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

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

The Primary Objective: To evaluate the real-world effectiveness of deutetrabenazine in adult patients with chorea associated with Huntington's disease in China.

The Secondary Objectives: To evaluate the real-world safety of deutetrabenazine in adult patients 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 in Total Maximal Chorea (TMC) Score in participants receiving ≥24 mg/day	TMC score is determined from Item 12 of the motor assessment (Part 1) of the UHDRS and quantifies chorea (range, 0-28, lower score indicates less chorea). It is the sum of maximal chorea scores for seven body regions (face, buccal-oral-lingual, trunk, and four extremities), each of which is 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 AEs with severity grade		Baseline - Week 16
Number of Participants with Serious Adverse Events (SAEs)		Baseline - Week 16
Number of Participants with Treatment Emergent Adverse Events (TEAEs)		Baseline - Week 16
Number of Participants with Adverse Events (AEs) leading to treatment reduction, suspension, discontinuation, and/or withdrawal		Baseline - Week 16
Number of Participants with AEs in titration phase		Baseline - Week 16
Number of Participants with AEs in maintenance phase		Baseline - Week 16
Number of Participants with AEs of special interest	Special interest including suicidality, depression, somnolence, QTc prolongation, akathisia, and parkinsonism.	Baseline - Week 16
Change in Total Maximal Chorea (TMC) Score in all participants regardless of dosage		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): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 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