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NCT02804594 · ClinicalTrials.gov registry record · Phase 2
A Study of Oxidative Pathways in MS Fatigue
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT02804594: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT02804594 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02804594, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a 4-week randomized, placebo-controlled, parallel group, double-blind, single center trial on effect of N-acetyl cysteine versus placebo on fatigue in patients with progressive MS defined by McDonald criteria. Subjects who enter the treatment phase of study, will be randomly assigned to either N-acetyl cysteine (1250 mg three times a day) or placebo (three times a day) for 4 weeks. There will be 3 in-person study visits (screening, baseline, and week 4) and 2 visits over the phone (week 2, and week 6 which is 2 weeks after completing last study drug dose). Visits will all occur in the morning to maximize consistency of assessments and evaluate main outcomes within 2 hours of morning dose of study medication. Fatigue questionnaires, and research samples will be obtained before neurological examination, or magnetic resonance imaging. Research blood draws will be obtained just after fatigue questionnaire completion. Brain spectroscopy will be obtained less than 2 hours after morning dose of study drug to maximize detection of the biological effect of study medication.
Primary Outcome
Number of adverse events reported since baseline visit that are related to N-acetyl cysteine will be compared to the number of adverse events reported by participants in the placebo group.
Interventions
- DRUG Placebo
- DRUG N-acetyl cysteine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2016-10-01 |
| Est. Completion | 2018-06-01 |
| Phase | Phase 2 |
What the finished NCT02804594 record still lists
NCT02804594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02804594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02804594 about?
NCT02804594 is a clinical study titled "A Study of Oxidative Pathways in MS Fatigue". This is a 4-week randomized, placebo-controlled, parallel group, double-blind, single center trial on effect of N-acetyl cysteine versus placebo on fatigue in patients with progressive MS defined by McDonald criteria. Subjects who enter the treatment phase of study, will be randomly assigned to eith...
What is the current status of trial NCT02804594?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2016-10-01. Estimated completion is 2018-06-01.
What interventions are being tested in trial NCT02804594?
The interventions under investigation include: Placebo (DRUG), N-acetyl cysteine (DRUG).
Who is sponsoring clinical trial NCT02804594?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02804594's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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