Huntington DiseasePhase 2NCT04201834
Risperidone for the Treatment of Huntington's Disease Involuntary Movements
A Phase 2 study testing Risperidone and BioStamp nPoint device in people with Huntington Disease and Chorea, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Huntington Disease, Chorea
- What is being tested?
- Risperidone and BioStamp nPoint device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2020to 30 Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
URMC Neurology; 919 Westfall Rd, Building C, Suite 100
Rochester, New York, 14618
About this study
Official title: Risperidone for the Treatment of Huntington's Disease Chorea
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.
- Conditions
- Huntington Disease, Chorea
- Being tested
- Risperidone, BioStamp nPoint device
- Medical subject headings
- Huntington Disease, Chorea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
capsule or tablet, 0.5 mg
BioStamp nPoint deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Risperidone; Device: BioStamp nPoint device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to week 12
Secondary outcomes (14)
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.
Measured: Baseline to week 12
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screening to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start13 Aug 2020
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Schneider, MD, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201834
- Sponsor's protocol ID
- 4443
- Status last verified
- Mar 2025
- First submitted
- 13 Dec 2019
- Last updated
- 21 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risperidone for the Treatment of Huntington's Disease Chorea
- ClinicalTrials.gov ID
- NCT04201834
- Acronym / sponsor ID
- 4443
- Conditions
- Huntington Disease, Chorea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Posted 21 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risperidone | Experimental | Drug: Risperidone, Device: BioStamp nPoint deviceParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risperidonecapsule or tablet, 0.5 mg | Drug | Risperidone |
| BioStamp nPoint deviceMC10 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. | Device | Risperidone |
Primary outcome
Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Maximal Chorea (UHDRS TMC) Score
Time frame: Baseline to week 12
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.
14 secondary outcomes
Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Motor Score
Time frame: Baseline to week 12
Change From Baseline in Mean Epworth Sleepiness Scale (ESS)
Time frame: Baseline to week 12
Change From Baseline in Mean Barnes Akathisia Scale Global Clinical Assessment of Akathisia Item Score
Time frame: Baseline to week 12
Number of Participants With a Change in Clinical Global Impression of Change (CGI)
Time frame: Baseline to week 12
Number of Participants With a Change in Patient Global Impression of Change (PGI)
Time frame: Baseline to week 12
Change From Baseline in Mean Quantitative Motor (Q-Motor) Right Hand Speeded Finger Tapping Variability
Time frame: Baseline to week 8
Change From Baseline in Mean Short Problem Behavior Assessment (Short PBA-S) Irritability and Aggression Score
Time frame: Baseline to week 12
Columbia Suicide Severity Rating Scale( C-SSRS)
Time frame: Baseline to week 12
Change From Baseline in Mean Apathy Scale Score
Time frame: Baseline to week 12
Change From Baseline in Mean Hospital Anxiety and Depression Scale-Depression Score
Time frame: Baseline to week 12
Change From Baseline in Mean Montreal Cognitive Assessment
Time frame: Baseline to week 12
Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Independence Scale Score
Time frame: Baseline to week 12
Change From Baseline in Mean Hospital Anxiety and Depression Scale-Anxiety Score
Time frame: Baseline to week 12
Change From Baseline in MC10-Assessed Mean Gait Cadence
Time frame: Screening to Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Huntington Disease
RecruitingPhase 2/3
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Huntington Disease
RecruitingPhase 3
Pridopidine Phase 3 Study in Huntington's Disease
Huntington Disease
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Recruiting
Feasibility and Acceptability of an LLM-based Chatbot for Family Caregivers: Evaluation Study
Caregivers
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Risperidone and BioStamp nPoint device in people with Huntington Disease and Chorea, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Maximal Chorea (UHDRS TMC) Score (time frame: Baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.