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Mucolytic Agent

N-Acetylcysteine for Chronic Fatigue Syndrome (NAC ME/CFS Trial)

Phase 2
Recruiting
Led By Dikoma Shungu, Ph.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females, ages 21 to 60 years (inclusive).
Males or females, ages 21 to 60 years (inclusive)
Must not have
Significant and/or comorbid axis I (especially mood and anxiety) and axis II disorders
Any significant neurological illness or impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre/post 4 weeks of nac supplementation

Summary

This trial is testing whether or not NAC can help with chronic fatigue syndrome/myalgic encephalomyelitis by looking at the response of brain GSH and plasma markers of oxidative stress.

Who is the study for?
This trial is for adults aged 21-60 with a primary diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and low baseline GSH levels. Participants must be able to consent. Excluded are those with significant mental disorders, neurological illnesses, unstable medical conditions, history of alcohol abuse, positive drug or pregnancy tests, or contraindications for MRI.
What is being tested?
The trial is testing the effects of N-Acetylcysteine (NAC) at different doses (900mg/day and 3600mg/day) versus a placebo on brain GSH and plasma markers in ME/CFS patients. The goal is to see if NAC can protect against oxidative stress by restoring cortical GSH reserves.
What are the potential side effects?
Potential side effects from NAC may include gastrointestinal discomfort such as nausea or diarrhea, headaches, rash, or allergic reactions. High doses might increase the risk of these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 60 years old.
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I am between 21 and 60 years old.
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I have been diagnosed with chronic fatigue syndrome.
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I have been diagnosed with chronic fatigue syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have significant mental health issues, including mood or anxiety disorders.
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I have a serious neurological condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre/post 4 weeks of nac supplementation
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre/post 4 weeks of nac supplementation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in GSH levels of treatment response: measure 1
Change in GSH levels of treatment response: measure 2
Secondary study objectives
Therapeutic procedure
Change in Oxidative stress levels of treatment response: measure 2
Change in Oxidative stress levels of treatment response: measure 3
+5 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: NAC 3600mg/dayActive Control1 Intervention
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
Group II: NAC 900mg/dayActive Control1 Intervention
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
Group III: NAC 0mg/day (Placebo)Placebo Group1 Intervention
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

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,087 Previous Clinical Trials
1,148,652 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,378 Previous Clinical Trials
652,097 Total Patients Enrolled
Dikoma Shungu, Ph.D.Principal InvestigatorWeill Medical College of Cornell University

Media Library

N-Acetylcysteine (Mucolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04542161 — Phase 2
Chronic Fatigue Syndrome Research Study Groups: NAC 3600mg/day, NAC 0mg/day (Placebo), NAC 900mg/day
Chronic Fatigue Syndrome Clinical Trial 2023: N-Acetylcysteine Highlights & Side Effects. Trial Name: NCT04542161 — Phase 2
N-Acetylcysteine (Mucolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04542161 — Phase 2
~9 spots leftby Apr 2025
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