<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03032601</url>
  </required_header>
  <id_info>
    <org_study_id>16D.672</org_study_id>
    <nct_id>NCT03032601</nct_id>
  </id_info>
  <brief_title>Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis</brief_title>
  <acronym>MSNAC</acronym>
  <official_title>Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multiple Sclerosis (MS) is a disease in which the myelin surrounding the nerve cells is&#xD;
      damaged which affects functioning. MS usually is treated with medications designed to reduce&#xD;
      the occurrence of future MS events. Evidence suggests that an important part of the disease&#xD;
      process is damage to the myelin and brain caused by too much oxygen (sometimes called&#xD;
      oxidative stress) or too much inflammation (or swelling).&#xD;
&#xD;
      The overall goal of this study will be to determine whether N-acetyl cysteine (NAC) will help&#xD;
      to support cerebral function in patients with Multiple Sclerosis (MS). This positron emission&#xD;
      tomography magnetic resonance imaging (PET-MRI) study will utilize&#xD;
      18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography FDG PET to&#xD;
      measure cerebral metabolism, along with MRI analysis, to measure metabolism and structural&#xD;
      effects of NAC in patients with MS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The original protocol consisted of two arms. The first arm of this study will receive&#xD;
      intravenous and oral NAC, a strong antioxidant that increases brain glutathione. NAC, is the&#xD;
      N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a common&#xD;
      over-the-counter supplement that is also available as an injectable pharmaceutical that&#xD;
      protects the liver in cases of acetaminophen overdose. Laboratory studies have displayed some&#xD;
      benefits to use of NAC. It has the potential to reduce markers of oxidative damage, protect&#xD;
      against cell death, and to increase glutathione in blood, which might be useful in preventing&#xD;
      oxidative damage in MS patients. The second arm will be a waitlist control receiving standard&#xD;
      MS care. It should be noted that both arms will receive standard of care treatment for MS&#xD;
      while enrolled in the study.&#xD;
&#xD;
      We amended this protocol to increase the enrollment with an additional 30 participants: 15 in&#xD;
      a waitlist group and 15 will receive NAC. Subjects be randomized to either receive NAC or be&#xD;
      placed in a waitlist control group. Those patients receiving NAC would receive a combination&#xD;
      of IV and oral NAC for 4 months. We may obtain NAC serum measures that require a blood draw&#xD;
      at three time points, one at scanning before receiving any NAC, one after the first infusion&#xD;
      dose of NAC before the second dose, and another one at the last scan and the last dose of&#xD;
      NAC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">January 5, 2017</start_date>
  <completion_date type="Anticipated">January 5, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 5, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>Baseline and 60 ± 30 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mini-Mental Status examination (MMSE)</measure>
    <time_frame>Determine eligibility</time_frame>
    <description>Questionnaire used to determine eligibility and cognitive function. (exclusion from study if score is 20 or lower)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple Sclerosis Quality of Life Inventory (MSQLI)</measure>
    <time_frame>Baseline and 60 ± 30 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Status Questionnaire (SF-36) standard form</measure>
    <time_frame>Baseline and 60 ± 30 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Fatigue Impact Scale (MFIS) standard form</measure>
    <time_frame>Baseline and 60 ± 30 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MOS Pain Effects Scale (PES)</measure>
    <time_frame>Baseline and 60 ± 30 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bladder Control Scale (BLCS)</measure>
    <time_frame>Baseline and 60 ± 30 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel Control Scale (BWCS)</measure>
    <time_frame>Baseline and 60 ± 30 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of Visual Impairment Scale (IVIS)</measure>
    <time_frame>Baseline and 60 ± 30 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Deficits Questionnaire (PDQ) standard form</measure>
    <time_frame>Baseline and 60 ± 30 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental Health Inventory (MHI) standard form</measure>
    <time_frame>Baseline and 60 ± 30 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MOS Modified Social Support Survey (MSSS) standard form</measure>
    <time_frame>Baseline and 60 ± 30 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Satisfaction Scale (SSS)</measure>
    <time_frame>Baseline and 60 ± 30 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kurtzke Expanded Disability Status Scale (EDSS)</measure>
    <time_frame>Baseline and 60 ± 30 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">55</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>N-acetyl Cysteine Cohort</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intravenous N-acetyl Cysteine - 50mg in 200ml of D5W over one hour 1 x per week Oral N-acetyl Cysteine - 1 500mg tablet 2 x per day (on days IV N-acetyl cysteine is not administered)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Cohort</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of Care Treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>N-acetyl Cysteine</intervention_name>
    <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, 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.</description>
    <arm_group_label>N-acetyl Cysteine Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of relapsing remitting MS or progressive MS who do not plan to&#xD;
             start a medication during the study, or on stable disease modifying medication&#xD;
             (interferon, glatiramer, dimethyl fumarate, teriflunomide).&#xD;
