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

This study has been completed.
Sponsor:
Collaborator:
Lundbeck LLC
Information provided by (Responsible Party):
Sandra Kostyk, Ohio State University
ClinicalTrials.gov Identifier:
NCT01451463
First received: October 10, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451463

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

No publications provided

Responsible Party: Sandra Kostyk, Clinical Assistant Proffessor, Ohio State University
ClinicalTrials.gov 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
Chorea
Gait
Balance

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
 Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Tetrabenazine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013