Houston, Texas 77030

  • Huntington's Disease

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

Pro00013929


NCT ID:

NCT02509793


Secondary ID:

HSC-MS-13-0878


Study Acronym:


Brief Title:

A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)


Official Title:

A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)


Overall Status:

Recruiting


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Methodist Hospital System


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:William G Ondo, MD
Principal Investigator
The Methodist Hospital System
Primary Contact:William G Ondo, MD
713-363-8390
wondo@houstonmethodist.org

Study Dates

Start Date:August 1, 2018
Completion Date:July 1, 2023
Completion Type:Anticipated
Primary Completion Date:July 1, 2023
Primary Completion Type:Anticipated
Verification Date:September 2019
Last Changed Date:September 18, 2019
First Received Date:July 24, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in Score on the Minnesota Impulsivity Disorders Interview
Time Frame:Baseline and 8 weeks
Safety Issues:False
Description:This is a clinician-administered screening instrument that had shown good reliability and validity in studies of adult and adolescent psychiatric patients.
Outcome Type:Primary Outcome
Measure:Change in Score on the Iowa Gambling Task
Time Frame:Baseline and 8 weeks
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Change in Score on the Montreal Cognitive Impairment Assessment
Time Frame:Baseline and 8 weeks
Safety Issues:False
Description:cognitive screening test designed to assist Health Professionals for detection of mild cognitive impairment, including Alzheimer's disease.
Outcome Type:Secondary Outcome
Measure:Change in Score on the United Huntington's Disease Rating Scale - Motor section
Time Frame:Baseline and 8 weeks
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Change in Score on the Barrat Impulsivity Scale
Time Frame:Baseline and 8 weeks
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Change in Score on the Geriatric Depression Scale
Time Frame:Baseline and 8 weeks
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Change in Score on the Questionnaire for Impulsive Disorders in Parkinson's Disease
Time Frame:Baseline and 8 weeks
Safety Issues:False
Description:A newly developed and tested tool for measuring impulsivity in PD patients.

Study Interventions

Intervention Type:Drug
Name:Tetrabenazine
Description:Xenazine, pill, dose to effect, three times a day, for 12 weeks
Arm Name:Tetrabenazine
Other Name:Xenazine

Study Arms

Study Arm Type:Experimental
Arm Name:Tetrabenazine
Description:Xenazine (tetrabenazine), pill, dosage titrated to effect, three times a day, 12 weeks

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:William Ondo, MD
Agency Class:Industry
Agency Type:Collaborator
Agency Name:H. Lundbeck A/S

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 26, 2020

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