Clinical trial NCT04201834: Risperidone for the Treatment of Huntington's Disease Involuntary Movements
Official title: Risperidone for the Treatment of Huntington's Disease Chorea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Huntington Disease
Chorea
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Maximal Chorea (UHDRS TMC) Score
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Motor Score
timeFrame: Baseline to week 12
measure: Change From Baseline in Mean Epworth Sleepiness Scale (ESS)
timeFrame: Baseline to week 12
measure: Change From Baseline in Mean Barnes Akathisia Scale Global Clinical Assessment of Akathisia Item Score
timeFrame: Baseline to week 12
measure: Number of Participants With a Change in Clinical Global Impression of Change (CGI)
timeFrame: Baseline to week 12
measure: Number of Participants With a Change in Patient Global Impression of Change (PGI)
timeFrame: Baseline to week 12
measure: Change From Baseline in Mean Quantitative Motor (Q-Motor) Right Hand Speeded Finger Tapping Variability
timeFrame: Baseline to week 8
measure: Change From Baseline in Mean Short Problem Behavior Assessment (Short PBA-S) Irritability and Aggression Score
timeFrame: Baseline to week 12
measure: Columbia Suicide Severity Rating Scale( C-SSRS)
timeFrame: Baseline to week 12
measure: Change From Baseline in Mean Apathy Scale Score
timeFrame: Baseline to week 12
measure: Change From Baseline in Mean Hospital Anxiety and Depression Scale-Depression Score
timeFrame: Baseline to week 12
measure: Change From Baseline in Mean Montreal Cognitive Assessment
timeFrame: Baseline to week 12
measure: Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Independence Scale Score
timeFrame: Baseline to week 12
measure: Change From Baseline in Mean Hospital Anxiety and Depression Scale-Anxiety Score
timeFrame: Baseline to week 12
measure: Change From Baseline in MC10-Assessed Mean Gait Cadence
timeFrame: Screening to Week 8
Other outcomes:
Locations:
city: Rochester
country: United States
facility: URMC Neurology; 919 Westfall Rd, Building C, Suite 100
state: New York
Study officials:
References: