Trial Outcomes & Findings for Real World Effectiveness and Safety of Deutetrabenazine in Adult Chinese Participants With Huntington's Disease (HD) Chorea in China (NCT NCT07601516)
NCT ID: NCT07601516
Last Updated: 2026-08-27
Results Overview
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).
COMPLETED
PHASE4
50 participants
Baseline, Week 16
2026-08-27
Participant Flow
A total of 50 participants were screened and enrolled in the study. Per prespecified analysis, data were collected for single arm regardless of the dose received.
Participant milestones
| Measure |
Deutetrabenazine
Participants received deutetrabenazine over a 16-week treatment period. The initiation dose for the treatment of Huntington's disease (HD)-associated chorea for most participants was 6 milligrams (mg) daily, with weekly intervals of dose increase in 6 mg increments. The maximum recommended daily doses of deutetrabenazine were 48 mg/day and 36 mg/day for poor cytochrome P450 2D6 (CYP2D6) metabolizer or participants with concomitant use of strong CYP2D6 inhibitors. The duration of titration and the maintenance dose for each participant was based on physicians' clinical judgments in this study.
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|---|---|
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Overall Study
STARTED
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50
|
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Overall Study
Received at Least 1 Dose of Study Drug
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50
|
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Overall Study
Participants in Maintenance Phase
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47
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Overall Study
COMPLETED
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49
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Overall Study
NOT COMPLETED
|
1
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Reasons for withdrawal
| Measure |
Deutetrabenazine
Participants received deutetrabenazine over a 16-week treatment period. The initiation dose for the treatment of Huntington's disease (HD)-associated chorea for most participants was 6 milligrams (mg) daily, with weekly intervals of dose increase in 6 mg increments. The maximum recommended daily doses of deutetrabenazine were 48 mg/day and 36 mg/day for poor cytochrome P450 2D6 (CYP2D6) metabolizer or participants with concomitant use of strong CYP2D6 inhibitors. The duration of titration and the maintenance dose for each participant was based on physicians' clinical judgments in this study.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
This baseline measure is reporting data for participants who received deutetrabenazine treatment ≥24 mg/day.
Baseline characteristics by cohort
| Measure |
Deutetrabenazine
n=50 Participants
Participants received deutetrabenazine over a 16-week treatment period. The initiation dose for the treatment of HD-associated chorea for most participants was 6 mg daily, with weekly intervals of dose increase in 6 mg increments. The maximum recommended daily doses of deutetrabenazine were 48 mg/day and 36 mg/day for poor CYP2D6 metabolizer or participants with concomitant use of strong CYP2D6 inhibitors. The duration of titration and the maintenance dose for each participant was based on physicians' clinical judgments in this study.
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|---|---|
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Age, Continuous
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48.9 years
STANDARD_DEVIATION 10.8 • n=50 Participants
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Sex: Female, Male
Female
|
25 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
50 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=50 Participants
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Total Maximal Chorea (TMC) Score in Participants Who Received Deutetrabenazine Treatment ≥24 mg/day
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12.8 score on a scale
STANDARD_DEVIATION 4.3 • n=42 Participants • This baseline measure is reporting data for participants who received deutetrabenazine treatment ≥24 mg/day.
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PRIMARY outcome
Timeframe: Baseline, Week 16Population: The effectiveness analysis set included all enrolled participants who received deutetrabenazine, and had at least 1 post-baseline assessment of the TMC score. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Per prespecified analysis, data were collected for single arm regardless of the dose received.
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).
Outcome measures
| Measure |
Deutrabenazine
n=41 Participants
Participants received deutetrabenazine over a 16-week treatment period. The initiation dose for the treatment of HD-associated chorea for most participants was 6 mg daily, with weekly intervals of dose increase in 6 mg increments. The maximum recommended daily doses of deutetrabenazine were 48 mg/day and 36 mg/day for poor CYP2D6 metabolizer or participants with concomitant use of strong CYP2D6 inhibitors. The duration of titration and the maintenance dose for each participant was based on physicians' clinical judgments in this study.
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|---|---|
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Change From Baseline in TMC Score in Participants Receiving ≥24 mg/Day
|
-4.2 score on a scale
Standard Deviation 2.6
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SECONDARY outcome
Timeframe: Baseline up to Week 16Population: 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. Per prespecified analysis, data were collected for single arm regardless of the dose received.
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.
