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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00980694
Other study ID # UQ01
Secondary ID
Status Completed
Phase Phase 1
First received September 17, 2009
Last updated May 25, 2016
Start date September 2009
Est. completion date July 2012

Study information

Verified date May 2016
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

- 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

Study Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
ubiquinol
up to 600 mg per day, oral capsules for 8 weeks

Locations

Country Name City State
United States University of Rochester Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
University of Rochester Kaneka Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum coenzyme Q10 levels 8 weeks Yes
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