Your session is about to expire
← Back to Search
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 belowSelect...
I am between 21 and 60 years old.
Select...
I am between 21 and 60 years old.
Select...
I have been diagnosed with chronic fatigue syndrome.
Select...
I have been diagnosed with chronic fatigue syndrome.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have significant mental health issues, including mood or anxiety disorders.
Select...
I have a serious neurological condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre/post 4 weeks of nac supplementation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre/post 4 weeks of nac supplementation
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 moreTrial 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
1,092 Previous Clinical Trials
1,154,691 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,385 Previous Clinical Trials
652,593 Total Patients Enrolled
Dikoma Shungu, Ph.D.Principal InvestigatorWeill Medical College of Cornell University
Dikoma C. Shungu, Ph.D.Principal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
76 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to give my consent for treatment.You have a history of alcohol abuse.I am between 21 and 60 years old.You have drugs or other substances in your urine when you are tested.I am between 21 and 60 years old.I have significant mental health issues, including mood or anxiety disorders.Your levels of a substance called GSH are too low before starting the study.I do not have any uncontrolled health conditions like asthma or high blood pressure.You are pregnant when the study screening or assessments are done.I have been diagnosed with chronic fatigue syndrome.Your initial GSH levels are higher than a certain limit.I have a serious neurological condition.I have been diagnosed with chronic fatigue syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: NAC 3600mg/day
- Group 2: NAC 0mg/day (Placebo)
- Group 3: NAC 900mg/day
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.