Bioavailability of Ubiquinol in Huntington Disease

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by University of Rochester. Recruitment status was Recruiting

First Received on September 17, 2009. Last Updated on September 18, 2009 History of Changes

Sponsor:	University of Rochester
Collaborator:	Kaneka Corporation
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00980694

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
Huntington Disease	Dietary Supplement: ubiquinol

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:

Genetics Home Reference related topics: chorea-acanthocytosis familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome

MedlinePlus related topics: Huntington's Disease

U.S. FDA Resources

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 ]

Estimated Enrollment:	12
Study Start Date:	September 2009
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years and older
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

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

Contacts

Contact: Lisa Deuel	585-276-3987	lisa.deuel@ctcc.rochester.edu
Contact: Ryan Evans, MD	585-276-4650	ryan.evans@ctcc.rochester.edu

Locations

United States, New York
University of Rochester	Recruiting
Rochester, New York, United States, 14618
Sub-Investigator: Ryan Evans, MD

Sponsors and Collaborators

University of Rochester

Kaneka Corporation

Investigators

Principal Investigator:

Karl Kieburtz, MD

University of Rochester

More Information

No publications provided

Responsible Party:	Karl Kieburtz, University of Rochester
ClinicalTrials.gov Identifier:	NCT00980694 History of Changes
Other Study ID Numbers:	UQ01
Study First Received:	September 17, 2009
Last Updated:	September 18, 2009
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012