Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease

NCT01451463 | Completed Results

• 1 other identifier: 2010H0312
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

In individuals with Huntington's disease (HD), chorea may contribute to balance problems and difficulties with walking, sit to stand transfers and stair climbing that in turn may contribute to high fall rates. Xenazine (tetrabenazine) is a monoamine-depleting drug that is commonly used to reduce chorea. The purpose of this study is to compare: 1) spatial and temporal gait measures, 2) performance on functional mobility measures, and 3) amount of daily walking activity before and after administration of Xenazine in individuals with HD. It is hypothesized that the use of Xenazine to decrease chorea will improve functions of 1) gait, 2) sit-to-stand transfers 3) stair climbing and 4) overall daily physical activity and function.

Conditions

Huntington's Disease

Keywords

Huntington's Disease; Chorea; Gait; Balance

Outcome Measures

Primary Outcomes (1)

• Tinetti Mobility Test Score

  The Tinetti Mobility Test is a clinical test used to assess balance and gait. The Balance sub-score ranges from 0-16 (with 16 reflecting better balance) while the Gait sub-score ranges from 0-12 (with 12 reflecting better gait parameters). The Total Tinetti Mobility Test Score (TMT) is a sum of the two sub-scores with a maximum score of 28. The higher the score the better the gait and balance performance. A comparison of scores off regular stable dose of tetrabenazine for \>18 hours with the performance two hours after resuming tetrabenazine was made.

  >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine

Secondary Outcomes (1)

• Five Times Sit to Stand Test

  >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine

Other Outcomes (1)

• Six Condition Romberg Test

  >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with Huntington's disease who are already on Xenzaine (tetrabenazine) or who have recently been prescribed the medicaion.

You may qualify if:

• Huntington's Disease
• Able to ambulate independently

You may not qualify if:

• Other orthopedic or neurological disorder that affects gait or balance
• Pregnancy
• Chorea score \<10 prior to initiation of medication.
• Inability to provide informed consent

Sponsors & Collaborators

• Ohio State University: lead
• Lundbeck LLC: collaborator

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Huntington Disease; Chorea

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; 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; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sandra K Kostyk, MD, PhD
• Organization: The Ohio State University

sandra.kostyk@osumc.edu

6142934969

Study Officials

• Sandra K Kostyk, MD,PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Proffessor

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 13, 2011
• Study Start: April 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 24, 2017
• Results First Posted: October 19, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)