Bioavailability of Ubiquinol in Huntington Disease

NCT00980694 | Completed Phase 1

• 1 other identifier: UQ01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Huntington Disease

Keywords

ubiquinol; coenzyme Q10; Huntington disease

Outcome Measures

Primary Outcomes (1)

• serum coenzyme Q10 levels

  8 weeks

Study Arms (1)

Ubiquinol

EXPERIMENTAL

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

Dietary Supplement: ubiquinol

Interventions

ubiquinol DIETARY_SUPPLEMENT

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

Ubiquinol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Kaneka Corporation: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14618, United States

Location

MeSH Terms

Conditions

Huntington Disease

Interventions

ubiquinol

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Karl Kieburtz, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 21, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

US (1)