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

NCT02509793 | Unknown Phase 4 FDA Drug

• 2 other identifiers: Pro00013929HSC-MS-13-0878
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Huntington's Disease

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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

  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.

  Baseline and 8 weeks

Secondary Outcomes (1)

• Change in Score on the United Huntington's Disease Rating Scale - Motor section

  Baseline and 8 weeks

Study Arms (1)

Tetrabenazine

EXPERIMENTAL

Xenazine (tetrabenazine), pill, dosage titrated to effect, three times a day, 12 weeks

Drug: Tetrabenazine

Interventions

Tetrabenazine DRUG

Xenazine, pill, dose to effect, three times a day, for 12 weeks

Also known as: Xenazine

Tetrabenazine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• William Ondo, MD: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

Methodist Neurological Institute

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Huntington Disease

Interventions

Tetrabenazine

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quinolizines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• William G Ondo, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William G Ondo, MD

CONTACT

713-363-8390; wondo@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: July 28, 2015
• Study Start: August 1, 2018
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: September 2, 2022

Record last verified: 2022-09

Locations

US (1)