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CompletedNCT04201834Updated Mar 21, 2025Results posted

Risperidone for the Treatment of Huntington's Disease Involuntary Movements

A Phase 2 interventional study of Risperidone and BioStamp nPoint device in Huntington Disease and Chorea, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by University of Rochester · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Huntington Disease
  • Chorea
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Manifest HD (Diagnostic Confidence Level 4 + CAG repeat ≥ 37 or family history of HD)
  • UHDRS Total Maximal Chorea (TMC) ≥ 8
  • UHDRS Total Functional Capacity ≥ 5
  • Subject willing and able to provide written informed consent OR legally authorized representative provides written informed consent and subject provides assent*
  • Between 18 and 65 years of age

Exclusion criteria

Exclusion Criteria:

  • Use of antipsychotic, levodopa, dopamine agonist, monoamine oxidase inhibitor or other disallowed medication in the 30 days prior to the baseline visit (see Section 4.2.5)*
  • Prior non-response to risperidone or intolerability to risperidone (in the investigator's opinion)
  • Allergy or hypersensitivity to risperidone
  • Dysphagia that in the investigator's opinion would preclude participation in the study
  • Active suicidal ideation or psychiatric condition that in the investigator's opinion would preclude study participation
  • QTc > 460 msec for women and QTc > 450 msec for men on 12-lead EKG
  • History of cardiac arrhythmia or congenital long QT syndrome
  • Significant renal impairment (creatinine clearance \< 30 mL/min as estimated by the Cockgroft-Gault formula) or hepatic impairment (AST or ALT > 2.5 times upper limit of normal OR alkaline phosphatase or total bilirubin > 2 times upper limit of normal)
  • Active drug or alcohol abuse or dependence
  • Pregnant or breast-feeding
  • Any contraindication to MRI (e.g. pacemakers, aneurysm clips, metallic prostheses, shrapnel fragments, claustrophobia)
  • History of active (clinically significant) skin disorder that would interfere with sensor adherence
  • History of allergic response to adhesives
  • Pacemaker, AICD, or other implantable stimulator
  • Use of an investigational drug in the 30 days prior to the baseline visit
  • Inability to complete study activities, as determined by the study team
  • Clinically significant parkinsonism as determined by expert investigator assessment
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Risperidone · Device: BioStamp nPoint device

Interventions

  • DrugRisperidone

    capsule or tablet, 0.5 mg

  • DeviceBioStamp 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to week 12

Secondary outcomes

  1. 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.

    Time frame: Baseline to week 12

  2. 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.

    Time frame: Baseline to week 12

  3. 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.

    Time frame: Baseline to week 12

  4. 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).

    Time frame: Baseline to week 12

  5. 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).

    Time frame: Baseline to week 12

  6. 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.

    Time frame: Baseline to week 8

  7. 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.

    Time frame: Baseline to week 12

  8. 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.

    Time frame: Baseline to week 12

  9. 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

    Time frame: Baseline to week 12

  10. 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.

    Time frame: Baseline to week 12

  11. 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.

    Time frame: Baseline to week 12

  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.

    Time frame: Baseline to week 12

  13. 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.

    Time frame: Baseline to week 12

  14. 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.

    Time frame: Screening to Week 8

06

Results

Posted Mar 21, 2025
Limitations and caveats
Small number of subjects.

Participant flow

Participant flow — Overall Study
MilestoneRisperidone
Started6
Completed5
Not completed1
Withdrew: Screen fail1

Outcome measures

PrimaryChange 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.

Time frame:
Baseline to week 12
Reported as:
Mean · score on a scale
Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Maximal Chorea (UHDRS TMC) Score
score on a scaleRisperidone
Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Maximal Chorea (UHDRS TMC) Score-2.4 (-7.6 to 2.8)
Statistical analysis
  • Risperidone · Paired T-Test · p = 0.27
SecondaryChange 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.

Time frame:
Baseline to week 12
Reported as:
Mean · score on a scale
Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Motor Score
score on a scaleRisperidone
Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Motor Score-.02 (-5.5 to 5.1)
Statistical analysis
  • Risperidone · Paired T-Test · p = 0.92
SecondaryChange 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.

Time frame:
Baseline to week 12
Reported as:
Mean · score on a scale
Change From Baseline in Mean Epworth Sleepiness Scale (ESS)
score on a scaleRisperidone
Change From Baseline in Mean Epworth Sleepiness Scale (ESS)1.2 (-2.0 to 4.4)
Statistical analysis
  • Risperidone · Paired T-Test · p = 0.36
SecondaryChange 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.

Time frame:
Baseline to week 12
Reported as:
Mean · score on a scale
Change From Baseline in Mean Barnes Akathisia Scale Global Clinical Assessment of Akathisia Item Score
score on a scaleRisperidone
Change From Baseline in Mean Barnes Akathisia Scale Global Clinical Assessment of Akathisia Item Score-0.2 (-1.2 to 0.8)
Statistical analysis
  • Risperidone · Paired T-Test · p = 0.62
SecondaryNumber 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).

Time frame:
Baseline to week 12
Reported as:
Count of participants · Participants
Number of Participants With a Change in Clinical Global Impression of Change (CGI)
ParticipantsRisperidone
Minimally Improved3
No Change1
Minimally Worse1
SecondaryNumber 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).

