Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Tinetti Mobility Test Score [>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.
Secondary Outcome Measures
- Five Times Sit to Stand Test [>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.
Other Outcome Measures
- Six Condition Romberg Test [>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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2010H0312
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Individuals on Stable Doses of Tetrabenazine |
|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Individuals on Stable Doses of Tetrabenazine |
|---|---|
| Arm/Group Description | 11 Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication. |
| Overall Participants | 11 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
10
90.9%
|
| >=65 years |
1
9.1%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
52.2
(10.0)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
9
81.8%
|
| Male |
2
18.2%
|
| Region of Enrollment (participants) [Number] | |
| United States |
11
100%
|
Outcome Measures
| Title | Tinetti Mobility Test Score |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Individuals 2 Hours After Resuming Tetrabenazine | Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr |
|---|---|---|
| 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 |
| Measure Participants | 11 | 11 |
| Mean (Standard Deviation) [Total Tinetti Mobility Test Score (TMT)] |
19.91
(3.53)
|
17.09
(4.04)
|
| Title | Five Times Sit to Stand Test |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Individuals 2 Hours After Resuming Tetrabenazine | Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr |
|---|---|---|
| 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 |
| Measure Participants | 11 | 11 |
| Mean (Standard Deviation) [seconds to complete 5 sit to stand cycle] |
12.61
(3.00)
|
15.52
(3.81)
|
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 | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .009 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Six Condition Romberg Test |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 11 | 11 |
| Mean (Standard Deviation) [Six Condition Romberg Test score] |
83.08
(27.57)
|
73.26
(16.29)
|
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 | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .114 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Individuals on Stable Doses of Tetrabenazine | |
| 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 (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Individuals on Stable Doses of Tetrabenazine | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Individuals on Stable Doses of Tetrabenazine | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | |
Limitations/Caveats
More Information
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 |
| sandra.kostyk@osumc.edu |
- 2010H0312