Bioavailability of Ubiquinol in Huntington Disease

May 25, 2016 updated by: Karl Kieburtz, University of Rochester

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14618
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum coenzyme Q10 levels
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Kaneka Corporation

Investigators

  • Principal Investigator: Karl Kieburtz, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

September 17, 2009

First Submitted That Met QC Criteria

September 18, 2009

First Posted (Estimate)

September 21, 2009

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

May 25, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UQ01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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