Recruiting

Tetrabenazine

Sponsor:

William Ondo, MD

Code:

NCT02509793

Conditions

Huntington's Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tetrabenazine

Study Details

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

Study ID

NCT02509793

Start date

Aug 1, 2018

Status verified date

Sep, 2022

Completion date

Jul 1, 2023

Anticipated

Primary completion date

Jul 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tetrabenazine

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

Interventions

Tetrabenazine

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

Primary outcome measure

  • Change in Score on the Questionnaire for Impulsive Disorders in Parkinson's Disease [ Time Frame: Baseline and 8 weeks ]
  • Change in Score on the Geriatric Depression Scale [ Time Frame: Baseline and 8 weeks ]
  • Change in Score on the Barrat Impulsivity Scale [ Time Frame: Baseline and 8 weeks ]
  • Change in Score on the Minnesota Impulsivity Disorders Interview [ Time Frame: Baseline and 8 weeks ]
  • Change in Score on the Iowa Gambling Task [ Time Frame: Baseline and 8 weeks ]
  • Change in Score on the Montreal Cognitive Impairment Assessment [ Time Frame: Baseline and 8 weeks ]

Central Contacts and Locations

Central contacts

William G Ondo, MD

713-363-8390wondo@houstonmethodist.org

Locations

Methodist Neurological Institute

Recruiting

Houston, Texas, United States, 77030

Contacts

William Ondo, MD

713-363-8390wondo@houstonmethodist.org

More Information

Sponsor

William Ondo, MD

Last update posted

Sep 2, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by William Ondo, MD on 2022-09-02.