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 range21 Years – 60 Years

SexALL

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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.

What they're measuring

Change in GSH levels of treatment response: measure 1

Timeframe: pre/post 4 weeks of NAC supplementation

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

Contact for this trial

Xiangling Mao, MS

2127462632 xim2004@med.cornell.edu