Bioavailability of Ubiquinol in Huntington Disease

This study has been completed.
Sponsor:
Collaborator:
Kaneka Corporation
Information provided by (Responsible Party):
Karl Kieburtz, University of Rochester
ClinicalTrials.gov Identifier:
NCT00980694
First received: September 17, 2009
Last updated: May 25, 2016
Last verified: May 2016

September 17, 2009
May 25, 2016
September 2009
July 2012   (final data collection date for primary outcome measure)
serum coenzyme Q10 levels [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00980694 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioavailability of Ubiquinol in Huntington Disease
Bioavailability of Ubiquinol in Huntington Disease

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Huntington Disease
Dietary Supplement: ubiquinol
up to 600 mg per day, oral capsules for 8 weeks
Experimental: Ubiquinol
up to 600 mg per day, oral capsules for 8 weeks
Intervention: Dietary Supplement: ubiquinol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00980694
UQ01
No
Not Provided
Not Provided
Karl Kieburtz, University of Rochester
University of Rochester
Kaneka Corporation
Principal Investigator: Karl Kieburtz, MD University of Rochester
University of Rochester
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP