Treatment of Chorea Associated with Huntington Disease
Protocol: STUDY00005677
Full Title
Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated with Huntington Disease
Description
This study is to evaluate the long-term safety and tolerability of daily valbenazine (20, 40, 60, or 80mg) for the treatment of chorea associated with Huntington's Disease (HD) for up to 104 weeks. This study will enroll approximately 120 medically stable male and female subjects with HD who previously completed study drug dosing during the maintenance period as well as the study visit at Week 14 for Study NBI-98854-HD3005.

Technical Description

(CSR 210607258369) To evaluate long-term safety and tolerability of valbenazine, administered once daily (qd) for up to 104 weeks in subjects with Huntington disease (HD)To evaluate long-term maintenance of effect of valbenazine for the treatment of chorea associated with HD in approimately 120 subjects with HD who participated in the Phase 3 Study NI-98854-HD3005
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
To participate in this study, subjects must meet the following criteria:
1. Participated in Study NBI-98854-HD3005 and
a) Study drug dosing completion of Study NBI-98854-HD3005, as demonstrated by completed study drug dosing during the dose maintenance period as well as the study visit at Week 14.
b) Early terminated Study NBI-98854-HD3005 for administrative reasons due to COVID-19 (eg, site closure related to COVID-19).
2. Subject has provided a Research Advance Directive; only applicable for subjects who have the capacity to consent at the time of informed consent signing.
3. Subject, or his/her LAR, has voluntarily provided informed consent and has signed an ICF and is willing and able to adhere to the study regimen and study procedures described in the ICF.
4. Subjects who are consented through a LAR must agree to have a reliable caregiver in attendance at all study visits.
Age Group: Adults
Principal Investigator: Kelly Andrzejewski
Contact(s)
Tia Warrick
tiawarri@buffalo.edu
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.