A Phase 4 interventional study of Deutetrabenazine in Huntington's Disease and Chorea, sponsored by Teva Branded Pharmaceutical Products R&D LLC. Completed at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Teva Branded Pharmaceutical Products R&D LLC (part of Teva Pharmaceutical Industries, Ltd.) · Phase 4, Interventional, and Treatment
The Primary Objective: To evaluate the real-world effectiveness of deutetrabenazine in adult participants with chorea associated with Huntington's disease in China.
The Secondary Objectives: To evaluate the real-world safety of deutetrabenazine in adult participants with chorea associated with Huntington's disease in China.
293 studies on the registry are indexed under Huntington Disease; 54 are open to participants now.
This study's enrollment of 50 is above the median of 40 across 207 interventional studies indexed under Huntington Disease.
Browse Huntington Disease studies →Teva Branded Pharmaceutical Products R&D LLC is the lead sponsor of 24 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Deutetrabenazine
deutetrabenazine tablets
Also known as: AUSTEDO®
Change From Baseline in TMC Score in Participants Receiving ≥24 mg/Day
The TMC score was determined from Item 12 of the motor assessment (Part 1) of the UHDRS and quantifies chorea (range, 0-28, lower score indicated less chorea). It was the sum of maximal chorea scores for 7 body regions (face, buccal-oral-lingual, trunk, and 4 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
Number of Participants With Any Adverse Events (AEs) By Severity Grade
AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of AEs recorded as one of following Common Terminology Criteria for Adverse Events (CTCAE) criteria: -Grade 1: Mild; asymptomatic or mild symptoms; clinical/diagnostic observations only; intervention not indicated. -Grade 2: Moderate; local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL) (for example, preparing meals, shopping for groceries or clothes, using telephone). -Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization; disabling; limiting self-care ADL (bathing, dressing, feeding self, using toilet, taking medications, and not bedridden). -Grade 4: Life-threatening; urgent intervention indicated. -Grade 5: Death related to AE. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Baseline up to Week 16
Number of Participants With Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Time frame: Baseline up to Week 16
Number of Participants With Treatment-related AEs
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants with treatment-related AEs is reported in this outcome measure. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Time frame: Baseline up to Week 16
Number of Participants With AEs Leading to Dose Reduction, Interruption, Treatment Discontinuation, and Study Withdrawal
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs leading to dose reduction, interruption, treatment discontinuation, and study withdrawal is reported in this outcome measure. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Time frame: Baseline up to Week 16
Number of Participants With AEs in Titration Phase
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs lasted from titration phase to maintenance phase were considered an AE that occurred in the titration phase. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Time frame: Baseline up to Week 16
Number of Participants With AEs in Maintenance Phase
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Time frame: Baseline up to Week 16
Number of Participants With AEs of Special Interest
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs of special interest included suicidality, depression, somnolence, QTc prolongation, akathisia, and parkinsonism. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Time frame: Baseline up to Week 16
Change From Baseline in TMC Score in All Participants Regardless of Study Drug Dose
The TMC score was determined from Item 12 of the motor assessment (Part 1) of the UHDRS and quantifies chorea (range, 0-28, lower score indicated less chorea). It was the sum of maximal chorea scores for 7 body regions (face, buccal-oral-lingual, trunk, and 4 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
| Milestone | Deutetrabenazine |
|---|---|
| Started | 50 |
| Received at least 1 dose of study drug | 50 |
| Participants in maintenance phase | 47 |
| Completed | 49 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
The TMC score was determined from Item 12 of the motor assessment (Part 1) of the UHDRS and quantifies chorea (range, 0-28, lower score indicated less chorea). It was the sum of maximal chorea scores for 7 body regions (face, buccal-oral-lingual, trunk, and 4 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).
