Valbenazine for the Treatment of Unwanted Movements in Huntington Disease
Protocol: SITE00000140
Full Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated with Huntington's Disease
Description
This study enrolls adults aged 18-75 who are diagnosed with unwanted movements (chorea) associated with Huntington Disease (HD). The purpose of this study is to learn how well Valbenazine works in reducing these unwanted movements, and learn more about the safety and side effects of this medication. Valbenazine has already been approved by the FDA since April 2017 for the treatment of side effects related to other medications.

This study will last up to 18 weeks and includes up to 9 visits. The first visit is the screening visit which includes a blood sample, urine sample, physical exam, and other small tests which will help the doctor determine if you are eligible for the study. If you are eligible to join, you will be randomly assigned to join 1 of 2 groups. Group 1 will receive valbenazine and Group 2 will receive a placebo (a pill with no active ingredients). Comparing results from both of these groups will help find out if the medication is effective. The next few visits will include adjusting the dose and follow-up visits. This study will take place at the UBMD Neurology Clinic in Buffalo, NY.

Technical Description

Primary Study Objectives:
Evaluate the efficacy of valbenazine to reduce chorea associated with Huntington's disease (HD) using the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) score.

Secondary Study Objectives:
Evaluate the efficacy of valbenazine to reduce chorea associated with HD using the Clinical Global Impression of Change (CGI-C), the Patient Global Impression of Change (PGI-C), and the Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function Short Form and the Neuro-QoL Lower
Extremity Function Short Form.
Evaluate the safety and tolerability of valbenazine in subjects with HD.

Exploratory Substudy Objective:
Evaluate the ability of wearable movement sensors to detect changes in physical activity.
Compensation: Yes
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Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Eligibility
Male and female adults aged 18-75 years
Diagnosis of Huntington Disease
Able to walk (assist devices such as cane or walker are allowed)
Negative pregnancy test for females (determined by blood work at first visit)
Sexually active adults of childbearing age must agree to consistently use birth control methods
Able to read and understand English
Age Group: Adults
Principal Investigator: Kelly Andrzejewski
Contact(s)
RACHEL SHEPHERD
rlaporta@buffalo.edu
+1 716-932-6080 ext. 135
JENNIFER GAY
jgay@ubns.com
+1 716-888-4811
Want to Learn More?
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.