Trial Outcomes & Findings for Risperidone for the Treatment of Huntington's Disease Involuntary Movements (NCT NCT04201834)
NCT ID: NCT04201834
Last Updated: 2025-03-21
Results Overview
The UHDRS is a validated assessment of HD. The TMC score is a subset of the overall motor assessment and measures maximal chorea in seven different body regions. The TMC score ranges from 0 to 28 with higher scores indicating more chorea.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Baseline to week 12
Results posted on
2025-03-21
Participant Flow
Participant milestones
| Measure |
Risperidone
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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|---|---|
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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5
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Risperidone
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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|---|---|
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Overall Study
Screen fail
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1
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Baseline Characteristics
Risperidone for the Treatment of Huntington's Disease Involuntary Movements
Baseline characteristics by cohort
| Measure |
Risperidone
n=5 Participants
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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|---|---|
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Age, Continuous
|
59.4 years
STANDARD_DEVIATION 3.3 • n=99 Participants
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Sex: Female, Male
Female
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2 Participants
n=99 Participants
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Sex: Female, Male
Male
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3 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 12The UHDRS is a validated assessment of HD. The TMC score is a subset of the overall motor assessment and measures maximal chorea in seven different body regions. The TMC score ranges from 0 to 28 with higher scores indicating more chorea.
Outcome measures
| Measure |
Risperidone
n=5 Participants
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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|---|---|
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Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Maximal Chorea (UHDRS TMC) Score
|
-2.4 score on a scale
Interval -7.6 to 2.8
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SECONDARY outcome
Timeframe: Baseline to week 12The UHDRS total motor score measures motor function. The score ranges from 0-124 . Higher total scores indicate worse motor function.
Outcome measures
| Measure |
Risperidone
n=5 Participants
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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|---|---|
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Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Motor Score
|
-.02 score on a scale
Interval -5.5 to 5.1
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SECONDARY outcome
Timeframe: Baseline to week 12This tool measures excessive daytime sleepiness with higher scores indicating worse health outcomes. The scale range is 0 to 24.
Outcome measures
| Measure |
Risperidone
n=5 Participants
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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Change From Baseline in Mean Epworth Sleepiness Scale (ESS)
|
1.2 score on a scale
Interval -2.0 to 4.4
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SECONDARY outcome
Timeframe: Baseline to week 12This tool measures drug-induced akathisia by objective observation and subjective questions. The Global Clinical Assessment of Akathisia Item score ranges from 0 to 5 with higher scores indicating more severe akathisia.
Outcome measures
| Measure |
Risperidone
n=5 Participants
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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|---|---|
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Change From Baseline in Mean Barnes Akathisia Scale Global Clinical Assessment of Akathisia Item Score
|
-0.2 score on a scale
Interval -1.2 to 0.8
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SECONDARY outcome
Timeframe: Baseline to week 12This tool is a observer-rated scale that measures impression of severity and change. It is rated on a 7 point scale from 1(very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Risperidone
n=5 Participants
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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Number of Participants With a Change in Clinical Global Impression of Change (CGI)
Minimally Improved
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3 Participants
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Number of Participants With a Change in Clinical Global Impression of Change (CGI)
No Change
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1 Participants
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Number of Participants With a Change in Clinical Global Impression of Change (CGI)
Minimally Worse
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1 Participants
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SECONDARY outcome
Timeframe: Baseline to week 12Population: PGI data were missing for one participant.
This tool is a patient related scale that measures impression of change on a 7 point scale from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Risperidone
n=4 Participants
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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|---|---|
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Number of Participants With a Change in Patient Global Impression of Change (PGI)
Minimally Improved
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3 Participants
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Number of Participants With a Change in Patient Global Impression of Change (PGI)
Minimally Worse
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1 Participants
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SECONDARY outcome
Timeframe: Baseline to week 8The Q-motor tool uses force transducers and a grip device to measure chorea completing four different tasks that assess fine motor finger and foot tapping speed, pronation/supination and gripping strength. With finger tapping inter-onset interval variability, which is measured in seconds, lower values indicate less irregularity and higher values more irregularity.
