Bioavailability of Ubiquinol in Huntington Disease

NCT00980694 — Phase 1, Completed, 6 participants, University of Rochester

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RegistryNCT00980694
StatusCompleted
PhasePhase 1
Study typeInterventional; na, single group, masking: none
Enrollment6 (Actual)
SponsorUniversity of Rochester (Other); collaborators: Kaneka Corporation
ConditionsHuntington Disease
Interventionsubiquinol (Dietary supplement)
Datesstart 2009-09-01, primary completion 2012-07-01, completion 2012-07-01, first posted 2009-09-21, last updated 2016-05-27
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Huntington Disease All trials of ubiquinol

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
UbiquinolExperimentalDietary Supplement: ubiquinolup to 600 mg per day, oral capsules for 8 weeks
  • ubiquinol (Dietary supplement): up to 600 mg per day, oral capsules for 8 weeks

+Outcome measures

Primary outcomes

  • serum coenzyme Q10 levels [8 weeks]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
University of RochesterRochester, New YorkUnited States

+Investigators