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

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ClinicalTrials.gov Identifier: NCT01451463
Recruitment Status : Completed
First Posted : October 13, 2011
Results First Posted : October 19, 2017
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
Lundbeck LLC
Information provided by (Responsible Party):
Sandra Kostyk, Ohio State University

October 10, 2011
October 13, 2011
April 23, 2016
October 19, 2017
November 24, 2017
April 2010
April 2013   (Final data collection date for primary outcome measure)
Tinetti Mobility Test Score [ Time Frame: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine ]
The Tinetti Mobility Test is a clinical test used to assess balance and gait. The Balance sub-score ranges from 0-16 (with 16 reflecting better balance) while the Gait sub-score ranges from 0-12 (with 12 reflecting better gait parameters). The Total Tinetti Mobility Test Score (TMT) is a sum of the two sub-scores with a maximum score of 28. The higher the score the better the gait and balance performance. A comparison of scores off regular stable dose of tetrabenazine for >18 hours with the performance two hours after resuming tetrabenazine was made.
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Complete list of historical versions of study NCT01451463 on ClinicalTrials.gov Archive Site
Five Times Sit to Stand Test [ Time Frame: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine ]
Subjects are asked to sit in a chair with their arms across their chests and asked to stand and sit five times in a row. The time it takes to complete 5 sit to stand cycles is timed with a stop watch. Comparison is made when off stable dose of tetrabenazine for >18 hours to performance 2 hours after resumption of tetrabenazine. Lower time scores are associated with better balance.
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Six Condition Romberg Test [ Time Frame: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine ]
The Six Condition Romberg Test is used assess static balance. Subjects are tested standing with their arms crossed over their chests and are assessed for 30 seconds in the following 6 conditions: 1) feet together, 2) feet together eyes closed, 3) feet aligned in tandem heel-to-toe position eyes open, 4) feet aligned in tandem heel-to-toe position eyes closed, 5) standing in tandem position while counting backwards by 3's from 100 with eyes open, 6) standing in tandem position while counting backwards by 3's from 100 with eyes closed. Comparison of performances were made when off stable dose of tetrabenazine for > 18 hours to performance 2 hours after resumption of tetrabenazine. If a participant could not hold a stance for the full 30 seconds, then that component of the Romberg test ended at that point with the time of that component scored in seconds; 30 seconds being the maximum score for each of the 6 tests. The total score was calculated as a sum of all of the 6 subset scores.
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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
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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
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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
11
13
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01451463
2010H0312
No
Not Provided
Plan to Share IPD: No
Sandra Kostyk, Ohio State University
Ohio State University
Lundbeck LLC
Principal Investigator: Sandra K Kostyk, MD,PhD Ohio State University
Ohio State University
October 2017