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

This study has been completed.
Lundbeck LLC
Information provided by (Responsible Party):
Sandra Kostyk, Ohio State University Identifier:
First received: October 10, 2011
Last updated: May 7, 2013
Last verified: May 2013

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.

Condition Phase
Huntington's Disease
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease

Resource links provided by NLM:

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Other Outcome Measures:
  • 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.

Enrollment: 15
Study Start Date: April 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01451463

United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Lundbeck LLC
Principal Investigator: Sandra K Kostyk, MD,PhD Ohio State University
  More Information

Responsible Party: Sandra Kostyk, Clinical Assistant Proffessor, Ohio State University Identifier: NCT01451463     History of Changes
Other Study ID Numbers: 2010H0312 
Study First Received: October 10, 2011
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Huntington's Disease

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Cognition Disorders
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurocognitive Disorders
Neurodegenerative Diseases
Adrenergic Agents
Adrenergic Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs processed this record on May 26, 2016