Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease
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| First Received Date ICMJE | October 10, 2011 | ||||
| Last Updated Date | May 7, 2013 | ||||
| Start Date ICMJE | April 2010 | ||||
| Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Tinetti Mobility Test Score [ Time Frame: 0-20 hours ] [ Designated as safety issue: No ] Comparison of scores off regular stable dose of tetrabenazine for 18 hours with performance two hours after resuming tetrabenazine |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01451463 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Timed Sit to Stand Test [ Time Frame: 0-20 hours ] [ Designated as safety issue: No ] Comparison off stable dose of tetrabenazine for 18 hours to performance two hours after resumption of tetrabenazine |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE |
Six component Romberg Test [ Time Frame: 0-20 hours ] [ Designated as safety issue: No ] Comparison of performance when off stable dose of tetrabenazine for 20 hours to performance 2 hours after resumption of tetrabenazine. |
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| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease | ||||
| Official Title ICMJE | Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease | ||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Individuals with Huntington's disease who are already on Xenzaine (tetrabenazine) or who have recently been prescribed the medicaion. |
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| Condition ICMJE | Huntington's Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 15 | ||||
| Completion Date | April 2013 | ||||
| Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01451463 | ||||
| Other Study ID Numbers ICMJE | 2010H0312 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sandra Kostyk, Ohio State University | ||||
| Study Sponsor ICMJE | Ohio State University | ||||
| Collaborators ICMJE | Lundbeck LLC | ||||
| Investigators ICMJE |
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| Information Provided By | Ohio State University | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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