A Phase 4 interventional study of Tetrabenazine in Huntington's Disease, sponsored by William Ondo, MD. Status unknown at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-02.
Sponsored by William Ondo, MD · Phase 4, Interventional, and Treatment
The purpose of this research study is to see if tetrabenazine, which is commonly used to treat Huntington's Disease (HD), reduces the problems of impulsivity that are common in patients with HD. Investigators will also see how the medicine affects aspects of thinking and mood.
This study is an open-label assessment of behavioral symptoms including depression, impulsivity, and suicidal ideations in patients prior to, and after, taking a stable dose of TBZ for Huntington's disease. All subjects will be evaluated with tests of depression (Beck Depression Scale), impulsivity (QUIP, BIS-11, and computerized impulsivity scales), and suicidal ideation (Columbia Suicide Scale) as a safety measure before they actually start taking TBZ. Since there is a significant lack of awareness of emotional and cognitive symptoms (anosagnosia) in patients with HD, collateral sources will be asked to fill out similar questionnaires based on their knowledge and observation of the patient. Patients and collaterals will be asked to return to the clinic for an identical evaluation plus adverse events, after they have been on a stable dose of TBZ for 4 weeks, which would be 8 ± 1 week after initiating TBZ. Patients will be titrated over 3-5 weeks to best dose as determined by the investigator, up to a maximum of 75 mg/day. As patients are titrating, there will be several telephone contacts conducted. The initial dose will be 12.5 mg BID. Best dose will be largely determined by adverse events and subjective efficacy. Determination of best dose will include two scheduled phone calls and others as needed. Other medications will remain stable between visits.
285 studies on the registry are indexed under Huntington Disease; 49 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 203 interventional studies indexed under Huntington Disease.
Browse Huntington Disease studies →William Ondo, MD is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Xenazine (tetrabenazine), pill, dosage titrated to effect, three times a day, 12 weeks
Drug: Tetrabenazine
Xenazine, pill, dose to effect, three times a day, for 12 weeks
Also known as: Xenazine
Change in Score on the Questionnaire for Impulsive Disorders in Parkinson's Disease
A newly developed and tested tool for measuring impulsivity in PD patients.
Time frame: Baseline and 8 weeks
Change in Score on the Geriatric Depression Scale
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.
Time frame: Baseline and 8 weeks
Change in Score on the Barrat Impulsivity Scale
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.
Time frame: Baseline and 8 weeks
Change in Score on the Minnesota Impulsivity Disorders Interview
This is a clinician-administered screening instrument that had shown good reliability and validity in studies of adult and adolescent psychiatric patients.
Time frame: Baseline and 8 weeks
Change in Score on the Iowa Gambling Task
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
Time frame: Baseline and 8 weeks
Change in Score on the Montreal Cognitive Impairment Assessment
cognitive screening test designed to assist Health Professionals for detection of mild cognitive impairment, including Alzheimer's disease.
Time frame: Baseline and 8 weeks
Change in Score on the United Huntington's Disease Rating Scale - Motor section
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.
Time frame: Baseline and 8 weeks
Plan to share: Undecided
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This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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William Ondo, MD