Real World Effectiveness and Safety of Deutetrabenazine in Adult Chinese Patients With Huntington… (NCT07601516) | Clinical Trial Compass
CompletedPhase 4
Real World Effectiveness and Safety of Deutetrabenazine in Adult Chinese Patients With Huntington's Disease (HD) Chorea in China
China50 participantsStarted 2024-02-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 4 real-world study of deutetrabenazine specifically in Chinese patients with Huntington's disease chorea, could the results be more relevant to my situation than earlier clinical trials, and how does my doctor interpret what the TMC score findings might mean for day-to-day chorea control?
2The trial focused on patients taking at least 24 mg per day of deutetrabenazine — is that dose range something my doctor would consider appropriate for me, and what factors would influence how my dose might be set or adjusted?
3Because this was a real-world observational study rather than a randomized controlled trial, how confident is my doctor in using these safety and effectiveness findings to guide my treatment decisions?
4Are there any safety signals from this study in Chinese adult patients that my doctor thinks are particularly important for me to be aware of before considering deutetrabenazine?
5Given that this trial has already been completed, has my doctor seen or reviewed its published results, and are there standard treatment options for HD chorea I should compare deutetrabenazine against before deciding on a path forward?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Total Maximal Chorea (TMC) Score in participants receiving ≥24 mg/day