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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre/post 4 weeks of nac supplementation
Awards & highlights
NAC ME/CFS Trial 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.Check my eligibility
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.See study design
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.
NAC ME/CFS Trial 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.
NAC ME/CFS Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in GSH levels of treatment response: measure 1
Change in GSH levels of treatment response: measure 2
Secondary outcome measures
Therapeutic procedure
Change in Oxidative stress levels of treatment response: measure 2
Change in Oxidative stress levels of treatment response: measure 3
+5 moreNAC ME/CFS 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
1,054 Previous Clinical Trials
1,316,214 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,269 Total Patients Enrolled
Dikoma Shungu, Ph.D.Principal InvestigatorWeill Medical College of Cornell University
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to take part in this investigative protocol?
"Those between the ages of 21 and 60 may qualify for this medical trial if they experience chronic fatigue. Currently, there are 95 spots available in total."
Answered by AI
Have any prior examinations explored the effects of administering NAC 900mg/day?
"Currently, 38 clinical trials are in progress for NAC 900mg/day with 7 at the Phase 3 stage. New york City is one of 44 regions that have initiated investigations into the efficacy and safety of this medication."
Answered by AI
Are there vacancies available in this research protocol?
"This medical trial is seeking participants, as reported on clinicaltrials.gov, with the initial posting made on September 1st 2020 and last updated June 24th 2022."
Answered by AI
How many participants can register for the trial at its peak?
"Absolutely. The clinical trial is still open for applications, which were first made available on September 1st 2020 and updated last June 24th 2022. 95 participants are needed to be recruited from a single site."
Answered by AI
Has the federal agency accepted NAC 900mg/day for public consumption?
"The safety of NAC 900mg/day was assessed as a 2, demonstrating that while there is evidence to support its security profile, the efficacy has yet to be studied."
Answered by AI
What maladies can be treated with a daily dosage of NAC 900mg?
"N-acetylcysteine (NAC) at a daily dose of 900mg can be employed to treat corneal ulceration, acute rhinitis, and acetaminophen."
Answered by AI
Is the age cutoff for this experiment exceeding 40 years?
"This research is recruiting participants between 21 and 60 years of age."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Texas
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
What site did they apply to?
Weill Cornell Medicine
Why did patients apply to this trial?
I’ve been suffering with this for years—like many others, have been to several doctors including the dept at Stanford and Duke. I would have filled out the contact info for my current doc but I couldn’t figure out how to get back to this screen:).
PatientReceived 2+ prior treatments
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