&#xD;
          -  Age 18 years old to no upper limit&#xD;
&#xD;
          -  Physically independent, ambulatory&#xD;
&#xD;
          -  Women of childbearing potential will confirm a negative pregnancy test and must&#xD;
             practice effective contraception during the period of pilot study. In addition, male&#xD;
             subjects who have a partner of childbearing age should practice effective&#xD;
             contraception.&#xD;
&#xD;
          -  Participants must be able to complete study procedures in the greater Philadelphia&#xD;
             area.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients are excluded who have received treatment with intravenous steroids within the&#xD;
             past 90 days for reasons other than MS&#xD;
&#xD;
          -  Previous brain surgery that would interfere with determination of cerebral metabolism&#xD;
             or structure on the FDG PET-MRI.&#xD;
&#xD;
          -  Score on Mini-Mental Status examination of 20 or lower.&#xD;
&#xD;
          -  Wheelchair-bound or bed-ridden, non-ambulatory.&#xD;
&#xD;
          -  Intracranial abnormalities that may complicate interpretation of the brain scans&#xD;
             (e.g., stroke, tumor, vascular abnormality affecting the target area).&#xD;
&#xD;
          -  History of head trauma with loss of consciousness &gt; 48 hours.&#xD;
&#xD;
          -  History of asthma requiring daily medications for adequate management.&#xD;
&#xD;
          -  Any medical disorder or physical condition that could reasonably be expected to&#xD;
             interfere with the assessment of MS symptoms, or with any of the study assessments&#xD;
             including the PET-MRI imaging.&#xD;
&#xD;
          -  Patients with evidence of a significant psychiatric disorder by history/examination&#xD;
             that would prevent completion of the study will not be allowed to participate.&#xD;
&#xD;
          -  Patients with current alcohol or drug abuse&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  Enrollment in active clinical trial/ experimental therapy within the prior 30 days.&#xD;
&#xD;
          -  Pending surgery during the course of the study.&#xD;
&#xD;
          -  Patients taking medications that might interact with NAC involved in this study will&#xD;
             be evaluated on a case by case basis by the PI or study physician. These medications&#xD;
             include: Medications for high blood pressure; Medications that slow blood clotting;&#xD;
             Medications for diabetes; Nitroglycerin.&#xD;
&#xD;
          -  Patients with history of pulmonary hypertension.&#xD;
&#xD;
          -  Any neurological, psychiatric, or medical condition that might affect the distribution&#xD;
             of the radiopharmaceutical in the body or brain (as determined by Investigator)&#xD;
&#xD;
          -  Currently using medications that might alter the distribution of radiopharmaceuticals&#xD;
             in - -the body or brain (as determined by Investigator)&#xD;
&#xD;
          -  Patient exceeds the weight limit of the table&#xD;
&#xD;
          -  Claustrophobia that would prevent completion of imaging studies&#xD;
&#xD;
          -  Glucose level that would interfere with the FDG PET scan&#xD;
&#xD;
          -  Any additional contraindications for MRI; Has metallic objects (e.g., pacemakers) in&#xD;
             the body&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel A Monti, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas Jefferson University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Shahrampour S, Heholt J, Wang A, Vedaei F, Mohamed FB, Alizadeh M, Wang Z, Zabrecky G, Wintering N, Bazzan AJ, Leist TP, Monti DA, Newberg AB. N-acetyl cysteine administration affects cerebral blood flow as measured by arterial spin labeling MRI in patients with multiple sclerosis. Heliyon. 2021 Jul 16;7(7):e07615. doi: 10.1016/j.heliyon.2021.e07615. eCollection 2021 Jul.</citation>
    <PMID>34377857</PMID>
  </results_reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>August 26, 2022</last_update_submitted>
  <last_update_submitted_qc>August 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Thomas Jefferson University</investigator_affiliation>
    <investigator_full_name>Andrew Newberg</investigator_full_name>
    <investigator_title>Professor, Department of Integrative Medicine and Nutritional Sciences; Professor, Department of Radiology</investigator_title>
  </responsible_party>
  <keyword>MS (Multiple Sclerosis)</keyword>
  <keyword>Acute Fulminating</keyword>
  <keyword>Sclerosis</keyword>
  <keyword>18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose</keyword>
  <keyword>18F Fluorodeoxyglucose 2-Fluoro-2-deoxy-D-glucose (18 FDG)</keyword>
  <keyword>Fludeoxyglucose F 18</keyword>
  <keyword>Fluorine-18-fluorodeoxyglucose</keyword>
  <keyword>Positron Emission Tomography (PET)</keyword>
  <keyword>Magnetic Resonance Imaging (MRI)</keyword>
  <keyword>PET MRI</keyword>
  <keyword>Acetylcysteine</keyword>
  <keyword>N-acetyl cysteine (NAC)</keyword>
  <keyword>Oral supplements</keyword>
  <keyword>functional magnetic resonance imaging (fMRI)</keyword>
  <keyword>FDG positron emission tomography (FDG PET)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetylcysteine</mesh_term>
    <mesh_term>N-monoacetylcystine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data (IPD) available to other researchers.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 4, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT03032601/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03032601
org study id: 16D.672
nct id: NCT03032601
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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 N-acetyl cysteine (NAC) will help
      to support cerebral function in patients with Multiple Sclerosis (MS). This positron emission
      tomography magnetic resonance imaging (PET-MRI) study will utilize
      18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography FDG PET to
      measure cerebral metabolism, along with MRI analysis, to measure metabolism and structural
      effects of NAC in patients with MS.
