Huntington's DiseasePhase 4NCT07601516
Real World Effectiveness and Safety of Deutetrabenazine in Adult Chinese Participants With Huntington's Disease (HD) Chorea in China
A Phase 4 study testing Deutetrabenazine in people with Huntington's Disease and Chorea, run by Teva Branded Pharmaceutical Products R&D LLC at 3 sites in China.
Trial summary
The Primary Objective: To evaluate the real-world effectiveness of deutetrabenazine in adult participants with chorea associated with Huntington's disease in China. The Secondary Objectives: To evaluate the real-world safety of deutetrabenazine in adult participants with chorea associated with Huntington's disease in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington's Disease, Chorea
- What is being tested?
- Deutetrabenazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesChina
- Study dates
- 2 Feb 2024to 24 Oct 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with clinically confirmed diagnosis of chorea associated with Huntington's Disease (HD)
- Participants whose baseline total maximal chorea (TMC) score ≥ 8
- Participants who are deutetrabenazine-naïve before study entry or who did not receive deutetrabenazine within 30 days of study entry, and who are about to be treated with deutetrabenazine for chorea associated with HD
- Participants who have provided written consent for the use of personal and medical information for study purposes
Who cannot join
- Participants who have an unstable or serious medical or psychiatric illness at baseline
- Participants with any history of suicidality, untreated or inadequately treated depression
- Participants with certain comorbidities, including hepatic impairment, congenital long QT syndrome, and clinically significant cardiac arrhythmias.
- Participants who received reserpine within 20 days of deutetrabenazine treatment initiation
- Participants who received monoamine oxidase inhibitors within 14 days of deutetrabenazine treatment initiation
- Participants who received vesicular monoamine transporter 2 (VMAT2) inhibitors, e.g., tetrabenazine or valbenazine, within 30 days of deutetrabenazine treatment initiation
- Participants unable to provide a written consent for the study.
- Participants who are participating in another study that includes treatment with an investigational drug and/or intervention at the same time as enrolment in the current study
Trial locations and contacts
3 sites in 1 country.
China3 sites
Teva Investigational Site 03
Beijing, 100053
Teva Investigational Site 02
Beijing, 100070
Teva Investigational Site 01
Chengdu, 610041
About this study
Official title: Real-World Effectiveness and Safety of Deutetrabenazine in Chinese Patients With Chorea Associated With Huntington's Disease.
The Primary Objective: To evaluate the real-world effectiveness of deutetrabenazine in adult participants with chorea associated with Huntington's disease in China.
The Secondary Objectives: To evaluate the real-world safety of deutetrabenazine in adult participants with chorea associated with Huntington's disease in China.
- Conditions
- Huntington's Disease, Chorea
- Being tested
- Deutetrabenazine
- Medical subject headings
- Huntington Disease, Chorea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeutetrabenazineDrug
Also called AUSTEDO®
deutetrabenazine tablets
| Study group | Role | What they receive |
|---|---|---|
| Deutetrabenazine | Experimental | Not described Receives: Drug: Deutetrabenazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in TMC Score in Participants Receiving ≥24 mg/Day
The TMC score was determined from Item 12 of the motor assessment (Part 1) of the UHDRS and quantifies chorea (range, 0-28, lower score indicated less chorea). It was the sum of maximal chorea scores for 7 body regions (face, buccal-oral-lingual, trunk, and 4 extremities), each of which was scored on a scale from 0 to 4 (0, absent; 1, slight or intermittent; 2, mild and common or moderate and intermittent; 3, moderate and common; and 4, marked and prolonged).
Measured: Baseline, Week 16
Secondary outcomes (8)
Number of Participants With Any Adverse Events (AEs) By Severity Grade
AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of AEs recorded as one of following Common Terminology Criteria for Adverse Events (CTCAE) criteria: -Grade 1: Mild; asymptomatic or mild symptoms; clinical/diagnostic observations only; intervention not indicated. -Grade 2: Moderate; local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL) (for example, preparing meals, shopping for groceries or clothes, using telephone). -Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization; disabling; limiting self-care ADL (bathing, dressing, feeding self, using toilet, taking medications, and not bedridden). -Grade 4: Life-threatening; urgent intervention indicated. -Grade 5: Death related to AE. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Baseline up to Week 16
Number of Participants With Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Measured: Baseline up to Week 16
Number of Participants With Treatment-related AEs
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants with treatment-related AEs is reported in this outcome measure. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Measured: Baseline up to Week 16
Number of Participants With AEs Leading to Dose Reduction, Interruption, Treatment Discontinuation, and Study Withdrawal
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs leading to dose reduction, interruption, treatment discontinuation, and study withdrawal is reported in this outcome measure. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Measured: Baseline up to Week 16
Number of Participants With AEs in Titration Phase
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs lasted from titration phase to maintenance phase were considered an AE that occurred in the titration phase. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Measured: Baseline up to Week 16
Number of Participants With AEs in Maintenance Phase
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Measured: Baseline up to Week 16
Number of Participants With AEs of Special Interest
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs of special interest included suicidality, depression, somnolence, QTc prolongation, akathisia, and parkinsonism. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Measured: Baseline up to Week 16
Change From Baseline in TMC Score in All Participants Regardless of Study Drug Dose
The TMC score was determined from Item 12 of the motor assessment (Part 1) of the UHDRS and quantifies chorea (range, 0-28, lower score indicated less chorea). It was the sum of maximal chorea scores for 7 body regions (face, buccal-oral-lingual, trunk, and 4 extremities), each of which was scored on a scale from 0 to 4 (0, absent; 1, slight or intermittent; 2, mild and common or moderate and intermittent; 3, moderate and common; and 4, marked and prolonged).
