Chorea, HuntingtonPhase 3NCT04400331
Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease
A Phase 3 study testing Valbenazine in people with Chorea, Huntington, run by Neurocrine Biosciences at 34 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chorea, Huntington
- What is being tested?
- Valbenazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 34 sitesin 2 countries
- Study dates
- 18 Sep 2020to 5 Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either #1 or #2 must be met for inclusion eligibility.
- 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 or early terminated Study NBI-98854-HD3005 for administrative reasons due to COVID-19 (for example, site closure related to COVID-19)
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States31 sites
Neurocrine Clinical Site
Ann Arbor, Michigan, 48105
Neurocrine Clinical Site
Atlanta, Georgia, 30329
Neurocrine Clinical Site
Aurora, Colorado, 80045
Neurocrine Clinical Site
Birmingham, Alabama, 35294
Neurocrine Clinical Site
Boca Raton, Florida, 33486
Neurocrine Clinical Site
Boston, Massachusetts, 02215
Neurocrine Clinical Site
Burlington, Vermont, 05401
Neurocrine Clinical Site
Charleston, South Carolina, 29425
Neurocrine Clinical Site
Charlestown, Massachusetts, 02129
Neurocrine Clinical Site
Chicago, Illinois, 60611
Neurocrine Clinical Site
Chicago, Illinois, 60612
Neurocrine Clinical Site
Columbia, South Carolina, 29203
Neurocrine Clinical Site
Columbus, Ohio, 43221
Neurocrine Clinical Site
Durham, North Carolina, 27705
Neurocrine Clinical Site
Gainesville, Florida, 32608
Neurocrine Clinical Site
Greenville, South Carolina, 29615
Neurocrine Clinical Site
Houston, Texas, 77054
Neurocrine Clinical Site
Indianapolis, Indiana, 46202
Neurocrine Clinical Site
Iowa City, Iowa, 52242
Neurocrine Clinical Site
La Jolla, California, 92037
Neurocrine Clinical Site
Little Rock, Arkansas, 72205
Neurocrine Clinical Site
Louisville, Kentucky, 40202
Neurocrine Clinical Site
Nashville, Tennessee, 37212
Neurocrine Clinical Site
New Orleans, Louisiana, 70121
Neurocrine Clinical Site
Omaha, Nebraska, 68105
Neurocrine Clinical Site
Pittsburgh, Pennsylvania, 15213
Neurocrine Clinical Site
Rochester, New York, 14618
Neurocrine Clinical Site
Toledo, Ohio, 43614
Neurocrine Clinical Site
Washington D.C., District of Columbia, 20007
Neurocrine Clinical Site
Wichita, Kansas, 67226
Neurocrine Clinical Site
Williamsville, New York, 14221
Canada3 sites
Neurocrine Clinical Site
Ottawa, Ontario, K1Y 4E9
Neurocrine Clinical Site
Toronto, Ontario, MK2 1E1
Neurocrine Clinical Site
Vancouver, British Columbia, V6T 2B5
About this study
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.
Read the detailed description
After completion of Week 156/early termination visit, participants in the US will be given the option to continue into an extended maintenance period for up to 104 weeks and participants in Canada will have the option to participate in a separate open-label study (Study NBI-98854-HD3022).
- Conditions
- Chorea, Huntington
- Being tested
- Valbenazine
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValbenazineDrug
Also called NBI-98854
vesicular monoamine transporter 2 (VMAT2) inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Valbenazine | Experimental | Capsule, administered orally once daily. Receives: Drug: Valbenazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to 262 weeks
Secondary outcomes (1)
Change from Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score
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.
Measured: Up to 262 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start18 Sep 2020
- Primary completion5 Nov 2025
- Study completion5 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chorea, HuntingtonStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Huntington Study Group
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400331
- Sponsor's protocol ID
- NBI-98854-HD3006
- Status last verified
- Apr 2026
- First submitted
- 19 May 2020
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease
- ClinicalTrials.gov ID
- NCT04400331
- Acronym / sponsor ID
- NBI-98854-HD3006
- Conditions
- Chorea, Huntington
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Huntington Study Group
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After completion of Week 156/early termination visit, participants in the US will be given the option to continue into an extended maintenance period for up to 104 weeks and participants in Canada will have the option to participate in a separate open-label study (Study NBI-98854-HD3022).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valbenazine | Experimental | Drug: ValbenazineCapsule, administered orally once daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Either #1 or #2 must be met for inclusion eligibility.
- Have participated in Study NBI-98854-HD3005 and
- Did not participate in Study NBI-98854-HD3005 and
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValbenazineAlso: NBI-98854vesicular monoamine transporter 2 (VMAT2) inhibitor | Drug | Valbenazine |
Primary outcome
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 262 weeks
1 secondary outcome
Change from Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score
Time frame: Up to 262 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chorea, Huntington
Recruiting
Feasibility and Acceptability of an LLM-based Chatbot for Family Caregivers: Evaluation Study
Caregivers
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
RecruitingPhase 1
A First-in-human Study of the Effects of SRP-1005 in Participants With Huntington's Disease
Huntington's Disease
RecruitingPhase 3
Pridopidine Phase 3 Study in Huntington's Disease
Huntington Disease
RecruitingPhase 2/3
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Huntington Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
Chief Medical Officer
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valbenazine in people with Chorea, Huntington, run by Neurocrine Biosciences at 34 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to 262 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.