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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deutetrabenazine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deutetrabenazine | Drug | deutetrabenazine tablets |
|
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, MD | Teva Branded Pharmaceutical Products R&D LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 03 | Beijing | 100053 | China | |||
| Teva Investigational Site 02 |
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.
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| 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 | 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). | Baseline - Week 16 |
| Beijing |
| 100070 |
| China |
| Teva Investigational Site 01 | Chengdu | 610041 | China |
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| D002819 | Chorea |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000609690 | deutetrabenazine |
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