Outcome measures
| Measure |
Deutrabenazine
n=50 Participants
Participants received deutetrabenazine over a 16-week treatment period. The initiation dose for the treatment of HD-associated chorea for most participants was 6 mg daily, with weekly intervals of dose increase in 6 mg increments. The maximum recommended daily doses of deutetrabenazine were 48 mg/day and 36 mg/day for poor CYP2D6 metabolizer or participants with concomitant use of strong CYP2D6 inhibitors. The duration of titration and the maintenance dose for each participant was based on physicians' clinical judgments in this study.
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|---|---|
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Number of Participants With Any Adverse Events (AEs) By Severity Grade
Grade 3
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1 Participants
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|
Number of Participants With Any Adverse Events (AEs) By Severity Grade
Grade 1
|
17 Participants
|
|
Number of Participants With Any Adverse Events (AEs) By Severity Grade
Grade 2
|
7 Participants
|
|
Number of Participants With Any Adverse Events (AEs) By Severity Grade
Grade 4
|
1 Participants
|
|
Number of Participants With Any Adverse Events (AEs) By Severity Grade
Grade 5
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0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: 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.
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.
Outcome measures
| Measure |
Deutrabenazine
n=50 Participants
Participants received deutetrabenazine over a 16-week treatment period. The initiation dose for the treatment of HD-associated chorea for most participants was 6 mg daily, with weekly intervals of dose increase in 6 mg increments. The maximum recommended daily doses of deutetrabenazine were 48 mg/day and 36 mg/day for poor CYP2D6 metabolizer or participants with concomitant use of strong CYP2D6 inhibitors. The duration of titration and the maintenance dose for each participant was based on physicians' clinical judgments in this study.
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|---|---|
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Number of Participants With Serious Adverse Events (SAEs)
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2 Participants
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SECONDARY outcome
Timeframe: Baseline up to Week 16Population: 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.
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.
Outcome measures
| Measure |
Deutrabenazine
n=50 Participants
Participants received deutetrabenazine over a 16-week treatment period. The initiation dose for the treatment of HD-associated chorea for most participants was 6 mg daily, with weekly intervals of dose increase in 6 mg increments. The maximum recommended daily doses of deutetrabenazine were 48 mg/day and 36 mg/day for poor CYP2D6 metabolizer or participants with concomitant use of strong CYP2D6 inhibitors. The duration of titration and the maintenance dose for each participant was based on physicians' clinical judgments in this study.
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|---|---|
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Number of Participants With Treatment-related AEs
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12 Participants
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SECONDARY outcome
Timeframe: Baseline up to Week 16Population: 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.
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.
Outcome measures
| Measure |
Deutrabenazine
n=50 Participants
Participants received deutetrabenazine over a 16-week treatment period. The initiation dose for the treatment of HD-associated chorea for most participants was 6 mg daily, with weekly intervals of dose increase in 6 mg increments. The maximum recommended daily doses of deutetrabenazine were 48 mg/day and 36 mg/day for poor CYP2D6 metabolizer or participants with concomitant use of strong CYP2D6 inhibitors. The duration of titration and the maintenance dose for each participant was based on physicians' clinical judgments in this study.
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|---|---|
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Number of Participants With AEs Leading to Dose Reduction, Interruption, Treatment Discontinuation, and Study Withdrawal
AEs Leading to Dose Reduction
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9 Participants
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Number of Participants With AEs Leading to Dose Reduction, Interruption, Treatment Discontinuation, and Study Withdrawal
AEs Leading to Dose Interruption
|
2 Participants
|
|
Number of Participants With AEs Leading to Dose Reduction, Interruption, Treatment Discontinuation, and Study Withdrawal
AEs Leading to Treatment Discontinuation
|
0 Participants
|
|
Number of Participants With AEs Leading to Dose Reduction, Interruption, Treatment Discontinuation, and Study Withdrawal
AEs Leading to Study Withdrawal
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: 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.
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.
Outcome measures
| Measure |
Deutrabenazine
n=50 Participants
Participants received deutetrabenazine over a 16-week treatment period. The initiation dose for the treatment of HD-associated chorea for most participants was 6 mg daily, with weekly intervals of dose increase in 6 mg increments. The maximum recommended daily doses of deutetrabenazine were 48 mg/day and 36 mg/day for poor CYP2D6 metabolizer or participants with concomitant use of strong CYP2D6 inhibitors. The duration of titration and the maintenance dose for each participant was based on physicians' clinical judgments in this study.
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|---|---|
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Number of Participants With AEs in Titration Phase
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17 Participants
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SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The safety analysis set included all enrolled participants who received at least 1 dose of deutetrabenazine. Here, 'Overall number of participants analyzed' = participants entered in maintenance phase. Per prespecified analysis, data were collected for single arm regardless of the dose received.
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.
