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NCT04542161 · ClinicalTrials.gov registry record · Phase 2
Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
A Phase 2 study of Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
- 1
- Study location
NCT04542161 is a Phase 2 study of Chronic Fatigue Syndrome and Myalgic Encephalomyelitis that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 95 participants, below the 7,241-participant average among 14 other Chronic Fatigue Syndrome trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04542161, a Phase 2 study of Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG NAC 900mg/day
- DRUG NAC 3600mg/day
- DRUG NAC 0mg/day (Placebo)
Study Locations (1)
New York
- Weill Cornell Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04542161
The ClinicalTrials.gov registry entry for NCT04542161 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,241-participant average among 14 other Chronic Fatigue Syndrome trials with a reported enrollment target (99% lower). The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Fatigue Syndrome appearing as the primary indexed condition, and to 3 interventions - of which NAC 900mg/day is the first listed.
NCT04542161 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT04542161 about?
NCT04542161 is a clinical study titled "Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome". 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 asse...
What is the current status of trial NCT04542161?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2020-09-01. Estimated completion is 2026-04-30.
What conditions does trial NCT04542161 study?
This clinical trial studies the following conditions: Chronic Fatigue Syndrome, Myalgic Encephalomyelitis.
What interventions are being tested in trial NCT04542161?
The interventions under investigation include: NAC 900mg/day (DRUG), NAC 3600mg/day (DRUG), NAC 0mg/day (Placebo) (DRUG).
Who is sponsoring clinical trial NCT04542161?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04542161 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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