Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (NCT04542161) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
United States95 participantsStarted 2020-09-01
Plain-language summary
Chronic fatigue syndrome/myalgic encephalomyelitis (ME/CFS) is an unexplained multisymptom/multisystem disorder for which there are currently no validated treatments. The present exploratory clinical trial aims to advance our understand of the mechanisms of in situ GSH synthesis control through assessment of the response of brain GSH and plasma markers of oxidative stress to different doses of NAC in comparison to placebo, as a potential treatment for ME/CFS that would provide neuroprotection against oxidative stress by restoring cortical GSH reserves. If successful, this exploratory clinical trial would address a significant public health concern by shedding new light onto the mechanisms of action of NAC in brain GSH restoration, which could open a new avenue for the development of potentially effective treatments for a disorder, ME/CFS, that currently has none.
Who can participate
Age range
21 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males or females, ages 21 to 60 years (inclusive).
* Baseline GSH levels at or less than a predefined cutoff value.
* Primary diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
* Willing and capable of providing informed consent.
Exclusion Criteria:
* Significant and/or comorbid axis I (especially mood and anxiety) and axis II disorders.
* Any significant neurological illness or impairment.
* Other unstable medical conditions (asthma, hypertension, endocrine or metabolic disease, etc).
* History alcohol abuse.
* Positive urine toxicology at screening and on days of assessments.
* Positive pregnancy test at screening or on days of assessments.
* Contra-indication for clinical MRI scan (e.g., pacemaker, metallic prosthesis).
* Baseline GSH levels higher than a predefined cutoff value.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in GSH levels of treatment response: measure 1
Timeframe: pre/post 4 weeks of NAC supplementation
2
Change in GSH levels of treatment response: measure 2
Timeframe: pre/post 4 weeks of NAC supplementation
Trial details
NCT IDNCT04542161
SponsorWeill Medical College of Cornell University