Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lundbeck LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Tinetti Mobility Test Score | 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. | >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine |
| Measure | Description | Time Frame |
|---|---|---|
| Five Times Sit to Stand Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Six Condition Romberg Test | 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Individuals with Huntington's disease who are already on Xenzaine (tetrabenazine) or who have recently been prescribed the medicaion.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sandra K Kostyk, MD,PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Individuals on Stable Doses of Tetrabenazine | Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Individuals on Stable Doses of Tetrabenazine | 11 Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tinetti Mobility Test Score | 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. | Posted | Mean | Standard Deviation | Total Tinetti Mobility Test Score (TMT) | >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Individuals on Stable Doses of Tetrabenazine | Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandra K Kostyk, MD, PhD | The Ohio State University | 6142934969 | sandra.kostyk@osumc.edu |
Not provided
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| D002819 | Chorea |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine |
| >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr | 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 |
|
|
| Secondary | Five Times Sit to Stand Test | 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. | Posted | Mean | Standard Deviation | seconds to complete 5 sit to stand cycle | >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine |
|
|
|
|
| Other Pre-specified | Six Condition Romberg Test | 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. | Posted | Mean | Standard Deviation | Six Condition Romberg Test score | >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine |
|
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
Not provided
Not provided
| D003704 | Dementia |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |