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NCT02865460 · ClinicalTrials.gov registry record · Phase 3

Coenzyme Q10 Phase III Trial in Gulf War Illness

A Phase 3 study of Gulf War Illness and Chronic Fatigue, sponsored by VA Office of Research and Development.

Completed
Registry status
Phase 3
Development phase
100
Enrollment target
4
Study locations

NCT02865460 is a Phase 3 study of Gulf War Illness and Chronic Fatigue that has completed, run by VA Office of Research and Development. The registered enrollment target is 100 participants, below the 123-participant average among 14 other Gulf War Illness trials with a reported enrollment target (19% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT02865460, a Phase 3 study of Gulf War Illness and Chronic Fatigue, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
Phase 3
Development phase
100 participants
Enrollment target
4
Study locations

Study Summary

The primary objective of this clinical trial is to determine if treatment with ubiquinol, a form of coenzyme Q10, improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short Form Health Survey 36-item (SF-36), with respect to physical functioning and symptoms. Secondary outcome measures include changes from baseline levels on GWI-associated biomarkers in peripheral blood and GWI-associated symptoms of chronic pain, fatigue, insomnia, activity level, and cognitive and mental functioning.

Interventions

  • DRUG Placebo
  • DRUG Ubiquinol

Study Locations (4)

Florida

  • Miami VA Healthcare System, Miami, FL - Miami

Massachusetts

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA - Boston

Minnesota

  • Minneapolis VA Health Care System, Minneapolis, MN - Minneapolis

New York

  • James J. Peters VA Medical Center, Bronx, NY - The Bronx

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2017-07-24
Est. Completion 2020-12-31
Phase Phase 3

Sponsor

VA Office of Research and Development

1,668 total trials

What the Registry Record Tells You About NCT02865460

The ClinicalTrials.gov registry entry for NCT02865460 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 123-participant average among 14 other Gulf War Illness trials with a reported enrollment target (19% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Gulf War Illness appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02865460 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Florida, Massachusetts, Minnesota.

Frequently Asked Questions

What is clinical trial NCT02865460 about?

NCT02865460 is a clinical study titled "Coenzyme Q10 Phase III Trial in Gulf War Illness". The primary objective of this clinical trial is to determine if treatment with ubiquinol, a form of coenzyme Q10, improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short Form Health Survey 36-i...

What is the current status of trial NCT02865460?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2017-07-24. Estimated completion is 2020-12-31.

What conditions does trial NCT02865460 study?

This clinical trial studies the following conditions: Gulf War Illness, Chronic Fatigue, Ubiquinol, Coenzyme Q10.

What interventions are being tested in trial NCT02865460?

The interventions under investigation include: Placebo (DRUG), Ubiquinol (DRUG).

Who is sponsoring clinical trial NCT02865460?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02865460 being conducted?

This trial has 4 study locations across Florida, Massachusetts, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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