Bioavailability of Ubiquinol in Huntington Disease

NCT ID: NCT00980694

Last Updated: 2016-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Huntington Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Ubiquinol

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

Group Type EXPERIMENTAL

ubiquinol

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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ubiquinol

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaneka Corporation

INDUSTRY

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Karl Kieburtz

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karl Kieburtz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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UQ01

Identifier Type: -

Identifier Source: org_study_id

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