Using N-Acetylcysteine to treat Chronic Fatigue Syndrome
Mechanistic Assessment of N-Acetylcysteine as an Antioxidant Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Through Dose Response and Treatment Target Engagement
This study is testing if a supplement called N-Acetylcysteine can help people with Chronic Fatigue Syndrome by improving brain health and reducing fatigue.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 95 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04542161 on ClinicalTrials.gov |
What this trial studies
This phase two clinical trial investigates the effects of N-Acetylcysteine (NAC) on brain glutathione (GSH) levels and oxidative stress markers in patients with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (ME/CFS). The study employs a double-blind, placebo-controlled design with three groups receiving different doses of NAC over four weeks. Participants will undergo assessments including blood tests, surveys, and MRI imaging to evaluate the treatment's impact. The goal is to explore NAC's potential neuroprotective effects and its role in restoring GSH levels in the brain.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 60 with a primary diagnosis of ME/CFS and low baseline GSH levels.
Not a fit: Patients with significant comorbid psychiatric disorders, neurological illnesses, or other unstable medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from ME/CFS, addressing a significant unmet medical need.
How similar studies have performed: While there is limited research on NAC for ME/CFS, similar studies exploring oxidative stress and neuroprotection have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New York, New York
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Dikoma C. Shungu, Ph.D. — Weill Medical College of Cornell University
- Study coordinator: Xiangling Mao, MS
- Email: xim2004@med.cornell.edu
- Phone: 2127462632
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.