Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

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Brief Title

Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

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

Brief 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.
    

Detailed Description

      This phase two, single-site study will utilize a double-blind, placebo-controlled,
      randomized, pre-/post-treatment design to investigate the effect of NAC dosing on brain GSH
      levels and measure temporally concordant plasma levels of several established circulating
      markers of oxidative stress. Three study groups, of 20 subjects each (for a total of 60 who
      completed all components of the study), will each be administered a different dose (0 mg/day,
      900mg/day, 3600mg/day) of the study intervention over a four week period; N-acetylcysteine
      (NAC) treatment. Subjects receiving 0 mg/day dose will be administered a placebo. Baseline
      visit assessments will include blood collection, survey questionnaires, MRI and MRS imaging.
      Subjects whose initial screening confirms low GSH level at baseline will be provided with a
      4-week supplement of anonymized NAC or placebo caplets. After 4 weeks, subjects will then
      undergo a follow-up visit to repeat the baseline assessments.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change in GSH levels of treatment response

Secondary Outcome

 Change in Oxidative stress levels of treatment response: measure 1

Condition

Chronic Fatigue Syndrome

Intervention

NAC 900mg/day

Study Arms / Comparison Groups

 NAC 900mg/day
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

95

Start Date

September 1, 2020

Completion Date

April 30, 2025

Primary Completion Date

April 30, 2025

Eligibility Criteria

        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.
      

Gender

All

Ages

21 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Dikoma Shungu, Ph.D., 2127462481, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04542161

Organization ID

20-01021280

Secondary IDs

R01NS116887

Responsible Party

Sponsor

Study Sponsor

Weill Medical College of Cornell University

Collaborators

 National Institute of Neurological Disorders and Stroke (NINDS)

Study Sponsor

Dikoma Shungu, Ph.D., Principal Investigator, Weill Cornell Medicine


Verification Date

September 2020