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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in China

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.

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 groups in NCT07601516
Study groupRoleWhat they receive
DeutetrabenazineExperimentalNot described
Receives: Drug: Deutetrabenazine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted22 May 2026
  2. Study start2 Feb 2024
  3. Primary completion24 Oct 2025
  4. Study completion24 Oct 2025

Resources

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)
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
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.

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.

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