Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04400331 |
Recruitment Status :
Active, not recruiting
First Posted : May 22, 2020
Last Update Posted : November 2, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chorea, Huntington | Drug: Valbenazine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 154 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease |
Actual Study Start Date : | September 18, 2020 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | December 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Valbenazine
Capsule, administered orally once daily.
|
Drug: Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Other Name: NBI-98854 |
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 156 weeks ]
- Change from Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score [ Time Frame: Up to 156 weeks ]The TMC is part of the motor assessment of the UHDRS and measures chorea in 7 different body parts including the face, oral-buccal-lingual region, trunk and each limb independently. The TMC score is the sum of the individual scores and ranges from 0 to 28. A decrease in score indicates improvement in chorea.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Either #1 or #2 must be met for inclusion eligibility.
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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)
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Did not participate in Study NBI-98854-HD3005 and
- Have a clinical and genetic diagnosis of Huntington Disease (HD) with chorea
- Be able to walk, with or without the assistance of a person or device
- 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
- 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:
- 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
- Have a known hypersensitivity to any component of the formulation of valbenazine
- For participants who did not participate in NBI-98854-HD3005: have a history of VMAT2 inhibitor use within 30 days of baseline

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400331
United States, Alabama | |
Neurocrine Clinical Site | |
Birmingham, Alabama, United States, 35294 | |
United States, Arkansas | |
Neurocrine Clinical Site | |
Little Rock, Arkansas, United States, 72205 | |
United States, California | |
Neurocrine Clinical Site | |
La Jolla, California, United States, 92037 | |
United States, Colorado | |
Neurocrine Clinical Site | |
Aurora, Colorado, United States, 80045 | |
United States, District of Columbia | |
Neurocrine Clinical Site | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Neurocrine Clinical Site | |
Boca Raton, Florida, United States, 33431 | |
Neurocrine Clinical Site | |
Gainesville, Florida, United States, 32608 | |
United States, Georgia | |
Neurocrine Clinical Site | |
Atlanta, Georgia, United States, 30329 | |
United States, Illinois | |
Neurocrine Clinical Site | |
Chicago, Illinois, United States, 60611 | |
Neurocrine Clinical Site | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Neurocrine Clinical Site | |
Indianapolis, Indiana, United States, 46202 | |
United States, Iowa | |
Neurocrine Clinical Site | |
Iowa City, Iowa, United States, 52242 | |
United States, Kansas | |
Neurocrine Clinical Site | |
Wichita, Kansas, United States, 67226 | |
United States, Kentucky | |
Neurocrine Clinical Site | |
Louisville, Kentucky, United States, 40202 | |
United States, Louisiana | |
Neurocrine Clinical Site | |
New Orleans, Louisiana, United States, 70121 | |
United States, Massachusetts | |
Neurocrine Clinical Site | |
Boston, Massachusetts, United States, 02215 | |
Neurocrine Clinical Site | |
Charlestown, Massachusetts, United States, 02129 | |
United States, Michigan | |
Neurocrine Clinical Site | |
Ann Arbor, Michigan, United States, 48105 | |
United States, Nebraska | |
Neurocrine Clinical Site | |
Omaha, Nebraska, United States, 68105 | |
United States, New York | |
Neurocrine Clinical Site | |
Rochester, New York, United States, 14618 | |
Neurocrine Clinical Site | |
Williamsville, New York, United States, 14221 | |
United States, North Carolina | |
Neurocrine Clinical Site | |
Durham, North Carolina, United States, 27705 | |
United States, Ohio | |
Neurocrine Clinical Site | |
Columbus, Ohio, United States, 43221 | |
Neurocrine Clinical Site | |
Toledo, Ohio, United States, 43614 | |
United States, Pennsylvania | |
Neurocrine Clinical Site | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, South Carolina | |
Neurocrine Clinical Site | |
Charleston, South Carolina, United States, 29425 | |
Neurocrine Clinical Site | |
Columbia, South Carolina, United States, 29203 | |
Neurocrine Clinical Site | |
Greenville, South Carolina, United States, 29615 | |
United States, Tennessee | |
Neurocrine Clinical Site | |
Nashville, Tennessee, United States, 37212 | |
United States, Texas | |
Neurocrine Clinical Site | |
Houston, Texas, United States, 77054 | |
United States, Vermont | |
Neurocrine Clinical Site | |
Burlington, Vermont, United States, 05401 | |
Canada, British Columbia | |
Neurocrine Clinical Site | |
Vancouver, British Columbia, Canada, V6T 2B5 | |
Canada, Ontario | |
Neurocrine Clinical Site | |
Ottawa, Ontario, Canada, K1Y 4E9 | |
Neurocrine Clinical Site | |
Toronto, Ontario, Canada, MK2 1E1 |
Study Director: | Chief Medical Officer | Chief Medical Officer |
Responsible Party: | Neurocrine Biosciences |
ClinicalTrials.gov Identifier: | NCT04400331 |
Other Study ID Numbers: |
NBI-98854-HD3006 |
First Posted: | May 22, 2020 Key Record Dates |
Last Update Posted: | November 2, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Huntington Disease Chorea 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 Cognition Disorders Neurocognitive Disorders Mental Disorders Neurologic Manifestations |