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start2 Feb 2024
- Primary completion24 Oct 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Huntington's DiseaseStudies of the same condition, open and under way.
- More trials run by Teva Branded Pharmaceutical Products R&D LLCThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601516
- Sponsor's protocol ID
- TV50717-NDG-40182
- Status last verified
- Jul 2026
- First submitted
- 15 May 2026
- Last updated
- 27 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Effectiveness and Safety of Deutetrabenazine in Chinese Patients With Chorea Associated With Huntington's Disease.
- ClinicalTrials.gov ID
- NCT07601516
- Acronym / sponsor ID
- TV50717-NDG-40182
- Conditions
- Huntington's Disease, Chorea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Posted 27 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Primary Objective: To evaluate the real-world effectiveness of deutetrabenazine in adult participants with chorea associated with Huntington's disease in China.
The Secondary Objectives: To evaluate the real-world safety of deutetrabenazine in adult participants with chorea associated with Huntington's disease in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deutetrabenazine | Experimental | Drug: Deutetrabenazine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with clinically confirmed diagnosis of chorea associated with Huntington's Disease (HD)
- Participants whose baseline total maximal chorea (TMC) score ≥ 8
- Participants who are deutetrabenazine-naïve before study entry or who did not receive deutetrabenazine within 30 days of study entry, and who are about to be treated with deutetrabenazine for chorea associated with HD
- Participants who have provided written consent for the use of personal and medical information for study purposes
Key exclusion criteria (8 listed)
- Participants who have an unstable or serious medical or psychiatric illness at baseline
- Participants with any history of suicidality, untreated or inadequately treated depression
- Participants with certain comorbidities, including hepatic impairment, congenital long QT syndrome, and clinically significant cardiac arrhythmias.
- Participants who received reserpine within 20 days of deutetrabenazine treatment initiation
- Participants who received monoamine oxidase inhibitors within 14 days of deutetrabenazine treatment initiation
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 |
|---|---|---|
| DeutetrabenazineAlso: AUSTEDO®deutetrabenazine tablets | Drug | Deutetrabenazine |
Primary outcome
Change From Baseline in TMC Score in Participants Receiving ≥24 mg/Day
Time frame: Baseline, Week 16
The TMC score was determined from Item 12 of the motor assessment (Part 1) of the UHDRS and quantifies chorea (range, 0-28, lower score indicated less chorea). It was the sum of maximal chorea scores for 7 body regions (face, buccal-oral-lingual, trunk, and 4 extremities), each of which was scored on a scale from 0 to 4 (0, absent; 1, slight or intermittent; 2, mild and common or moderate and intermittent; 3, moderate and common; and 4, marked and prolonged).
8 secondary outcomes
Number of Participants With Any Adverse Events (AEs) By Severity Grade
Time frame: Baseline up to Week 16
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Baseline up to Week 16
Number of Participants With Treatment-related AEs
Time frame: Baseline up to Week 16
Number of Participants With AEs Leading to Dose Reduction, Interruption, Treatment Discontinuation, and Study Withdrawal
Time frame: Baseline up to Week 16
Number of Participants With AEs in Titration Phase
Time frame: Baseline up to Week 16
Number of Participants With AEs in Maintenance Phase
Time frame: Baseline up to Week 16
Number of Participants With AEs of Special Interest
Time frame: Baseline up to Week 16
Change From Baseline in TMC Score in All Participants Regardless of Study Drug Dose
Time frame: Baseline, Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
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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.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Deutetrabenazine in people with Huntington's Disease and Chorea, run by Teva Branded Pharmaceutical Products R&D LLC at 3 sites in China.
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 4 inclusion and 8 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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in TMC Score in Participants Receiving ≥24 mg/Day (time frame: Baseline, Week 16). 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 27 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.