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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 April 2024
• Main ID: NCT03032601
• Date of registration: 19/01/2017
• Prospective Registration: No
• Primary sponsor: Thomas Jefferson University
• Public title: Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis MSNAC
• Scientific title: Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis
• Date of first enrolment: January 5, 2017
• Target sample size: 55
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/ct2/show/NCT03032601
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Daniel A Monti, MD, MBA
• Affiliation: Thomas Jefferson University

Key inclusion & exclusion 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 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.

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Dietary Supplement: N-acetyl Cysteine

Primary Outcome(s)

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]

Secondary Outcome(s)

Bladder Control Scale (BLCS) [Time Frame: Baseline and 60 ± 30 days]

MOS Modified Social Support Survey (MSSS) standard form [Time Frame: Baseline and 60 ± 30 days]

Perceived Deficits Questionnaire (PDQ) standard form [Time Frame: Baseline and 60 ± 30 days]

Impact of Visual Impairment Scale (IVIS) [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]

Multiple Sclerosis Quality of Life Inventory (MSQLI) [Time Frame: Baseline and 60 ± 30 days]

Mental Health Inventory (MHI) standard form [Time Frame: Baseline and 60 ± 30 days]

Bowel Control Scale (BWCS) [Time Frame: Baseline and 60 ± 30 days]

Kurtzke Expanded Disability Status Scale (EDSS) [Time Frame: Baseline and 60 ± 30 days]

Mini-Mental Status examination (MMSE) [Time Frame: Determine eligibility]

Sexual Satisfaction Scale (SSS) [Time Frame: Baseline and 60 ± 30 days]

Health Status Questionnaire (SF-36) standard form [Time Frame: Baseline and 60 ± 30 days]

Secondary ID(s)

16D.672

Source(s) of Monetary Support

Please refer to primary and secondary sponsors