- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01834911
Effect of Tetrabenazine on Stroop Interference in HD
March 29, 2018 updated by: Robert Fekete, New York Medical College
Effect of Tetrabenazine on Stroop Interference in Huntington Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10029
- Terence Cardinal Cooke Health Care Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Tetrabenazine withdrawal
Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently taking the medication.
|
Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently on the drug.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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Stroop Interference Score
Time Frame: 6 hours
|
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.
|
6 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2013
Primary Completion (ACTUAL)
January 1, 2018
Study Completion (ACTUAL)
January 1, 2018
Study Registration Dates
First Submitted
April 15, 2013
First Submitted That Met QC Criteria
April 15, 2013
First Posted (ESTIMATE)
April 18, 2013
Study Record Updates
Last Update Posted (ACTUAL)
April 2, 2018
Last Update Submitted That Met QC Criteria
March 29, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Dementia
- Cognition Disorders
- Chorea
- Huntington Disease
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Adrenergic Uptake Inhibitors
- Tetrabenazine
Other Study ID Numbers
- L-10,830
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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