Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease

NCT ID: NCT01451463

Last Updated: 2017-11-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-04-30

Brief Summary

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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

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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

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Huntington's Disease

Keywords

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Huntington's Disease Chorea Gait Balance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Huntington's Disease
* Able to ambulate independently

Exclusion Criteria

* Other orthopedic or neurological disorder that affects gait or balance
* Pregnancy
* Chorea score \<10 prior to initiation of medication.
* Inability to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lundbeck LLC

INDUSTRY

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Sandra Kostyk

Clinical Assistant Proffessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandra K Kostyk, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2010H0312

Identifier Type: -

Identifier Source: org_study_id