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Tetrabenazine has been shown to improve gating of abnormal visual stimuli and improve postural stability in Huntington disease (HD) patients as measured by computerized dynamic posturography testing. This study aims to elucidate whether partial dopaminergic depletion via low dose tetrabenazine has a similar effect on masking out of abnormal visual stimuli on the Stroop interference test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tetrabenazine withdrawal | Experimental | Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently taking the medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetrabenazine withdrawal | Drug | Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently on the drug. Patients will be examined via Stroop test in the OFF state. Two doses of 12.5 mg tetrabenazine will be introduced, spaced 3 hours apart. Stroop test will be performed 6 hours after initial OFF Stroop test. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stroop Interference Score | Participants will have Stroop Visual Interference Scores measured while OFF tetrabenazine for at least 3 days. Two doses of 12.5 mg tetrabenazine will be subsequently administered: first dose just after the Stroop test and second dose 3 hours later. Stroop Visual Interference Scores will be measured again in the ON state, 6 hours after the initial OFF measurement. Patients are analyzed according to Stroop test using Golden's Interference score (theoretical min -50, theoretical max about 98) calculated from [(W × C)/(W + C)] - CW, where C=color score (0-100), W=word score (0-100), CW=color word score (0-100). The Interference score analyzes cognitive interference during trials of reading of a list of color words which are printed in a different color. Lower or more negative scores are clinically better as they indicate less interference. | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Terence Cardinal Cooke Health Care Center | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22621818 | Background | Fekete R, Davidson A, Ondo WG, Cohen HS. Effect of tetrabenazine on computerized dynamic posturography in Huntington disease patients. Parkinsonism Relat Disord. 2012 Aug;18(7):896-8. doi: 10.1016/j.parkreldis.2012.04.029. Epub 2012 May 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tetrabenazine Withdrawal | Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently taking the medication. Tetrabenazine withdrawal: Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently on the drug. Patients will be examined via Stroop test in the OFF state. Two doses of 12.5 mg tetrabenazine will be introduced, spaced 3 hours apart. Stroop test will be performed 6 hours after initial OFF Stroop test. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tetrabenazine Withdrawal | Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently taking the medication. Tetrabenazine withdrawal: Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently on the drug. Patients will be examined via Stroop test in the OFF state. Two doses of 12.5 mg tetrabenazine will be introduced, spaced 3 hours apart. Stroop test will be performed 6 hours after initial OFF Stroop test. |
| 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 | Change in Stroop Interference Score | Participants will have Stroop Visual Interference Scores measured while OFF tetrabenazine for at least 3 days. Two doses of 12.5 mg tetrabenazine will be subsequently administered: first dose just after the Stroop test and second dose 3 hours later. Stroop Visual Interference Scores will be measured again in the ON state, 6 hours after the initial OFF measurement. Patients are analyzed according to Stroop test using Golden's Interference score (theoretical min -50, theoretical max about 98) calculated from [(W × C)/(W + C)] - CW, where C=color score (0-100), W=word score (0-100), CW=color word score (0-100). The Interference score analyzes cognitive interference during trials of reading of a list of color words which are printed in a different color. Lower or more negative scores are clinically better as they indicate less interference. | Only 1 patient could complete all conditions of the Stroop test. The delta between on and off Stroop test was 1 using Golden's score [(W × C)/(W + C)] - CW | Posted | Number | score on a scale | 72 hours |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tetrabenazine Withdrawal | Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently taking the medication. Tetrabenazine withdrawal: Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently on the drug. Patients will be examined via Stroop test in the OFF state. Two doses of 12.5 mg tetrabenazine will be introduced, spaced 3 hours apart. Stroop test will be performed 6 hours after initial OFF Stroop test. |
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Statistical analysis could not be performed as only one subject was able to provide complete study data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Fekete | New York Medical College | 9143451313 | robert_fekete@nymc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2016 | Mar 29, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Tetrabenazine Withdrawal | Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently taking the medication. Tetrabenazine withdrawal: Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently on the drug. Patients will be examined via Stroop test in the OFF state. Two doses of 12.5 mg tetrabenazine will be introduced, spaced 3 hours apart. Stroop test will be performed 6 hours after initial OFF Stroop test. |
|
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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| D003704 | Dementia |
| D002819 | Chorea |
| 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 |