Back to resultsEffect of Tetrabenazine on Stroop Interference in HD
Primary Purpose
Huntington Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tetrabenazine withdrawal
Sponsored by
About this trial
This is an interventional treatment trial for Huntington Disease focused on measuring Huntington disease, HD, tetrabenazine, Stroop
Eligibility Criteria
Inclusion Criteria:
- Established diagnosis of Huntington disease by movement disorders expert
- Patients currently taking tetrabenazine.
- Patients should not have taken dopamine receptor blocking medication for at least three days
Exclusion Criteria:
-
Sites / Locations
- Terence Cardinal Cooke Health Care Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tetrabenazine withdrawal
Arm Description
Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently taking the medication.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01834911
First Posted
April 15, 2013
Last Updated
March 29, 2018
Sponsor
New York Medical College
1. Study Identification
Unique Protocol Identification Number
NCT01834911
Brief Title
Effect of Tetrabenazine on Stroop Interference in HD
Official Title
Effect of Tetrabenazine on Stroop Interference in Huntington Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Medical College
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease
Keywords
Huntington disease, HD, tetrabenazine, Stroop
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tetrabenazine withdrawal
Arm Type
Experimental
Arm Description
Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently taking the medication.
Intervention Type
Drug
Intervention Name(s)
Tetrabenazine withdrawal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Stroop Interference Score
Description
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.
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Established diagnosis of Huntington disease by movement disorders expert
Patients currently taking tetrabenazine.
Patients should not have taken dopamine receptor blocking medication for at least three days
Exclusion Criteria:
-
Facility Information:
Facility Name
Terence Cardinal Cooke Health Care Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22621818
Citation
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.
Results Reference
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Effect of Tetrabenazine on Stroop Interference in HD
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