagnosed with Multiple Sclerosis (MS). Will be used to determine improvements in MS symptoms.

  9. Perceived Deficits Questionnaire (PDQ) standard form [ Time Frame: Baseline and 60 ± 30 days ]
    Questionnaire from Multiple Sclerosis Quality of Life Inventory that evaluates the quality of life for those diagnosed with Multiple Sclerosis (MS). Will be used to determine improvements in MS symptoms.

  10. Mental Health Inventory (MHI) standard form [ Time Frame: Baseline and 60 ± 30 days ]
    Questionnaire from Multiple Sclerosis Quality of Life Inventory that evaluates the quality of life for those diagnosed with Multiple Sclerosis (MS). Will be used to determine improvements in MS symptoms.

  11. MOS Modified Social Support Survey (MSSS) standard form [ Time Frame: Baseline and 60 ± 30 days ]
    Questionnaire from Multiple Sclerosis Quality of Life Inventory that evaluates the quality of life for those diagnosed with Multiple Sclerosis (MS). Will be used to determine improvements in MS symptoms.

  12. Sexual Satisfaction Scale (SSS) [ Time Frame: Baseline and 60 ± 30 days ]
    Questionnaire from Multiple Sclerosis Quality of Life Inventory that evaluates the quality of life for those diagnosed with Multiple Sclerosis (MS). Will be used to determine improvements in MS symptoms.

  13. Kurtzke Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline and 60 ± 30 days ]
    Used to measure neurological impairment in those diagnosed with Multiple Sclerosis on a scale of 0 to 10. Will be used to determine improvements in MS symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of relapsing remitting MS or progressive MS who do not plan to start a medication during the study, or on stable disease modifying medication (interferon, glatiramer, dimethyl fumarate, teriflunomide).
  • Age 30-80 years old
  • Physically independent, ambulatory
  • Women of childbearing potential will confirm a negative pregnancy test and must practice effective contraception during the period of pilot study. In addition, male subjects who have a partner of childbearing age should practice effective contraception.
  • Participants must be able to complete study procedures in the greater Philadelphia area.

Exclusion Criteria:

  • Patients are excluded who have received treatment with intravenous steroids within the past 90 days for reasons other than MS
  • Previous brain surgery that would interfere with determination of cerebral metabolism or structure on the FDG PET-MRI.
  • Score on Mini-Mental Status examination of 20 or lower.
  • Wheelchair-bound or bed-ridden, non-ambulatory.
  • Intracranial abnormalities that may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality affecting the target area).
  • History of head trauma with loss of consciousness > 48 hours.
  • History of asthma requiring daily medications for adequate management.
  • Any medical disorder or physical condition that could reasonably be expected to interfere with the assessment of MS symptoms, or with any of the study assessments including the PET-MRI imaging.
  • Patients with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate.
  • Patients with current alcohol or drug abuse
  • Pregnant or lactating women.
  • Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
  • Pending surgery during the course of the study.
  • Patients taking medications that might interact with NAC involved in this study will be evaluated on a case by case basis by the PI or study physician. These medications include: Medications for high blood pressure; Medications that slow blood clotting; Medications for diabetes; Nitroglycerin.
  • Patients with history of pulmonary hypertension.
  • Any neurological, psychiatric, or medical condition that might affect the distribution of the radiopharmaceutical in the body or brain (as determined by Investigator)
  • Currently using medications that might alter the distribution of radiopharmaceuticals in - -the body or brain (as determined by Investigator)
  • Patient exceeds the weight limit of the table
  • Claustrophobia that would prevent completion of imaging studies
  • Glucose level that would interfere with the FDG PET scan
  • Any additional contraindications for MRI; Has metallic objects (e.g., pacemakers) in the body

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032601


Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Daniel A Monti, MD, MBA Thomas Jefferson University
  Study Documents (Full-Text)

Documents provided by Thomas Jefferson University:

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03032601     History of Changes
Other Study ID Numbers: 16D.672
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas Jefferson University:
MS (Multiple Sclerosis)
Acute Fulminating
Sclerosis
FDG
18F Fluorodeoxyglucose
18F-FDG
18FDG
2-Fluoro-2-deoxy-D-glucose
2-Fluoro-2-deoxyglucose
Fludeoxyglucose F 18
Fluorine-18-fluorodeoxyglucose
Fluorodeoxyglucose F 18
PET Scan
Tomography, Positron-Emission
Magnetic Resonance Imaging, Functional
fMRI
PET-MRI
Acetylcysteine
N-acetyl cysteine
NAC
Oral supplements

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Acetylcysteine
N-monoacetylcystine
Fluorodeoxyglucose F18
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Radiopharmaceuticals