Outcome measures
| Measure |
Risperidone
n=5 Participants
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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|---|---|
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Change From Baseline in Mean Quantitative Motor (Q-Motor) Right Hand Speeded Finger Tapping Variability
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-0.04 seconds
Interval -0.09 to 0.01
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SECONDARY outcome
Timeframe: Baseline to week 12This tool measures different behavioral problems which are rated for both severity and frequency on a 5 point scale; severity and frequency ratings are then multiplied to provide an overall score for each symptom. The range for the composite Irritability and Aggression score is 0-32. Higher scores indicate greater difficulties.
Outcome measures
| Measure |
Risperidone
n=5 Participants
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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|---|---|
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Change From Baseline in Mean Short Problem Behavior Assessment (Short PBA-S) Irritability and Aggression Score
|
3.4 score on a scale
Interval 0.8 to 6.0
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SECONDARY outcome
Timeframe: Baseline to week 12The number of participants expressing suicidal ideations will be determined by answering yes to any of the following questions: Have you wished you were dead or wished you could go to sleep and not wake up?, Have you actually had any thoughts of killing yourself?, Have you been thinking about how you might do this?, Have you had these thoughts and had some intention of acting on them?, Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan? All questions require only a yes or no response. There is no numerical scoring or rating.
Outcome measures
| Measure |
Risperidone
n=5 Participants
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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Columbia Suicide Severity Rating Scale( C-SSRS)
Suicidal Ideation - Yes
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0 Participants
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Columbia Suicide Severity Rating Scale( C-SSRS)
Suicidal Ideation - No
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5 Participants
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SECONDARY outcome
Timeframe: Baseline to week 12This tool measures the presence and severity of apathy. The range is 0 to 42 with higher scores indicating worse health outcomes
Outcome measures
| Measure |
Risperidone
n=5 Participants
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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|---|---|
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Change From Baseline in Mean Apathy Scale Score
|
0.8 score on a scale
Interval -11.4 to 12.9
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SECONDARY outcome
Timeframe: Baseline to week 12This is a self-reported scale that measures anxiety and depression. The Depression sub-score ranges from 0 to 21 with higher scores indicating more depressive symptoms.
Outcome measures
| Measure |
Risperidone
n=5 Participants
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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|---|---|
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Change From Baseline in Mean Hospital Anxiety and Depression Scale-Depression Score
|
-1.0 score on a scale
Interval -3.2 to 1.2
|
SECONDARY outcome
Timeframe: Baseline to week 12The Montreal Cognitive assessment (MoCA) measures cognitive function (attention and concentration, executive functions, memory, language, visuospatial skills, conceptual thinking, calculations, and orientation). The score ranges from 0 to 30. Lower scores indicate worse cognitive function.
Outcome measures
| Measure |
Risperidone
n=5 Participants
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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|---|---|
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Change From Baseline in Mean Montreal Cognitive Assessment
|
-0.6 score on a scale
Interval -3.6 to 2.4
|
SECONDARY outcome
Timeframe: Baseline to week 12The UHDRS Independence Scale measures level of current functional independence. The score ranges from 10 to 100 with higher scores indicating a higher degree of functional independence.
Outcome measures
| Measure |
Risperidone
n=5 Participants
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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|---|---|
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Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Independence Scale Score
|
4.0 score on a scale
Interval -7.1 to 15.1
|
SECONDARY outcome
Timeframe: Baseline to week 12This is a self-reported scale that measures anxiety and depression. The Anxiety sub-score ranges from 0 to 21 with higher scores indicating more anxiety symptoms.
Outcome measures
| Measure |
Risperidone
n=5 Participants
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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|---|---|
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Change From Baseline in Mean Hospital Anxiety and Depression Scale-Anxiety Score
|
-1.4 score on a scale
Interval -4.6 to 1.8
|
SECONDARY outcome
Timeframe: Screening to Week 8Population: Sensor data were missing for one participant.
MC10 BioStamp nPoint is a wearable biosensor system with accelerometry, gyroscopy, and ECG/EMG capabilities that provides various gait metrics. Gait cadence refers to steps per minute. Higher values indicate more steps per minute.
Outcome measures
| Measure |
Risperidone
n=4 Participants
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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|---|---|
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Change From Baseline in MC10-Assessed Mean Gait Cadence
|
0.6 steps per minute
Interval -7.5 to 8.8
|
Adverse Events
Risperidone
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Risperidone
n=5 participants at risk
Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.
