Risperidone for the Treatment of Huntington's Disease Involuntary Movements

STATUS

Recruiting
End date

Dec 30, 2022
participants needed

12
sponsor

University of Rochester

Updated on 24 January 2022

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risperidone

involuntary movements

chorea

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.

Details

Condition	Huntington Disease, Chorea
Treatment	risperidone, BioStamp nPoint device
Clinical Study Identifier	NCT04201834
Sponsor	University of Rochester
Last Modified on	24 January 2022

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Eligibility		Yes	No	Not Sure
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

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Risperidone for the Treatment of Huntington's Disease Involuntary Movements