A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)
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|ClinicalTrials.gov Identifier: NCT02509793|
Recruitment Status : Recruiting
First Posted : July 28, 2015
Last Update Posted : September 2, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Huntington's Disease||Drug: Tetrabenazine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||July 1, 2023|
Xenazine (tetrabenazine), pill, dosage titrated to effect, three times a day, 12 weeks
Xenazine, pill, dose to effect, three times a day, for 12 weeks
Other Name: Xenazine
- Change in Score on the Questionnaire for Impulsive Disorders in Parkinson's Disease [ Time Frame: Baseline and 8 weeks ]A newly developed and tested tool for measuring impulsivity in PD patients.
- Change in Score on the Geriatric Depression Scale [ Time Frame: Baseline and 8 weeks ]This assessment detects depressive symptoms in subjects and is a commonly used neuropsychological scale. It is less influenced by motor / somatic symptoms compared to other depression scales.
- Change in Score on the Barrat Impulsivity Scale [ Time Frame: Baseline and 8 weeks ]Scale is the most widely used self-report measure of impulsive personality traits. The BIS-11 is a 30-item self-report questionnaire that is scored to yield a total score, three second-order factors, and six first-order factors.
- Change in Score on the Minnesota Impulsivity Disorders Interview [ Time Frame: Baseline and 8 weeks ]This is a clinician-administered screening instrument that had shown good reliability and validity in studies of adult and adolescent psychiatric patients.
- Change in Score on the Iowa Gambling Task [ Time Frame: Baseline and 8 weeks ]a widely used, but complex, neuropsychological task of executive function in which mixed outcomes (gains and losses) are experienced together, to performance on a relatively simpler descriptive task, the Cups task, which isolates adaptive decision making for achieving gains and avoiding losses. It is very predictive of impulsive personality traits
- Change in Score on the Montreal Cognitive Impairment Assessment [ Time Frame: Baseline and 8 weeks ]cognitive screening test designed to assist Health Professionals for detection of mild cognitive impairment, including Alzheimer's disease.
- Change in Score on the United Huntington's Disease Rating Scale - Motor section [ Time Frame: Baseline and 8 weeks ]A clinical examination of various cognitive, behavioral, and motor features commonly seen in patients with HD (Huntington Study Group, 1996). This is a standardized test used in most clinical studies of HD.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- For HUntington's Disease (HD) patients only--Definite HD as indicated by positive gene testing or typical symptoms in the context of family history of HD.
- A moderate degree of impulsivity as measured by the Barrat Impulsivity Scale (BIS). (>65)
- Must be symptomatic in the opinion of the investigator. Standard clinical criteria for symptomatic HD will be employed, any motor signs c/w HD, usually chorea.
- Patient is cognitively alert and able to answer/understand.
- Patient requires the assistance of another person to walk, or is non-ambulatory.
- Patient is severely impaired cognitively.
- Patients taking neuroleptic (dopamine blocking) medications within the past 14 days.
- patient is actively suicidal, has untreated or inadequately treated depression, has impaired hepatic function, is taking MAO inhibitors or is taking reserpine or has been off of reserpine for less than 20 days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509793
|Contact: William G Ondo, MDemail@example.com|
|United States, Texas|
|Methodist Neurological Institute||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: William Ondo, MD 713-363-8390 firstname.lastname@example.org|
|Principal Investigator:||William G Ondo, MD||The Methodist Hospital Research Institute|
|Responsible Party:||William Ondo, MD, Professor, The Methodist Hospital Research Institute|
|Other Study ID Numbers:||
HSC-MS-13-0878 ( Other Identifier: UTHealth -Houston )
|First Posted:||July 28, 2015 Key Record Dates|
|Last Update Posted:||September 2, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
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