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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
  Purpose

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.


Condition Intervention Phase
Huntington Disease
Dietary Supplement: ubiquinol
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Bioavailability of Ubiquinol in Huntington Disease

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • serum coenzyme Q10 levels [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: September 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ubiquinol
up to 600 mg per day, oral capsules for 8 weeks
Dietary Supplement: ubiquinol
up to 600 mg per day, oral capsules for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980694

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14618
Sponsors and Collaborators
University of Rochester
Kaneka Corporation
Investigators
Principal Investigator: Karl Kieburtz, MD University of Rochester
  More Information

Responsible Party: Karl Kieburtz, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00980694     History of Changes
Other Study ID Numbers: UQ01 
Study First Received: September 17, 2009
Last Updated: May 25, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
ubiquinol
coenzyme Q10
Huntington disease

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016