Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (NAC ME/CFS)
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ClinicalTrials.gov Identifier: NCT04542161 |
Recruitment Status :
Recruiting
First Posted : September 9, 2020
Last Update Posted : June 28, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Fatigue Syndrome Myalgic Encephalomyelitis | Drug: NAC 900mg/day Drug: NAC 3600mg/day Drug: NAC 0mg/day (Placebo) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 95 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Other |
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 |
Actual Study Start Date : | September 1, 2020 |
Estimated Primary Completion Date : | April 30, 2025 |
Estimated Study Completion Date : | April 30, 2025 |

Arm | Intervention/treatment |
---|---|
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
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Drug: NAC 900mg/day
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
|
Drug: NAC 3600mg/day
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
|
Drug: NAC 0mg/day (Placebo)
self administer NAC 0mg/day (placebo) caplets for a four week period |
- Change in GSH levels of treatment response [ Time Frame: pre/post 4 weeks of NAC supplementation ]Levels of striatal and occipital cortex GSH, as measured in vivo with 1H MRS,
- Change in Oxidative stress levels of treatment response: measure 1 [ Time Frame: pre/post 4 weeks of NAC supplementation ]Level of F2-isoprostanes, a marker of oxidative stress, in plasma samples obtained
- Change of levels of ventricular CSF lactate of treatment response [ Time Frame: pre/post 4 weeks of NAC supplementation ]Levels of ventricular CSF lactate, as measured in vivo with 1H MRS,
- Change of regional cerebral blood flow (rCBF) of treatment response [ Time Frame: pre/post 4 weeks of NAC supplementation ]Regional cerebral blood flow (rCBF), as measured in vivo with perfusion MRI,
- Change in Oxidative stress levels of treatment response:measure 2 [ Time Frame: pre/post 4 weeks of NAC supplementation ]Level of 8-hydroxy-2-deoxy guanosine (8-OH-2dG), a DNA damage marker, in plasma samples obtained
- Change in Oxidative stress levels of treatment response:measure 3 [ Time Frame: pre/post 4 weeks of NAC supplementation ]Level of reduced (GSH) glutathione, an antioxidant capacity and redox state marker, in plasma obtained
- Change in Oxidative stress levels of treatment response:measure 4 [ Time Frame: pre/post 4 weeks of NAC supplementation ]Level of oxidized (GSSG) glutathione, an antioxidant capacity and redox state marker, in plasma obtained
- Change in Oxidative stress levels of treatment response:measure 5 [ Time Frame: pre/post 4 weeks of NAC supplementation ]Level of GSH peroxidase, an antioxidant enzyme activity marker, in plasma obtained
- Change in Oxidative stress levels of treatment response:measure 6 [ Time Frame: pre/post 4 weeks of NAC supplementation ]Level of protein carbonyls, a protein damage marker, in plasma obtained

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Ages Eligible for Study: | 21 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Significant and/or comorbid axis I (especially mood and anxiety) and axis II disorders.
- Any significant neurological illness or impairment.
- Other unstable medical conditions (asthma, hypertension, endocrine or metabolic disease, etc).
- History alcohol abuse.
- Positive urine toxicology at screening and on days of assessments.
- Positive pregnancy test at screening or on days of assessments.
- Contra-indication for clinical MRI scan (e.g., pacemaker, metallic prosthesis).
- Baseline GSH levels higher than a predefined cutoff value.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04542161
Contact: Xiangling Mao, MS | 2127462632 | xim2004@med.cornell.edu |
United States, New York | |
Weill Cornell Medicine | Recruiting |
New York, New York, United States, 10021 | |
Principal Investigator: Dikoma C. Shungu, Ph.D. | |
Sub-Investigator: Tracy A. Butler, M.D. | |
Sub-Investigator: Xiangling Mao, M.S. |
Principal Investigator: | Dikoma C. Shungu, Ph.D. | Weill Medical College of Cornell University |
Responsible Party: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT04542161 |
Other Study ID Numbers: |
20-01021280 R01NS116887 ( U.S. NIH Grant/Contract ) |
First Posted: | September 9, 2020 Key Record Dates |
Last Update Posted: | June 28, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Fatigue Syndrome, Chronic Syndrome Fatigue Encephalomyelitis Myalgia Disease Pathologic Processes Virus Diseases Infections |
Muscular Diseases Musculoskeletal Diseases Central Nervous System Diseases Nervous System Diseases Neuromuscular Diseases Central Nervous System Infections Musculoskeletal Pain Pain Neurologic Manifestations |