Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

• Status: Recruiting
• Trial end date: 2025-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)

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.