Risperidone: capsule or tablet, 0.5 mg
BioStamp nPoint device: MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
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|---|---|
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Cardiac disorders
Prolonged QTc Interval
|
20.0%
1/5 • 12 weeks
Our definitions of adverse events and serious adverse events is consistence with the definitions that are provided by clinicaltrials.gov. The recording of adverse events began once the participant signed informed consent and continued until the participant completed the study or withdrew from participation.
|
|
Congenital, familial and genetic disorders
Tics
|
20.0%
1/5 • 12 weeks
Our definitions of adverse events and serious adverse events is consistence with the definitions that are provided by clinicaltrials.gov. The recording of adverse events began once the participant signed informed consent and continued until the participant completed the study or withdrew from participation.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • 12 weeks
Our definitions of adverse events and serious adverse events is consistence with the definitions that are provided by clinicaltrials.gov. The recording of adverse events began once the participant signed informed consent and continued until the participant completed the study or withdrew from participation.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • 12 weeks
Our definitions of adverse events and serious adverse events is consistence with the definitions that are provided by clinicaltrials.gov. The recording of adverse events began once the participant signed informed consent and continued until the participant completed the study or withdrew from participation.
|
|
Gastrointestinal disorders
Dry Mouth
|
20.0%
1/5 • 12 weeks
Our definitions of adverse events and serious adverse events is consistence with the definitions that are provided by clinicaltrials.gov. The recording of adverse events began once the participant signed informed consent and continued until the participant completed the study or withdrew from participation.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • 12 weeks
Our definitions of adverse events and serious adverse events is consistence with the definitions that are provided by clinicaltrials.gov. The recording of adverse events began once the participant signed informed consent and continued until the participant completed the study or withdrew from participation.
|
|
Injury, poisoning and procedural complications
Fall
|
40.0%
2/5 • 12 weeks
Our definitions of adverse events and serious adverse events is consistence with the definitions that are provided by clinicaltrials.gov. The recording of adverse events began once the participant signed informed consent and continued until the participant completed the study or withdrew from participation.
|
|
Injury, poisoning and procedural complications
Hyperemia
|
20.0%
1/5 • 12 weeks
Our definitions of adverse events and serious adverse events is consistence with the definitions that are provided by clinicaltrials.gov. The recording of adverse events began once the participant signed informed consent and continued until the participant completed the study or withdrew from participation.
|
|
Nervous system disorders
Somnolence
|
20.0%
1/5 • 12 weeks
Our definitions of adverse events and serious adverse events is consistence with the definitions that are provided by clinicaltrials.gov. The recording of adverse events began once the participant signed informed consent and continued until the participant completed the study or withdrew from participation.
|
|
Nervous system disorders
Anxiety
|
20.0%
1/5 • 12 weeks
Our definitions of adverse events and serious adverse events is consistence with the definitions that are provided by clinicaltrials.gov. The recording of adverse events began once the participant signed informed consent and continued until the participant completed the study or withdrew from participation.
|
|
Cardiac disorders
Tachycardia
|
20.0%
1/5 • 12 weeks
Our definitions of adverse events and serious adverse events is consistence with the definitions that are provided by clinicaltrials.gov. The recording of adverse events began once the participant signed informed consent and continued until the participant completed the study or withdrew from participation.
|
|
Injury, poisoning and procedural complications
Fracture
|
20.0%
1/5 • 12 weeks
Our definitions of adverse events and serious adverse events is consistence with the definitions that are provided by clinicaltrials.gov. The recording of adverse events began once the participant signed informed consent and continued until the participant completed the study or withdrew from participation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • 12 weeks
Our definitions of adverse events and serious adverse events is consistence with the definitions that are provided by clinicaltrials.gov. The recording of adverse events began once the participant signed informed consent and continued until the participant completed the study or withdrew from participation.
|
|
Nervous system disorders
Constant throat clearing
|
20.0%
1/5 • 12 weeks
Our definitions of adverse events and serious adverse events is consistence with the definitions that are provided by clinicaltrials.gov. The recording of adverse events began once the participant signed informed consent and continued until the participant completed the study or withdrew from participation.
|
|
Nervous system disorders
Jerky movements - hands, arms, shoulders
|
20.0%
1/5 • 12 weeks
Our definitions of adverse events and serious adverse events is consistence with the definitions that are provided by clinicaltrials.gov. The recording of adverse events began once the participant signed informed consent and continued until the participant completed the study or withdrew from participation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place