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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

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Prospective
Condition Huntington's Disease
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Individuals on Stable Doses of Tetrabenazine
Hide Arm/Group Description Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication.
Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Individuals on Stable Doses of Tetrabenazine
Hide Arm/Group Description 11 Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  90.9%
>=65 years
1
   9.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
52.2  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
9
  81.8%
Male
2
  18.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Tinetti Mobility Test Score
Hide Description 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.
Time Frame >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Individuals 2 Hours After Resuming Tetrabenazine Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr
Hide Arm/Group Description:
11 Individuals on stable doses of tetrabenazine were studied on the Tinetti Mobility Test following resumption of medication > 18 hours after being off their regular stable dose of medication.
11 Individuals on stable doses of tetrabenazine were studied on the Tinetti Mobility Test after being off their stable dose of medication for > 18 hours
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: Total Tinetti Mobility Test Score (TMT)
19.91  (3.53) 17.09  (4.04)
2.Secondary Outcome
Title Five Times Sit to Stand Test
Hide Description 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.
Time Frame >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Individuals 2 Hours After Resuming Tetrabenazine Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr
Hide Arm/Group Description:
11 Individuals on stable doses of tetrabenazine were studied on the 5 times sit to stand test following resumption of medication . > 18 hours after being off their medication.
11 Individuals on stable doses of tetrabenazine were studied on the 5 times sit to stand test while off medication
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: seconds to complete 5 sit to stand cycle
12.61  (3.00) 15.52  (3.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individuals 2 Hours After Resuming Tetrabenazine, Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .009
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Other Pre-specified Outcome
Title Six Condition Romberg Test
Hide Description 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.
Time Frame >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Individuals Resuming Their Stable Doses of Tetrabenazine Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr
Hide Arm/Group Description:
11 Individuals on stable doses of tetrabenazine were studied two hours after resuming their medication after being off medication for > 18 hours.
11 Individuals who have been on stable doses of tetrabenazine were studied after being off medication for > 18 hours.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: Six Condition Romberg Test score
83.08  (27.57) 73.26  (16.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individuals Resuming Their Stable Doses of Tetrabenazine, Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .114
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Individuals on Stable Doses of Tetrabenazine
Hide Arm/Group Description Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication.
All-Cause Mortality
Individuals on Stable Doses of Tetrabenazine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Individuals on Stable Doses of Tetrabenazine
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Individuals on Stable Doses of Tetrabenazine
Affected / at Risk (%)
Total   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Sandra K Kostyk, MD, PhD
Organization: The Ohio State University
Phone: 6142934969
Responsible Party: Sandra Kostyk, Ohio State University
ClinicalTrials.gov Identifier: NCT01451463     History of Changes
Other Study ID Numbers: 2010H0312
First Submitted: October 10, 2011
First Posted: October 13, 2011
Results First Submitted: April 23, 2016
Results First Posted: October 19, 2017
Last Update Posted: November 24, 2017