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Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Sponsor: Weill Medical College of Cornell University
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.
Official title: Mechanistic Assessment of N-Acetylcysteine as an Antioxidant Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Through Dose Response and Treatment Target Engagement
Key Details
Gender
All
Age Range
21 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
95
Start Date
2020-09-01
Completion Date
2026-04-30
Last Updated
2026-02-25
Healthy Volunteers
No
Interventions
NAC 900mg/day
self administer NAC 900mg/day caplets for a four week period
NAC 3600mg/day
self administer NAC 3600mg/day caplets for a four week period
NAC 0mg/day (Placebo)
self administer NAC 0mg/day (placebo) caplets for a four week period
Locations (1)
Weill Cornell Medicine
New York, New York, United States