Time frame:
Baseline to week 12
Reported as:
Count of participants · Participants
Number of Participants With a Change in Patient Global Impression of Change (PGI)
ParticipantsRisperidone
Minimally Improved3
Minimally Worse1
SecondaryChange 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.

Time frame:
Baseline to week 8
Reported as:
Mean · seconds
Change From Baseline in Mean Quantitative Motor (Q-Motor) Right Hand Speeded Finger Tapping Variability
secondsRisperidone
Change From Baseline in Mean Quantitative Motor (Q-Motor) Right Hand Speeded Finger Tapping Variability-0.04 (-0.09 to 0.01)
Statistical analysis
  • Risperidone · Paired T-Test · p = 0.11
SecondaryChange 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.

Time frame:
Baseline to week 12
Reported as:
Mean · score on a scale
Change From Baseline in Mean Short Problem Behavior Assessment (Short PBA-S) Irritability and Aggression Score
score on a scaleRisperidone
Change From Baseline in Mean Short Problem Behavior Assessment (Short PBA-S) Irritability and Aggression Score3.4 (0.8 to 6.0)
Statistical analysis
  • Risperidone · Paired T-Test · p = 0.02
SecondaryColumbia 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.

Time frame:
Baseline to week 12
Reported as:
Count of participants · Participants
Columbia Suicide Severity Rating Scale( C-SSRS)
ParticipantsRisperidone
Suicidal Ideation - Yes0
Suicidal Ideation - No5
SecondaryChange 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

Time frame:
Baseline to week 12
Reported as:
Mean · score on a scale
Change From Baseline in Mean Apathy Scale Score
score on a scaleRisperidone
Change From Baseline in Mean Apathy Scale Score0.8 (-11.4 to 12.9)
Statistical analysis
  • Risperidone · Paired T-Test · p = 0.86
SecondaryChange 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.

Time frame:
Baseline to week 12
Reported as:
Mean · score on a scale
Change From Baseline in Mean Hospital Anxiety and Depression Scale-Depression Score
score on a scaleRisperidone
Change From Baseline in Mean Hospital Anxiety and Depression Scale-Depression Score-1.0 (-3.2 to 1.2)
Statistical analysis
  • Risperidone · Paired T-Test · p = 0.27
SecondaryChange 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.

Time frame:
Baseline to week 12
Reported as:
Mean · score on a scale
Change From Baseline in Mean Montreal Cognitive Assessment
score on a scaleRisperidone
Change From Baseline in Mean Montreal Cognitive Assessment-0.6 (-3.6 to 2.4)
Statistical analysis
  • Risperidone · Paired T-Test · p = 0.61
SecondaryChange 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.

Time frame:
Baseline to week 12
Reported as:
Mean · score on a scale
Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Independence Scale Score
score on a scaleRisperidone
Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Independence Scale Score4.0 (-7.1 to 15.1)
Statistical analysis
  • Risperidone · Paired T-Test · p = 0.37
SecondaryChange 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.

Time frame:
Baseline to week 12
Reported as:
Mean · score on a scale
Change From Baseline in Mean Hospital Anxiety and Depression Scale-Anxiety Score
score on a scaleRisperidone
Change From Baseline in Mean Hospital Anxiety and Depression Scale-Anxiety Score-1.4 (-4.6 to 1.8)
Statistical analysis
  • Risperidone · Paired T-Test · p = 0.30
SecondaryChange 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.

Time frame:
Screening to Week 8
Reported as:
Mean · steps per minute
Change From Baseline in MC10-Assessed Mean Gait Cadence
steps per minuteRisperidone
Change From Baseline in MC10-Assessed Mean Gait Cadence0.6 (-7.5 to 8.8)
Statistical analysis
  • Risperidone · Paired t-test · p = 0.82

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Risperidone0/5 (0%)0/5 (0%)5/5 (100%)
Most frequent other events
Showing 10 of 15
Most frequent other events
EventRisperidone
FallInjury, poisoning and procedural complications2/5
Prolonged QTc IntervalCardiac disorders1/5
TicsCongenital, familial and genetic disorders1/5
ConstipationGastrointestinal disorders1/5
DiarrheaGastrointestinal disorders1/5
Dry MouthGastrointestinal disorders1/5
VomitingGastrointestinal disorders1/5
HyperemiaInjury, poisoning and procedural complications1/5
SomnolenceNervous system disorders1/5
AnxietyNervous system disorders1/5

Baseline characteristics

Age, Continuous
Age, Continuous(years)Risperidone
Mean59.4 ± 3.3
Sex: Female, Male
Sex: Female, Male(Participants)Risperidone
Female2
Male3
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Risperidone
Hispanic or Latino0
Not Hispanic or Latino5
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Risperidone
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White5
More than one race0
Unknown or Not Reported0
07

Study locations

1 site
  • URMC Neurology; 919 Westfall Rd, Building C, Suite 100
    Rochester, New York 14618, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 7, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Registry details

Key details

Study ID
NCT04201834
Lead sponsor
University of Rochester
Responsible party
Ruth Schneider, MD (Assistant Professor, University of Rochester) — Principal investigator
First posted
Dec 17, 2019
Start date
Aug 13, 2020
Primary completion
Dec 30, 2023
Completion
Dec 30, 2023
Results posted
Mar 21, 2025
Last update
Mar 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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