Huntington DiseasePhase 1NCT00980694
Bioavailability of Ubiquinol in Huntington Disease
A Phase 1 study testing ubiquinol in people with Huntington Disease, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- ubiquinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- ubiquinol
- Keywords
- ubiquinol, coenzyme Q10, Huntington disease
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ubiquinolDietary supplement
up to 600 mg per day, oral capsules for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ubiquinol | Experimental | up to 600 mg per day, oral capsules for 8 weeks Receives: Dietary Supplement: ubiquinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum coenzyme Q10 levels
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Kaneka Corporation
- Responsible party
- Principal investigator, Karl Kieburtz, University of Rochester
- Investigators
- Karl Kieburtz, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980694
- Sponsor's protocol ID
- UQ01
- Status last verified
- May 2016
- First submitted
- 17 Sep 2009
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Ubiquinol in Huntington Disease
- ClinicalTrials.gov ID
- NCT00980694
- Acronym / sponsor ID
- UQ01
- Conditions
- Huntington Disease
- Keywords
- ubiquinol, coenzyme Q10, Huntington disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Kaneka Corporation
- Study start
- Sep 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ubiquinol | Experimental | Dietary Supplement: ubiquinolup to 600 mg per day, oral capsules for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ubiquinolup to 600 mg per day, oral capsules for 8 weeks | Dietary supplement | Ubiquinol |
Primary outcome
serum coenzyme Q10 levels
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Kieburtz, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ubiquinol in people with Huntington Disease, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum coenzyme Q10 levels (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2016.