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

NCT07601516 | Completed Phase 4 FDA Drug

• 1 other identifier: TV50717-NDG-40182
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Huntington's Disease; Chorea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (1)

Deutetrabenazine

EXPERIMENTAL

Drug: Deutetrabenazine

Interventions

Deutetrabenazine DRUG

deutetrabenazine tablets

Also known as: AUSTEDO®

Deutetrabenazine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D LLC: lead

Study Sites (3)

Teva Investigational Site 03

Beijing, 100053, China

Location

Teva Investigational Site 02

Beijing, 100070, China

Location

Teva Investigational Site 01

Chengdu, 610041, China

Location

MeSH Terms

Conditions

Huntington Disease; Chorea

Interventions

deutetrabenazine

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start: February 2, 2024
• Primary Completion: October 24, 2025
• Study Completion: October 24, 2025
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)