Actively Recruiting

Phase 2
Age: 21Years - 60Years
All Genders
NCT04542161

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

Led by Weill Medical College of Cornell University · Updated on 2026-02-25

95

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

Sponsors

W

Weill Medical College of Cornell University

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Weill Cornell Medicine

New York, New York, United States, 10021

Actively Recruiting

Loading map...

Research Team

X

Xiangling Mao, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here