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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 : November 9, 2018
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
William Ondo, MD, The Methodist Hospital System

Tracking Information
First Submitted Date  ICMJE July 24, 2015
First Posted Date  ICMJE July 28, 2015
Last Update Posted Date November 9, 2018
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2015)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02509793 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)
Official Title  ICMJE A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)
Brief 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.
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Huntington's Disease
Intervention  ICMJE Drug: Tetrabenazine
Xenazine, pill, dose to effect, three times a day, for 12 weeks
Other Name: Xenazine
Study Arms  ICMJE Experimental: Tetrabenazine
Xenazine (tetrabenazine), pill, dosage titrated to effect, three times a day, 12 weeks
Intervention: Drug: Tetrabenazine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: William G Ondo, MD 713-363-8390 wondo@houstonmethodist.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02509793
Other Study ID Numbers  ICMJE Pro00013929
HSC-MS-13-0878 ( Other Identifier: UTHealth -Houston )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party William Ondo, MD, The Methodist Hospital System
Study Sponsor  ICMJE William Ondo, MD
Collaborators  ICMJE H. Lundbeck A/S
Investigators  ICMJE
Principal Investigator: William G Ondo, MD The Methodist Hospital System
PRS Account The Methodist Hospital System
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP