Risperidone for the Treatment of Huntington's Disease Involuntary Movements

Phase 2CompletedNCT04201834

University of Rochester6 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Huntington Disease Chorea

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

URMC Neurology; 919 Westfall Rd, Building C, Suite 100

Rochester, New York, United States

Outcomes

Primary Outcomes

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.