The original protocol consisted 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.

      We amended this protocol to increase the enrollment with an additional 30 participants: 15 in
      a waitlist group and 15 will receive NAC. Subjects be randomized to either receive NAC or be
      placed in a waitlist control group. Those patients receiving NAC would receive a combination
      of IV and oral NAC for 4 months. We may obtain NAC serum measures that require a blood draw
      at three time points, one at scanning before receiving any NAC, one after the first infusion
      dose of NAC before the second dose, and another one at the last scan and the last dose of
      NAC.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: 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
description: 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.
measure: Mini-Mental Status examination (MMSE)
time frame: Determine eligibility
description: Questionnaire used to determine eligibility and cognitive function. (exclusion from study if score is 20 or lower)
measure: Multiple Sclerosis Quality of Life Inventory (MSQLI)
time frame: Baseline and 60 ± 30 days
description: 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.
measure: Health Status Questionnaire (SF-36) standard form
time frame: Baseline and 60 ± 30 days
description: 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.
measure: Modified Fatigue Impact Scale (MFIS) standard form
time frame: Baseline and 60 ± 30 days
description: 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.
measure: MOS Pain Effects Scale (PES)
time frame: Baseline and 60 ± 30 days
description: 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.
measure: Bladder Control Scale (BLCS)
time frame: Baseline and 60 ± 30 days
description: 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.
measure: Bowel Control Scale (BWCS)
time frame: Baseline and 60 ± 30 days
description: 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.
measure: Impact of Visual Impairment Scale (IVIS)
time frame: Baseline and 60 ± 30 days
description: 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.
measure: Perceived Deficits Questionnaire (PDQ) standard form
time frame: Baseline and 60 ± 30 days
description: 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.
measure: Mental Health Inventory (MHI) standard form
time frame: Baseline and 60 ± 30 days
description: 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.
measure: MOS Modified Social Support Survey (MSSS) standard form
time frame: Baseline and 60 ± 30 days
description: 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.
measure: Sexual Satisfaction Scale (SSS)
time frame: Baseline and 60 ± 30 days
description: 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.
measure: Kurtzke Expanded Disability Status Scale (EDSS)
time frame: Baseline and 60 ± 30 days
description: 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.
arm group label: N-acetyl Cysteine Cohort
arm group type: Active Comparator
description: Intravenous N-acetyl Cysteine - 50mg in 200ml of D5W over one hour 1 x per week Oral N-acetyl Cysteine - 1 500mg tablet 2 x per day (on days IV N-acetyl cysteine is not administered)
arm group label: Control Cohort
arm group type: No Intervention
description: Standard of Care Treatment
intervention type: Dietary Supplement
intervention name: N-acetyl Cysteine
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, 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.
arm group label: N-acetyl Cysteine Cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel A Monti, MD, MBA
role: Principal Investigator
affiliation: Thomas Jefferson University
facility: 
country: United States
citation: Shahrampour S, Heholt J, Wang A, Vedaei F, Mohamed FB, Alizadeh M, Wang Z, Zabrecky G, Wintering N, Bazzan AJ, Leist TP, Monti DA, Newberg AB. N-acetyl cysteine administration affects cerebral blood flow as measured by arterial spin labeling MRI in patients with multiple sclerosis. Heliyon. 2021 Jul 16;7(7):e07615. doi: 10.1016/j.heliyon.2021.e07615. eCollection 2021 Jul.
PMID: 34377857
responsible party type: Principal Investigator
investigator affiliation: Thomas Jefferson University
investigator full name: Andrew Newberg
investigator title: Professor, Department of Integrative Medicine and Nutritional Sciences; Professor, Department of Radiology
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Acetylcysteine
mesh term: N-monoacetylcystine
sharing ipd: No
ipd description: There is no plan to make individual participant data (IPD) available to other researchers.
provided document: 