Risperidone for the Treatment of Huntington's Disease Involuntary Movements
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
capsule or tablet, 0.5 mg
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- mean Unified Huntington's Disease (HD) Rating Scale Total Maximal Chorea (UHDRS TMC) score [week 12]
The UHDRS is a validated assessment of HD. The complete total maximal chorea score is a subset of the overall motor assessment and measures maximal chorea with scores from 0 to 4 with higher scores indicating more chorea.
Secondary Outcome Measures
- mean Unified Huntington's Disease (HD)Rating Scale total scores [Screening to week 12]
The total UHDRS measures motor, cognitive, behavioral, functional, and total functional capacity. The score ranges from 0 to 161. Higher total scores indicate worse health outcomes.
- mean Epworth Sleepiness Scale (ESS) [Baseline to week 12]
This tool measures excessive daytime sleepiness with higher scores indicating worse health outcomes. The scale range is 0 to 24.
- mean Barnes Akathisia Scale [Baseline to week 12]
This tool measures drug-induced akathisia by objective observation and subjective questions. The scale range is 0 to 12 with higher scores indicating akathisia.
- mean clinical global impression of change (CGI) [Baseline to week 12]
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). Higher score indicates no change.
- mean patient global impression of change [Baseline to week 12]
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). A higher score indicates no change.
- Chorea Index as measured by BioStamp nPoint device [Screening to week 8]
The average amount of chorea measured using the BioStamp nPoint device will be determined. Higher score indicates greater degree of chorea.
- Q-Motor (quantitative motor) assessments of chorea [Baseline to week 8]
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.
- Short Problem Behavior Assessment form (Short PBA-S) [Baseline to week 12]
This tool measures different behavioural 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 is 0 to 132. Higher scores indicate worse health outcomes.
- Columbia Suicide Severity Rating Scale( C-SSRS) [Baseline to week 12]
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.
- mean Apathy Scale [Baseline to week 12]
This tool measures the presence and severity of apathy. The range is 0 to 42 with higher scores indicating worse health outcomes
- mean hospital anxiety and depression scale [Baseline to week 12]
This is a self-reported scale that measures anxiety and depression and ranges from 0 to 21 with a lower score indicating better health outcomes.
- mean Montreal Cognitive assessment [Baseline visit only]
The Montreal Cognitive assessment (MoCA) measures mild cognitive dysfunction. The total possible score is 30 points; a score of 26 or above is considered normal.
- mean Unified Huntington's Disease(HD) Rating Scale Independence rating [screening to week 12]
the UHDRS component measures level of current independence. It ranges from 10 to 100 with higher scores indicating greater degree of independence.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Manifest HD (Diagnostic Confidence Level 4 + CAG repeat ≥ 37 or family history of HD)
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UHDRS Total Maximal Chorea (TMC) ≥ 8
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UHDRS Total Functional Capacity ≥ 5
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Subject willing and able to provide written informed consent OR legally authorized representative provides written informed consent and subject provides assent*
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Between 18 and 65 years of age
Exclusion Criteria:
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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)*
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Prior non-response to risperidone or intolerability to risperidone (in the investigator's opinion)
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Allergy or hypersensitivity to risperidone
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Dysphagia that in the investigator's opinion would preclude participation in the study
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Active suicidal ideation or psychiatric condition that in the investigator's opinion would preclude study participation
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QTc > 460 msec for women and QTc > 450 msec for men on 12-lead EKG
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History of cardiac arrhythmia or congenital long QT syndrome
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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)
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Active drug or alcohol abuse or dependence
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Pregnant or breast-feeding
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Any contraindication to MRI (e.g. pacemakers, aneurysm clips, metallic prostheses, shrapnel fragments, claustrophobia)
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History of active (clinically significant) skin disorder that would interfere with sensor adherence
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History of allergic response to adhesives
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Pacemaker, AICD, or other implantable stimulator
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Use of an investigational drug in the 30 days prior to the baseline visit
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Inability to complete study activities, as determined by the study team
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Clinically significant parkinsonism as determined by expert investigator assessment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | URMC Neurology; 919 Westfall Rd, Building C, Suite 100 | Rochester | New York | United States | 14618 |
Sponsors and Collaborators
- University of Rochester
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4443