Sponsored by Neurocrine Biosciences
This is a Phase 3, open-label study to evaluate the long-term safety and tolerability of valbenazine, and to provide subjects continued access to valbenazine for the treatment of chorea associated with Huntington disease.
Status:
Enrolling by invitation only
Formal Name
Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease
Study Type
Interventional (Clinical Trial)
Purpose
Treatment
Canadian Locations:
British Columbia
Location: Neurocrine Clinical Site, Vancouver
British Columbia, Canada V6T 2B5
Status: By Invitation Only
Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria
- Have participated in Study NBI-98854-HD3005 and
- Study drug dosing completion of Study NBI-98854-HD3005, as demonstrated by completed study drug dosing through the follow-up visit
- Early terminated Study NBI-98854-HD3005 for administrative reasons due to COVID-19 (eg, site closure related to COVID-19)
- Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently while participating in the study until 30 days (females) or 90 days (males) after the last dose of the study drug
Exclusion Criteria (eligibility that would exclude you from this study)
- Have difficulty swallowing
- Are currently pregnant or breastfeeding
- Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular (AV) block, uncontrolled bradyarrhythmia, or heart failure
- Have an unstable or serious medical or psychiatric illness
- Have a significant risk of suicidal behavior
- Have a history of substance dependence or substance (drug) or alcohol abuse, within 1 year of screening
- Have received gene therapy at any time
- 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
- Have had a blood loss ≥550 mL or donated blood within 30 days before the baseline visit
- Have a history of severe hepatic impairment or history of protocol specified hematologic abnormalities during the course of the NBI-98854-HD3005 study
- Had a medically significant illness within 30 days before baseline, or any history of neuroleptic malignant syndrome
Source
For more detailed information on this study and others and for the most recent updates, please go to clinicaltrials.gov. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.