A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)
Information source: The University of Texas Health Science Center, Houston
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Huntington's Disease
Intervention: Tetrabenazine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: The University of Texas Health Science Center, Houston Overall contact: William G Ondo, MD, Phone: 832-325-7446, Email: william.ondo@uth.tmc.edu
Summary
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.
Clinical Details
Official title: A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in Score on the Questionnaire for Impulsive Disorders in Parkinson's DiseaseChange in Score on the Geriatric Depression Scale Change in Score on the Barrat Impulsivity Scale Change in Score on the Minnesota Impulsivity Disorders Interview Change in Score on the Iowa Gambling Task Change in Score on the Montreal Cognitive Impairment Assessment
Secondary outcome: Change in Score on the United Huntington's Disease Rating Scale - Motor section
Detailed description:
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. Once a subject has provided written informed consent, he/she will be scheduled for a
study visit. All subjects will be evaluated with tests of depression (Geriatric Depression
Scale), impulsivity (Minnesota Impulsivity Scale, QUIP, BIS-11, and computerized impulsivity
scales), and suicidal ideation (Columbia Suicide Scale) as a safety measure before they
actually start taking TBZ. Patients 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 7 ± 1 week after initiating TBZ. Patients will be titrated over 2- 4 weeks to
best dose as determined by the investigator, up to a maximum of 75 mg/day.
In our clinical practice, >90% of HD patients take 75mg or less per day. This also allows
for a more consistent and shorter titration period to improve patient retention. 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. Determination of best
dose will include one scheduled phone call and others as needed. Other medications will
remain stable between visits.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- For HD patients only--Definite HD (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. We will employ the standard
clinical criteria for symptomatic HD, any motor signs c/w HD, usually chorea).
- Patient is cognitively alert and able to answer/understand.
Exclusion Criteria:
- 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
Locations and Contacts
William G Ondo, MD, Phone: 832-325-7446, Email: william.ondo@uth.tmc.edu
University of Texas Health Science Center at Houston, Houston, Texas 77030, United States; Recruiting William Ondo, MD, Phone: 832-325-7446, Email: william.ondo@uth.tmc.edu
Additional Information
Starting date: April 2014
Last updated: July 27, 2015
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