Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This is a Phase 3, open-label study to evaluate the long-term safety and tolerability of
valbenazine, and to provide participants continued access to valbenazine for the treatment of
chorea associated with Huntington disease.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Movement Disorders
Enrollment Eligibility
Inclusion Criteria:
Either #1 or #2 must be met for inclusion eligibility.
1. Have participated in Study NBI-98854-HD3005 and
a. Study drug dosing completion of Study NBI-98854-HD3005, as demonstrated by
completed study drug dosing through the follow-up visit or early terminated Study
NBI-98854-HD3005 for administrative reasons due to COVID-19 (for example, site closure
related to COVID-19)
2. Did not participate in Study NBI-98854-HD3005 and
1. Have a clinical and genetic diagnosis of Huntington Disease (HD) with chorea
2. Be able to walk, with or without the assistance of a person or device
3. Be able to read and understand English and capable of providing consent to study
participation or have a legally authorized representative providing consent and the
participant providing assent
4. Participants of childbearing potential must agree to use contraception consistently
while participating in the study until 30 days after last dose of the study treatment
Exclusion Criteria:
1. Have difficulty swallowing
2. Are currently pregnant or breastfeeding
3. Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch
block, atrioventricular (AV) block, uncontrolled bradyarrhythmia, or heart failure
4. Have an unstable or serious medical or psychiatric illness
5. Have a significant risk of suicidal behavior
6. Have a history of substance dependence or substance (drug) or alcohol abuse, within 1
year of screening
7. Have received gene therapy at any time
8. Have received an investigational drug in a clinical study (other than valbenazine)
within 30 days before the baseline visit or plan to use such investigational drug
(other than valbenazine) during the study
9. Have had a blood loss ≥550 mL or donated blood within 30 days before the baseline
visit
10. Have a history of severe hepatic impairment or history of protocol specified
hematologic abnormalities during the course of the NBI-98854-HD3005 study
11. Had a medically significant illness within 30 days before baseline, or any history of
neuroleptic malignant syndrome
12. Have a known hypersensitivity to any component of the formulation of valbenazine
13. For participants who did not participate in NBI-98854-HD3005: have a history of VMAT2
inhibitor use within 30 days of baseline