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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 : August 11, 2017
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
William Ondo, MD, The Methodist Hospital System

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.

Condition or disease Intervention/treatment Phase
Huntington's Disease Drug: Tetrabenazine Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)
Study Start Date : April 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tetrabenazine
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
Other Name: Xenazine




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: William G Ondo, MD 713-363-8385 wondo@houstonmethodist.org

Locations
United States, Texas
Methodist Neurological Institute Recruiting
Houston, Texas, United States, 77030
Contact: William Ondo, MD    713-363-8385    wondo@houstonmethodiast.org   
Sponsors and Collaborators
William Ondo, MD
H. Lundbeck A/S
Investigators
Principal Investigator: William G Ondo, MD The Methodist Hospital System

Responsible Party: William Ondo, MD, Professor, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT02509793     History of Changes
Other Study ID Numbers: Pro00013929
HSC-MS-13-0878 ( Other Identifier: UTHealth -Houston )
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
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

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Impulsive Behavior
Dementia
Chorea
Dyskinesias
Tetrabenazine
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs