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The purpose of this study is to assess the safety and benefit of risperidone for the treatment of chorea (involuntary movements) in Huntington's disease. Risperidone is commonly used in clinical practice to treat chorea, however, it has not been approved by the Food and Drug Administration (FDA) to treat chorea. This study will examine 1) whether the investigators see MRI changes with risperidone treatment and 2) whether sensors applied to the participants body can measure chorea and detect changes in chorea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risperidone | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Drug | capsule or tablet, 0.5 mg |
| |
| BioStamp nPoint device |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Maximal Chorea (UHDRS TMC) Score | 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. | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Motor Score | The UHDRS total motor score measures motor function. The score ranges from 0-124 . Higher total scores indicate worse motor function. | Baseline to week 12 |
| Change From Baseline in Mean Epworth Sleepiness Scale (ESS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| URMC Neurology; 919 Westfall Rd, Building C, Suite 100 | Rochester | New York | 14618 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Maximal Chorea (UHDRS TMC) Score | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to week 12 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged QTc Interval | Cardiac disorders | Systematic Assessment |
Small number of subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruth Schneider, MD | University of Rochester | 585-341-7500 | Ruth_schneider@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2019 | Feb 6, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| D002819 | Chorea |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Outcomes assessor will be masked to the visit.
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| 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. |
|
This tool measures excessive daytime sleepiness with higher scores indicating worse health outcomes. The scale range is 0 to 24. |
| Baseline to week 12 |
| Change From Baseline in Mean Barnes Akathisia Scale Global Clinical Assessment of Akathisia Item Score | This 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. | Baseline to week 12 |
| Number of Participants With a Change in Clinical Global Impression of Change (CGI) | This 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). | Baseline to week 12 |
| Number of Participants With a Change in Patient Global Impression of Change (PGI) | 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). | Baseline to week 12 |
| Change From Baseline in Mean Quantitative Motor (Q-Motor) Right Hand Speeded Finger Tapping Variability | The 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. | Baseline to week 8 |
| Change From Baseline in Mean Short Problem Behavior Assessment (Short PBA-S) Irritability and Aggression Score | This 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. | Baseline to week 12 |
| Columbia Suicide Severity Rating Scale( C-SSRS) | The 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. | Baseline to week 12 |
| Change From Baseline in Mean Apathy Scale Score | This tool measures the presence and severity of apathy. The range is 0 to 42 with higher scores indicating worse health outcomes | Baseline to week 12 |
| Change From Baseline in Mean Hospital Anxiety and Depression Scale-Depression Score | This 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. | Baseline to week 12 |
| Change From Baseline in Mean Montreal Cognitive Assessment | The 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. | Baseline to week 12 |
| Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Independence Scale Score | The 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. | Baseline to week 12 |
| Change From Baseline in Mean Hospital Anxiety and Depression Scale-Anxiety Score | This 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. | Baseline to week 12 |
| Change From Baseline in MC10-Assessed Mean Gait Cadence | 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. | Screening to Week 8 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Motor Score | The UHDRS total motor score measures motor function. The score ranges from 0-124 . Higher total scores indicate worse motor function. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to week 12 |
|
|
|
|
| Secondary | Change From Baseline in Mean Epworth Sleepiness Scale (ESS) | This tool measures excessive daytime sleepiness with higher scores indicating worse health outcomes. The scale range is 0 to 24. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to week 12 |
|
|
|
|
| Secondary | Change From Baseline in Mean Barnes Akathisia Scale Global Clinical Assessment of Akathisia Item Score | This 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to week 12 |
|
|
|
|
| Secondary | Number of Participants With a Change in Clinical Global Impression of Change (CGI) | This 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). | Posted | Count of Participants | Participants | Baseline to week 12 |
|
|
|
| Secondary | Number of Participants With a Change in Patient Global Impression of Change (PGI) | 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). | PGI data were missing for one participant. | Posted | Count of Participants | Participants | Baseline to week 12 |
|
|
|
| Secondary | Change From Baseline in Mean Quantitative Motor (Q-Motor) Right Hand Speeded Finger Tapping Variability | The 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. | Posted | Mean | 95% Confidence Interval | seconds | Baseline to week 8 |
|
|
|
|
| Secondary | Change From Baseline in Mean Short Problem Behavior Assessment (Short PBA-S) Irritability and Aggression Score | This 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to week 12 |
|
|
|
|
| Secondary | Columbia Suicide Severity Rating Scale( C-SSRS) | The 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. | Posted | Count of Participants | Participants | Baseline to week 12 |
|
|
|
| Secondary | Change From Baseline in Mean Apathy Scale Score | This tool measures the presence and severity of apathy. The range is 0 to 42 with higher scores indicating worse health outcomes | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to week 12 |
|
|
|
|
| Secondary | Change From Baseline in Mean Hospital Anxiety and Depression Scale-Depression Score | This 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to week 12 |
|
|
|
|
| Secondary | Change From Baseline in Mean Montreal Cognitive Assessment | The 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to week 12 |
|
|
|
|
| Secondary | Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Independence Scale Score | The 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to week 12 |
|
|
|
|
| Secondary | Change From Baseline in Mean Hospital Anxiety and Depression Scale-Anxiety Score | This 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to week 12 |
|
|
|
|
| Secondary | Change From Baseline in MC10-Assessed Mean Gait Cadence | 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. | Sensor data were missing for one participant. | Posted | Mean | 95% Confidence Interval | steps per minute | Screening to Week 8 |
|
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 5 |
| 5 |
| Tics | Congenital, familial and genetic disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hyperemia | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Nervous system disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Constant throat clearing | Nervous system disorders | Systematic Assessment |
|
| Jerky movements - hands, arms, shoulders | Nervous system disorders | Systematic Assessment |
|
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| D003704 | Dementia |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|