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Completed
NCT07601516
Real World Effectiveness and Safety of Deutetrabenazine in Adult Chinese Patients With Huntington's Disease (HD) Chorea in China
Conditions: Huntington's Disease, Chorea
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 50
Sponsor: Teva Branded Pharmaceutical Products R&D LLC
Location: Teva Investigational Site 03 Beijing
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07601516). StuddyBuddy aggregates publicly available trial information.