| score on a scale | Deutrabenazine |
|---|---|
| Change From Baseline in TMC Score in Participants Receiving ≥24 mg/Day | -4.2 ± 2.6 |
AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of AEs recorded as one of following Common Terminology Criteria for Adverse Events (CTCAE) criteria: -Grade 1: Mild; asymptomatic or mild symptoms; clinical/diagnostic observations only; intervention not indicated. -Grade 2: Moderate; local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL) (for example, preparing meals, shopping for groceries or clothes, using telephone). -Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization; disabling; limiting self-care ADL (bathing, dressing, feeding self, using toilet, taking medications, and not bedridden). -Grade 4: Life-threatening; urgent intervention indicated. -Grade 5: Death related to AE. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
| Participants | Deutrabenazine |
|---|---|
| Grade 1 | 17 |
| Grade 2 | 7 |
| Grade 3 | 1 |
| Grade 4 | 1 |
| Grade 5 | 0 |
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
| Participants | Deutrabenazine |
|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | 2 |
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants with treatment-related AEs is reported in this outcome measure. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
| Participants | Deutrabenazine |
|---|---|
| Number of Participants With Treatment-related AEs | 12 |
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs leading to dose reduction, interruption, treatment discontinuation, and study withdrawal is reported in this outcome measure. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
| Participants | Deutrabenazine |
|---|---|
| AEs Leading to Dose Reduction | 9 |
| AEs Leading to Dose Interruption | 2 |
| AEs Leading to Treatment Discontinuation | 0 |
| AEs Leading to Study Withdrawal | 0 |
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs lasted from titration phase to maintenance phase were considered an AE that occurred in the titration phase. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
| Participants | Deutrabenazine |
|---|---|
| Number of Participants With AEs in Titration Phase | 17 |
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
| Participants | Deutrabenazine |
|---|---|
| Number of Participants With AEs in Maintenance Phase | 5 |
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs of special interest included suicidality, depression, somnolence, QTc prolongation, akathisia, and parkinsonism. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
| Participants | Deutrabenazine |
|---|---|
| Number of Participants With AEs of Special Interest | 4 |
The TMC score was determined from Item 12 of the motor assessment (Part 1) of the UHDRS and quantifies chorea (range, 0-28, lower score indicated less chorea). It was the sum of maximal chorea scores for 7 body regions (face, buccal-oral-lingual, trunk, and 4 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).
| score on a scale | Deutrabenazine |
|---|---|
| Change From Baseline in TMC Score in All Participants Regardless of Study Drug Dose | -3.9 ± 2.9 |
Collected over Baseline up to Week 16. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Deutrabenazine | 0/50 (0%) | 2/50 (4%) | 20/50 (40%) |
| Event | Deutrabenazine |
|---|---|
| Pancreatitis acuteGastrointestinal disorders | 1/50 |
| PneumoniaInfections and infestations | 1/50 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 1/50 |
| Event | Deutrabenazine |
|---|---|
| AkathisiaNervous system disorders | 3/50 |
| Weight increasedInvestigations | 2/50 |
| DizzinessNervous system disorders | 2/50 |
| LethargyNervous system disorders | 2/50 |
| HypoacusisEar and labyrinth disorders | 1/50 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 1/50 |
| Noninfective gingivitisGastrointestinal disorders | 1/50 |
| Gait disturbanceGeneral disorders | 1/50 |
| FolliculitisInfections and infestations | 1/50 |
| Decreased appetiteMetabolism and nutrition disorders | 1/50 |
The safety analysis set included all enrolled participants who received at least 1 dose of deutetrabenazine. Per prespecified analysis, data were collected for single arm regardless of the dose received.
| Age, Continuous(years) | Deutetrabenazine |
|---|---|
| Mean | 48.9 ± 10.8 |
| Sex: Female, Male(Participants) | Deutetrabenazine |
|---|---|
| Female | 25 |
| Male | 25 |
| Race (NIH/OMB)(Participants) | Deutetrabenazine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 50 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Total Maximal Chorea (TMC) Score in Participants Who Received Deutetrabenazine Treatment ≥24 mg/day(score on a scale) | Deutetrabenazine |
|---|---|
| Mean | 12.8 ± 4.3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Ran from Feb 2024 to primary completion in Oct 2025, 20 months.
Results were first posted in Aug 2026, 10 months after primary completion.
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Studies of the drug tested here: Deutetrabenazine
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