Real World Effectiveness and Safety of Deutetrabenazine in Adult Chinese Participants With Huntington's Disease (HD) Chorea in China

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.

Study Overview

• Status: Completed
• Conditions: Chorea; Huntington's Disease
• Intervention / Treatment: Drug: Deutetrabenazine

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100053
    • Teva Investigational Site 03
  • Beijing, China, 100070
    • Teva Investigational Site 02
  • Chengdu, China, 610041
    • Teva Investigational Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deutetrabenazine	Drug: Deutetrabenazine; deutetrabenazine tablets; Other Names: AUSTEDO®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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).	Baseline, Week 16

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D LLC
• Investigators: Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Actual): October 24, 2025
• Study Completion (Actual): October 24, 2025

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Genetic Diseases, Inborn; Neurocognitive Disorders; Cognition Disorders; Dementia; Neurodegenerative Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Basal Ganglia Diseases; Dyskinesias; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Huntington Disease; Chorea; deutetrabenazine
• Other Study ID Numbers: TV50717-NDG-40182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes