Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease
NCT ID: NCT04400331
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
154 participants
INTERVENTIONAL
2020-09-18
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Valbenazine
Capsule, administered orally once daily.
Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Interventions
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Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Huntington Study Group
NETWORK
Neurocrine Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Chief Medical Officer
Locations
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Neurocrine Clinical Site
Birmingham, Alabama, United States
Neurocrine Clinical Site
Little Rock, Arkansas, United States
Neurocrine Clinical Site
La Jolla, California, United States
Neurocrine Clinical Site
Aurora, Colorado, United States
Neurocrine Clinical Site
Washington D.C., District of Columbia, United States
Neurocrine Clinical Site
Boca Raton, Florida, United States
Neurocrine Clinical Site
Gainesville, Florida, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Neurocrine Clinical Site
Chicago, Illinois, United States
Neurocrine Clinical Site
Chicago, Illinois, United States
Neurocrine Clinical Site
Indianapolis, Indiana, United States
Neurocrine Clinical Site
Iowa City, Iowa, United States
Neurocrine Clinical Site
Wichita, Kansas, United States
Neurocrine Clinical Site
Louisville, Kentucky, United States
Neurocrine Clinical Site
New Orleans, Louisiana, United States
Neurocrine Clinical Site
Boston, Massachusetts, United States
Neurocrine Clinical Site
Charlestown, Massachusetts, United States
Neurocrine Clinical Site
Ann Arbor, Michigan, United States
Neurocrine Clinical Site
Omaha, Nebraska, United States
Neurocrine Clinical Site
Rochester, New York, United States
Neurocrine Clinical Site
Williamsville, New York, United States
Neurocrine Clinical Site
Durham, North Carolina, United States
Neurocrine Clinical Site
Columbus, Ohio, United States
Neurocrine Clinical Site
Toledo, Ohio, United States
Neurocrine Clinical Site
Pittsburgh, Pennsylvania, United States
Neurocrine Clinical Site
Charleston, South Carolina, United States
Neurocrine Clinical Site
Columbia, South Carolina, United States
Neurocrine Clinical Site
Greenville, South Carolina, United States
Neurocrine Clinical Site
Nashville, Tennessee, United States
Neurocrine Clinical Site
Houston, Texas, United States
Neurocrine Clinical Site
Burlington, Vermont, United States
Neurocrine Clinical Site
Vancouver, British Columbia, Canada
Neurocrine Clinical Site
Ottawa, Ontario, Canada
Neurocrine Clinical Site
Toronto, Ontario, Canada
Countries
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Related Links
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Other Identifiers
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NBI-98854-HD3006
Identifier Type: -
Identifier Source: org_study_id