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

October 10, 2011
May 7, 2013
April 2010
April 2013   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT01451463 on ClinicalTrials.gov Archive Site
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
Not Provided
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.
Not Provided
 
Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease
Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Individuals with Huntington's disease who are already on Xenzaine (tetrabenazine) or who have recently been prescribed the medicaion.

Huntington's Disease
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.
 
Completed
15
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01451463
2010H0312
No
Sandra Kostyk, Ohio State University
Ohio State University
Lundbeck LLC
Principal Investigator: Sandra K Kostyk, MD,PhD Ohio State University
Ohio State University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP