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Completed

NCT Number: NCT07601516

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Teva Investigational Site 02, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deutetrabenazine

Drug

deutetrabenazine tablets

Other names: AUSTEDO®

Primary outcomes

  1. Change in Total Maximal Chorea (TMC) Score in participants receiving ≥24 mg/day

    Time frame: Baseline - Week 16

    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).

Secondary outcomes

  1. Number of Participants with Any AEs with severity grade

    Time frame: Baseline - Week 16

  2. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: Baseline - Week 16

  3. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Baseline - Week 16

  4. Number of Participants with Adverse Events (AEs) leading to treatment reduction, suspension, discontinuation, and/or withdrawal

    Time frame: Baseline - Week 16

  5. Number of Participants with AEs in titration phase

    Time frame: Baseline - Week 16

  6. Number of Participants with AEs in maintenance phase

    Time frame: Baseline - Week 16

  7. Number of Participants with AEs of special interest

    Time frame: Baseline - Week 16

    Special interest including suicidality, depression, somnolence, QTc prolongation, akathisia, and parkinsonism.

  8. Change in Total Maximal Chorea (TMC) Score in all participants regardless of dosage

    Time frame: Baseline - Week 16

    Unified Huntington's Disease Rating Scale (UHDRS)-Total Maximal Chorea (TMC) score ranging from 0 to 28 with lower score indicating less severity of chorea. TMC score was the sum of maximal chorea scores for seven body regions (face, buccal-oral-lingual, trunk, and four 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).

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 22, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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