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
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 IdentifierNCT04201834
SponsorUniversity of Rochester
Last Modified on24 January 2022

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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