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Coenzyme Q10

Coenzyme Q10 for Gulf War Syndrome

Phase 3
Recruiting
Led By Beatrice A Golomb, MD, PhD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
On Coumadin/warfarin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5-7 months (from primary endpoint phase to the seven month phase, quadruple blinding is retained for the coq10 dose, but all parties are aware that this phase involves only active treatment.)
Awards & highlights
Pivotal Trial

Summary

This trial aims to see if a high-quality form of ubiquinone (coenzyme Q10) can improve symptoms, daily functioning, and overall quality of life in veterans with Gulf War illness.

Who is the study for?
This trial is for veterans who have Gulf War illness, which may include conditions like mitochondrial disease or myopathy. Participants should not have other serious medical issues that could interfere with the study.
What is being tested?
The study is testing if a high-quality ubiquinone (coenzyme Q10) supplement can improve symptoms, daily functioning, and life quality in those affected by Gulf War illness.
What are the potential side effects?
Coenzyme Q10 is generally well-tolerated but can sometimes cause mild side effects such as stomach upset, loss of appetite, nausea, diarrhea, and possible allergic skin rashes.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am taking Coumadin/warfarin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5-7 months (from primary endpoint phase to the seven month phase, quadruple blinding is retained for the coq10 dose, but all parties are aware that this phase involves only active treatment.)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5-7 months (from primary endpoint phase to the seven month phase, quadruple blinding is retained for the coq10 dose, but all parties are aware that this phase involves only active treatment.) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. placebo.
Secondary study objectives
Effect of CoQ10 in the majority male subset on GSRH.
Effect of CoQ10 in the majority male subset on symptoms.
Effect of CoQ10 in the majority male subset on timed chair rises.
+4 more
Other study objectives
Blood Pressure
Dropouts for Cause. The investigator will report participants who drop out for a reason.
Duration Effect on GSRH. Compare effects of 7 months vs 3.5 months of treatment, assessed at the same time point after baseline (7 months) on GSRH.
+7 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: CoQ10 Arm 1Active Control1 Intervention
PharmaNord Ubiquinone 100mg/1x day
Group II: CoQ10 Arm 2Active Control1 Intervention
PharmaNord Ubiquinone 100mg/3x day
Group III: Placebo ArmPlacebo Group1 Intervention
Placebo (made by PharmaNord, matches active treatment)

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,864 Total Patients Enrolled
1 Trials studying Gulf War Syndrome
15 Patients Enrolled for Gulf War Syndrome
United States Department of DefenseFED
908 Previous Clinical Trials
333,488 Total Patients Enrolled
7 Trials studying Gulf War Syndrome
435 Patients Enrolled for Gulf War Syndrome
Beatrice A Golomb, MD, PhDPrincipal InvestigatorUniversity of California, San Diego
~128 spots leftby Dec 2027
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