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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 September 2022
• Main ID: NCT02509793
• Date of registration: 24/07/2015
• Prospective Registration: Yes
• Primary sponsor: William Ondo, MD
• Public title: A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)
• Scientific title: A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)
• Date of first enrolment: August 1, 2018
• Target sample size: 20
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02509793
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: William G Ondo, MD

• Name: William Ondo, MD

• Name: William G Ondo, MD
• Affiliation: The Methodist Hospital Research Institute

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Huntington's Disease

Intervention(s)

Drug: Tetrabenazine

Primary Outcome(s)

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]

Change in Score on the Barrat Impulsivity Scale [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 Questionnaire for Impulsive Disorders in Parkinson's Disease [Time Frame: Baseline and 8 weeks]

Secondary Outcome(s)

Change in Score on the United Huntington's Disease Rating Scale - Motor section [Time Frame: Baseline and 8 weeks]

Secondary ID(s)

Pro00013929

HSC-MS-13-0878

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

H. Lundbeck A/S