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CompletedNCT00980694Updated May 27, 2016

Bioavailability of Ubiquinol in Huntington Disease

A Phase 1 interventional study of ubiquinol in Huntington Disease, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-27.

Sponsored by University of Rochester · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

The death of brain cells in Huntington Disease (HD) is thought to be associated with a lack of normal cell energy and harmful brain substances called free radicals. Coenzyme Q10 (CoQ) is a marketed nutritional supplement that may prove useful in HD because it increases cell energy and combats free radicals.

Most studies of CoQ have looked at only one formulation of CoQ ("ubiquinone") in HD. The purpose of the study is to find out if people that switch from the common formulation of CoQ ("ubiquinone") to a different formulation ("ubiquinol") have higher levels of CoQ in their blood after taking the same dose. The investigators also want to find out if this different formulation is tolerable for individuals with HD.

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Conditions studied

  • Huntington Disease

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Keywords

  • ubiquinol
  • coenzyme Q10
  • Huntington disease
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In context

Huntington Disease

285 studies on the registry are indexed under Huntington Disease; 49 are open to participants now.

This study's enrollment of 6 is below the median of 40 across 203 interventional studies indexed under Huntington Disease.

Browse Huntington Disease studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Have manifest Huntington disease
  • Be 18 years of age or older
  • Be taking an oxidized formulation of CoQ for at least 30 days prior to the baseline visit
  • Be on a steady dose of all concomitant medications for at least 30 days prior to the baseline visit

Exclusion criteria

Exclusion Criteria:

  • Have a history of intolerability of sensitivity to CoQ
  • Have an unstable medical or psychiatric illness
  • Be pregnant or breastfeeding; women of childbearing age must use reliable contraception
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Study design

Phase
Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Ubiquinol

    up to 600 mg per day, oral capsules for 8 weeks

    Dietary Supplement: ubiquinol

Interventions

  • Dietary supplementubiquinol

    up to 600 mg per day, oral capsules for 8 weeks

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What researchers measure

Primary outcomes

  1. serum coenzyme Q10 levels

    Time frame: 8 weeks

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Study locations

1 site
  • University of Rochester
    Rochester, New York 14618, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00980694
Lead sponsor
University of Rochester
Collaborators
Kaneka Corporation
Responsible party
Karl Kieburtz (Professor, University of Rochester) — Principal investigator
First posted
Sep 21, 2009
Start date
Sep 2009
Primary completion
Jul 2012
Completion
Jul 2012
Last update
May 27, 2016

Study contacts

Karl Kieburtz, MD
principal investigator · University of Rochester

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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