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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04542161
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chronic Fatigue Syndrome
  • Myalgic Encephalomyelitis

Eligibility Criteria

Sex
ALL
Age
21 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • NAC 900mg/day — DRUG
    self administer NAC 900mg/day caplets for a four week period
  • NAC 3600mg/day — DRUG
    self administer NAC 3600mg/day caplets for a four week period
  • NAC 0mg/day (Placebo) — DRUG
    self administer NAC 0mg/day (placebo) caplets for a four week period

Study Details

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.

Key Dates

Start date
Sep 1, 2020
Status verified
Feb 2026
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
95 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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
  • 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
  • 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

Primary Outcome Measure

Change in GSH levels of treatment response: measure 1 [ Time Frame: pre/post 4 weeks of NAC supplementation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10021
Dikoma C. Shungu, Ph.D. (PRINCIPAL_INVESTIGATOR)
Tracy A. Butler, M.D. (SUB_INVESTIGATOR)
Xiangling Mao, M.S. (SUB_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Weill Cornell Medicine· New York, NY

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