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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
deutetrabenazine tablets
Teva Investigational Site 03
Beijing, China
Teva Investigational Site 02
Beijing, China
Teva Investigational Site 01
Chengdu, China
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).
Time frame: Baseline - Week 16
Number of Participants with Any AEs with severity grade
Time frame: Baseline - Week 16
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Baseline - Week 16
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline - Week 16
Number of Participants with Adverse Events (AEs) leading to treatment reduction, suspension, discontinuation, and/or withdrawal
Time frame: Baseline - Week 16
Number of Participants with AEs in titration phase
Time frame: Baseline - Week 16
Number of Participants with AEs in maintenance phase
Time frame: Baseline - Week 16
Number of Participants with AEs of special interest
Special interest including suicidality, depression, somnolence, QTc prolongation, akathisia, and parkinsonism.
Time frame: Baseline - Week 16
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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).
Time frame: Baseline - Week 16