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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 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 15 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG N-acetyl cysteine

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2016-10-01
Est. Completion 2018-06-01
Phase Phase 2

What the Registry Record Tells You About NCT02804594

The ClinicalTrials.gov registry entry for NCT02804594 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02804594 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.