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Antioxidant
N-Acetyl Cysteine for Multiple Sclerosis (MSNAC Trial)
N/A
Waitlist Available
Led By Daniel A Monti, MD, MBA
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Physically independent, ambulatory
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 60 ± 30 days
Awards & highlights
MSNAC Trial Summary
This trial will test whether N-acetyl cysteine (NAC) can help support cerebral function in patients with Multiple Sclerosis (MS).
Who is the study for?
This trial is for adults with relapsing remitting or progressive Multiple Sclerosis who can travel to Philadelphia. They should be physically independent and either not on MS medication, planning to start one, or on a stable regimen of certain disease-modifying drugs. Participants must use effective contraception if applicable and cannot have conditions that interfere with the study.Check my eligibility
What is being tested?
The trial tests whether N-acetyl cysteine (NAC) supports brain function in MS patients using advanced imaging techniques like PET-MRI scans. It aims to measure changes in cerebral metabolism and myelin structure after administering NAC.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions related to the MRI contrast agent used during scans, as well as general side effects from NAC such as nausea, vomiting, rash or headache.
MSNAC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk and move around on my own.
MSNAC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 60 ± 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 60 ± 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Secondary outcome measures
Bladder Control Scale (BLCS)
Bowel Control Scale (BWCS)
Health Status Questionnaire (SF-36) standard form
+10 moreMSNAC Trial Design
2Treatment groups
Active Control
Group I: N-acetyl Cysteine CohortActive Control1 Intervention
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)
Group II: Control CohortActive Control1 Intervention
Standard of Care Treatment
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Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
444 Previous Clinical Trials
145,569 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
216 Patients Enrolled for Multiple Sclerosis
Daniel A Monti, MD, MBAPrincipal InvestigatorThomas Jefferson University
2 Previous Clinical Trials
55 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had brain surgery that may affect brain scans.I take daily medication to manage my asthma.You weigh more than the maximum weight allowed on the table.You feel very uncomfortable in small spaces and this would make it hard for you to finish imaging tests.I don't have brain conditions that could affect scan readings.I have had a head injury that made me unconscious for more than 48 hours.I don't have any health issues that could affect MS symptom evaluation or study tests.I am taking medication for high blood pressure, diabetes, or to slow blood clotting, or nitroglycerin.I have not had IV steroids in the last 90 days for conditions other than MS.I am 18 years old or older.I am using or will use effective birth control during the study.I can walk and move around on my own.I am scheduled for surgery during the study period.Your blood sugar is too high, which could affect the PET scan.I am not on medications that affect how imaging drugs work in my body.You scored 20 or lower on a test that checks memory and thinking skills.I cannot walk and use a wheelchair or stay in bed.You currently abuse alcohol or drugs.I have a history of high blood pressure in the lungs.I don't have any brain or mental health conditions that could affect how a special drug spreads in my body.You cannot have an MRI if you have metal objects inside your body, like a pacemaker.I have MS and am not starting new meds or am on stable MS medication.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: N-acetyl Cysteine Cohort
- Group 2: Control Cohort
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research experiment actively looking for participants?
"Per clinicaltrials.gov, the recruitment period for this particular trial has already ended; it was initially published on May 1st 2017 and edited lastly in August 26th 2022. Notwithstanding that fact, 555 other medical trials are currently welcoming eligible patients to their studies."
Answered by AI
Are adults eligible to participate in this test?
"Participants in this clinical trial must be of legal consenting age or older but under the age of 80."
Answered by AI
Am I qualified to join this research program?
"This clinical trial is searching for 55 individuals between 18 and 80 years of age who have been medically diagnosed with multiple sclerosis. These patients must also be able to attend their appointments in the Philadelphia area, physically independent, not planning on starting a new medication during study duration, or currently taking stable disease-modifying drugs (e.g. interferon, glatiramer). Female participants are additionally required to take a pregnancy test and employ effective contraceptive methods throughout the course of this pilot project; males should practice contraception if they have partners of childbearing potential."
Answered by AI
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