Outcome measures
| Measure |
Deutrabenazine
n=47 Participants
Participants received deutetrabenazine over a 16-week treatment period. The initiation dose for the treatment of HD-associated chorea for most participants was 6 mg daily, with weekly intervals of dose increase in 6 mg increments. The maximum recommended daily doses of deutetrabenazine were 48 mg/day and 36 mg/day for poor CYP2D6 metabolizer or participants with concomitant use of strong CYP2D6 inhibitors. The duration of titration and the maintenance dose for each participant was based on physicians' clinical judgments in this study.
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|---|---|
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Number of Participants With AEs in Maintenance Phase
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5 Participants
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SECONDARY outcome
Timeframe: Baseline up to Week 16Population: 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.
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.
Outcome measures
| Measure |
Deutrabenazine
n=50 Participants
Participants received deutetrabenazine over a 16-week treatment period. The initiation dose for the treatment of HD-associated chorea for most participants was 6 mg daily, with weekly intervals of dose increase in 6 mg increments. The maximum recommended daily doses of deutetrabenazine were 48 mg/day and 36 mg/day for poor CYP2D6 metabolizer or participants with concomitant use of strong CYP2D6 inhibitors. The duration of titration and the maintenance dose for each participant was based on physicians' clinical judgments in this study.
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|---|---|
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Number of Participants With AEs of Special Interest
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The effectiveness analysis set included all enrolled participants who received deutetrabenazine, and had at least 1 post-baseline assessment of the TMC score. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Per prespecified analysis, data were collected for single arm regardless of the dose received.
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).
Outcome measures
| Measure |
Deutrabenazine
n=49 Participants
Participants received deutetrabenazine over a 16-week treatment period. The initiation dose for the treatment of HD-associated chorea for most participants was 6 mg daily, with weekly intervals of dose increase in 6 mg increments. The maximum recommended daily doses of deutetrabenazine were 48 mg/day and 36 mg/day for poor CYP2D6 metabolizer or participants with concomitant use of strong CYP2D6 inhibitors. The duration of titration and the maintenance dose for each participant was based on physicians' clinical judgments in this study.
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|---|---|
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Change From Baseline in TMC Score in All Participants Regardless of Study Drug Dose
|
-3.9 score on a scale
Standard Deviation 2.9
|
Adverse Events
Deutrabenazine
Serious adverse events
| Measure |
Deutrabenazine
n=50 participants at risk
Participants received deutetrabenazine over a 16-week treatment period. The initiation dose for the treatment of HD-associated chorea for most participants was 6 mg daily, with weekly intervals of dose increase in 6 mg increments. The maximum recommended daily doses of deutetrabenazine were 48 mg/day and 36 mg/day for poor CYP2D6 metabolizer or participants with concomitant use of strong CYP2D6 inhibitors. The duration of titration and the maintenance dose for each participant was based on physicians' clinical judgments in this study.
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|---|---|
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Gastrointestinal disorders
Pancreatitis acute
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
1/50 • Baseline up to Week 16
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.
|
Other adverse events
| Measure |
Deutrabenazine
n=50 participants at risk
Participants received deutetrabenazine over a 16-week treatment period. The initiation dose for the treatment of HD-associated chorea for most participants was 6 mg daily, with weekly intervals of dose increase in 6 mg increments. The maximum recommended daily doses of deutetrabenazine were 48 mg/day and 36 mg/day for poor CYP2D6 metabolizer or participants with concomitant use of strong CYP2D6 inhibitors. The duration of titration and the maintenance dose for each participant was based on physicians' clinical judgments in this study.
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|---|---|
|
Ear and labyrinth disorders
Hypoacusis
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
General disorders
Gait disturbance
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Infections and infestations
Folliculitis
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Investigations
Weight increased
|
4.0%
2/50 • Baseline up to Week 16
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Nervous system disorders
Akathisia
|
6.0%
3/50 • Baseline up to Week 16
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.
|
|
Nervous system disorders
Dizziness
|
4.0%
2/50 • Baseline up to Week 16
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.
|
|
Nervous system disorders
Drooling
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Nervous system disorders
Dystonia
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Nervous system disorders
Hypersomnia
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Nervous system disorders
Lethargy
|
4.0%
2/50 • Baseline up to Week 16
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.
|
|
Nervous system disorders
Somnolence
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Psychiatric disorders
Dysphoria
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Psychiatric disorders
Neuropsychological symptoms
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Psychiatric disorders
Suicidal ideation
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.0%
1/50 • Baseline up to Week 16
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/50 • Baseline up to Week 16
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.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products R&D LLC
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER