Mechanistic Assessment of N-Acetylcysteine as an Antioxidant Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Through Dose Response and Treatment Target Engagement

Who is this study for? Patients with Myalgic Encephalomyelitis, Chronic Fatigue Syndrome
What treatments are being studied? N-acetylcysteine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
Weill Cornell Medicine
RECRUITING
New York
Contact Information
Primary
Xiangling Mao, MS
xim2004@med.cornell.edu
2127462632
Time Frame
Start Date: 2020-09-01
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 95
Treatments
Active_comparator: NAC 900mg/day
Subjects who pass screening may be randomly assigned to this arm where they will self administer NAC 900mg/day caplets for a four week period
Active_comparator: NAC 3600mg/day
Subjects who pass screening may be randomly assigned to this arm where they will self administer NAC 3600mg/day caplets for a four week period
Placebo_comparator: NAC 0mg/day (Placebo)
Subjects who pass screening may be randomly assigned to this arm where they will self administer NAC 0mg/day (placebo) caplets for a four week period
Authors
Xiangling Mao
Sponsors
Leads: Weill Medical College of Cornell University
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov