Bioavailability of Ubiquinol in Huntington Disease

Huntington Disease Clinical Trial

Official title:

Bioavailability of Ubiquinol in Huntington Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980694
• Other study ID #: UQ01
• 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

• Huntington Disease

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