Multiple SclerosisMSNACNCT03032601
Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis
A study testing N-acetyl Cysteine in people with Multiple Sclerosis, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- N-acetyl Cysteine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2017to 8 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 18 years old to no upper limit
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis
- Being tested
- N-acetyl Cysteine
- Keywords
- MS (Multiple Sclerosis), Acute Fulminating, Sclerosis, 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose, 18F Fluorodeoxyglucose 2-Fluoro-2-deoxy-D-glucose (18 FDG), Fludeoxyglucose F 18, Fluorine-18-fluorodeoxyglucose, Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI), PET MRI, Acetylcysteine, N-acetyl cysteine (NAC), Oral supplements, functional magnetic resonance imaging (fMRI), FDG positron emission tomography (FDG PET)
- Medical subject headings
- Multiple Sclerosis, Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl CysteineDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| N-acetyl Cysteine Cohort | Active comparator | 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) Receives: Dietary Supplement: N-acetyl Cysteine |
| Control Cohort | No intervention | Standard of Care Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Baseline and 60 ± 30 days
Secondary outcomes (13)
Mini-Mental Status examination (MMSE)
Questionnaire used to determine eligibility and cognitive function. (exclusion from study if score is 20 or lower)
Measured: Determine eligibility
Multiple Sclerosis Quality of Life Inventory (MSQLI)
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.
Measured: Baseline and 60 ± 30 days
Health Status Questionnaire (SF-36) standard form
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.
Measured: Baseline and 60 ± 30 days
Modified Fatigue Impact Scale (MFIS) standard form
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.
Measured: Baseline and 60 ± 30 days
MOS Pain Effects Scale (PES)
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.
Measured: Baseline and 60 ± 30 days
Bladder Control Scale (BLCS)
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.
Measured: Baseline and 60 ± 30 days
Bowel Control Scale (BWCS)
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.
Measured: Baseline and 60 ± 30 days
Impact of Visual Impairment Scale (IVIS)
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.
Measured: Baseline and 60 ± 30 days
Perceived Deficits Questionnaire (PDQ) standard form
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.
Measured: Baseline and 60 ± 30 days
Mental Health Inventory (MHI) standard form
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.
Measured: Baseline and 60 ± 30 days
MOS Modified Social Support Survey (MSSS) standard form
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.
Measured: Baseline and 60 ± 30 days
Sexual Satisfaction Scale (SSS)
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.
Measured: Baseline and 60 ± 30 days
Kurtzke Expanded Disability Status Scale (EDSS)
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.
Measured: Baseline and 60 ± 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start5 Jan 2017
- Primary completion8 Jul 2027 (estimated)
- Study completion8 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Newberg, Thomas Jefferson University
- Investigators
- Daniel A Monti, MD, MBA, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032601
- Sponsor's protocol ID
- 16D.672
- Acronym
- MSNAC
- Status last verified
- Sep 2025
- First submitted
- 19 Jan 2017
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
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.
PubMed 34377857
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03032601
- Acronym / sponsor ID
- MSNAC / 16D.672
- Conditions
- Multiple Sclerosis
- Keywords
- MS (Multiple Sclerosis), Acute Fulminating, Sclerosis, 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose, 18F Fluorodeoxyglucose 2-Fluoro-2-deoxy-D-glucose (18 FDG), Fludeoxyglucose F 18, Fluorine-18-fluorodeoxyglucose, Positron Emission Tomography (PET)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 8 Jul 2027 (estimated)
- Study completion
- 8 Jul 2027 (estimated)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetyl Cysteine Cohort | Active comparator | Dietary Supplement: N-acetyl CysteineIntravenous 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) |
| Control Cohort | No intervention | –Standard of Care Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 18 years old to no upper limit
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetyl CysteineThe 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. | Dietary supplement | N-acetyl Cysteine Cohort |
Primary outcome
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.
13 secondary outcomes
Mini-Mental Status examination (MMSE)
Time frame: Determine eligibility
Multiple Sclerosis Quality of Life Inventory (MSQLI)
Time frame: Baseline and 60 ± 30 days
Health Status Questionnaire (SF-36) standard form
Time frame: Baseline and 60 ± 30 days
Modified Fatigue Impact Scale (MFIS) standard form
Time frame: Baseline and 60 ± 30 days
MOS Pain Effects Scale (PES)
Time frame: Baseline and 60 ± 30 days
Bladder Control Scale (BLCS)
Time frame: Baseline and 60 ± 30 days
Bowel Control Scale (BWCS)
Time frame: Baseline and 60 ± 30 days
Impact of Visual Impairment Scale (IVIS)
Time frame: Baseline and 60 ± 30 days
Perceived Deficits Questionnaire (PDQ) standard form
Time frame: Baseline and 60 ± 30 days
Mental Health Inventory (MHI) standard form
Time frame: Baseline and 60 ± 30 days
MOS Modified Social Support Survey (MSSS) standard form
Time frame: Baseline and 60 ± 30 days
Sexual Satisfaction Scale (SSS)
Time frame: Baseline and 60 ± 30 days
Kurtzke Expanded Disability Status Scale (EDSS)
Time frame: Baseline and 60 ± 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Results publication: PubMed 34377857Shahrampour 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel A Monti, MD, MBA principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-acetyl Cysteine in people with Multiple Sclerosis, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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. (time frame: Baseline and 60 ± 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03032601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.