Huntington's DiseaseNCT01451463
Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease
An observational study of Huntington's Disease, run by Ohio State University at 1 site in United States.
Trial summary
In individuals with Huntington's disease (HD), chorea may contribute to balance problems and difficulties with walking, sit to stand transfers and stair climbing that in turn may contribute to high fall rates. Xenazine (tetrabenazine) is a monoamine-depleting drug that is commonly used to reduce chorea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington's Disease
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Apr 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Individuals with Huntington's disease who are already on Xenzaine (tetrabenazine) or who have recently been prescribed the medicaion.
Who may be able to join
- Huntington's Disease
- Able to ambulate independently
Who cannot join
- Other orthopedic or neurological disorder that affects gait or balance
- Pregnancy
- Chorea score <10 prior to initiation of medication.
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
In individuals with Huntington's disease (HD), chorea may contribute to balance problems and difficulties with walking, sit to stand transfers and stair climbing that in turn may contribute to high fall rates. Xenazine (tetrabenazine) is a monoamine-depleting drug that is commonly used to reduce chorea.
The purpose of this study is to compare: 1) spatial and temporal gait measures, 2) performance on functional mobility measures, and 3) amount of daily walking activity before and after administration of Xenazine in individuals with HD. It is hypothesized that the use of Xenazine to decrease chorea will improve functions of 1) gait, 2) sit-to-stand transfers 3) stair climbing and 4) overall daily physical activity and function.
Read the detailed description
Individuals with HD who are ambulatory and are either already taking Xenazine or have been newly prescribed the medication will be recruited for this prospective open-label study. A variety of motor assessments will be preformed while subject are taking Xenazine or after a period off of the medications. These tests include: Unified Huntington's Disease Rating Scale (UHDRS) motor section, GAITRite forward walking, Tinetti Mobility Test, Timed Sit-to-Stand Test, Timed Stair Climb Test, Rhomberg test. A subset of subjects will wear an activity monitoring device on the wrist of the non-dominant hand for 5 consecutive days and nights.
- Conditions
- Huntington's Disease
- Keywords
- Huntington's Disease, Chorea, Gait, Balance
- Medical subject headings
- Huntington Disease, Chorea
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinetti Mobility Test Score
The Tinetti Mobility Test is a clinical test used to assess balance and gait. The Balance sub-score ranges from 0-16 (with 16 reflecting better balance) while the Gait sub-score ranges from 0-12 (with 12 reflecting better gait parameters). The Total Tinetti Mobility Test Score (TMT) is a sum of the two sub-scores with a maximum score of 28. The higher the score the better the gait and balance performance. A comparison of scores off regular stable dose of tetrabenazine for >18 hours with the performance two hours after resuming tetrabenazine was made.
Measured: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine
Secondary outcomes (1)
Five Times Sit to Stand Test
Subjects are asked to sit in a chair with their arms across their chests and asked to stand and sit five times in a row. The time it takes to complete 5 sit to stand cycles is timed with a stop watch. Comparison is made when off stable dose of tetrabenazine for >18 hours to performance 2 hours after resumption of tetrabenazine. Lower time scores are associated with better balance.
Measured: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startApr 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Huntington's DiseaseStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck LLC
- Responsible party
- Principal investigator, Sandra Kostyk, Ohio State University
- Investigators
- Sandra K Kostyk, MD,PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451463
- Sponsor's protocol ID
- 2010H0312
- Status last verified
- Oct 2017
- First submitted
- 10 Oct 2011
- Last updated
- 24 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease
- ClinicalTrials.gov ID
- NCT01451463
- Acronym / sponsor ID
- 2010H0312
- Conditions
- Huntington's Disease
- Keywords
- Huntington's Disease, Chorea, Gait, Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Lundbeck LLC
- Study start
- Apr 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 13 Oct 2011 (estimated)
- Results
- Posted 19 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In individuals with Huntington's disease (HD), chorea may contribute to balance problems and difficulties with walking, sit to stand transfers and stair climbing that in turn may contribute to high fall rates. Xenazine (tetrabenazine) is a monoamine-depleting drug that is commonly used to reduce chorea.
The purpose of this study is to compare: 1) spatial and temporal gait measures, 2) performance on functional mobility measures, and 3) amount of daily walking activity before and after administration of Xenazine in individuals with HD. It is hypothesized that the use of Xenazine to decrease chorea will improve functions of 1) gait, 2) sit-to-stand transfers 3) stair climbing and 4) overall daily physical activity and function.
Detailed description
Individuals with HD who are ambulatory and are either already taking Xenazine or have been newly prescribed the medication will be recruited for this prospective open-label study. A variety of motor assessments will be preformed while subject are taking Xenazine or after a period off of the medications. These tests include: Unified Huntington's Disease Rating Scale (UHDRS) motor section, GAITRite forward walking, Tinetti Mobility Test, Timed Sit-to-Stand Test, Timed Stair Climb Test, Rhomberg test. A subset of subjects will wear an activity monitoring device on the wrist of the non-dominant hand for 5 consecutive days and nights.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with Huntington's disease who are already on Xenzaine (tetrabenazine) or who have recently been prescribed the medicaion.
Key inclusion criteria (2 listed)
- Huntington's Disease
- Able to ambulate independently
Key exclusion criteria (4 listed)
- Other orthopedic or neurological disorder that affects gait or balance
- Pregnancy
- Chorea score <10 prior to initiation of medication.
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tinetti Mobility Test Score
Time frame: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine
The Tinetti Mobility Test is a clinical test used to assess balance and gait. The Balance sub-score ranges from 0-16 (with 16 reflecting better balance) while the Gait sub-score ranges from 0-12 (with 12 reflecting better gait parameters). The Total Tinetti Mobility Test Score (TMT) is a sum of the two sub-scores with a maximum score of 28. The higher the score the better the gait and balance performance. A comparison of scores off regular stable dose of tetrabenazine for >18 hours with the performance two hours after resuming tetrabenazine was made.
1 secondary outcome
Five Times Sit to Stand Test
Time frame: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sandra K Kostyk, MD,PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington's Disease, run by Ohio State University 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 2 inclusion and 4 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 24 Nov 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tinetti Mobility Test Score (time frame: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine). 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 24 Nov 2017.