Risperidone for the Treatment of Huntington's Disease Involuntary Movements

Korábbi kezelés

• 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)
• Active drug or alcohol abuse or dependence
• Use of an investigational drug in the 30 days prior to the baseline visit

Más betegség

• Allergy or hypersensitivity to risperidone
• Active suicidal ideation or psychiatric condition that in the investigator's opinion would preclude study participation
• History of active (clinically significant) skin disorder that would interfere with sensor adherence
• History of allergic response to adhesives

Laborértékek

• 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)

Egyéb

• Dysphagia that in the investigator's opinion would preclude participation in the study
• Pregnant or breast-feeding
• Any contraindication to MRI (e.g. pacemakers, aneurysm clips, metallic prostheses, shrapnel fragments, claustrophobia)
• Pacemaker, AICD, or other implantable stimulator
• Inability to complete study activities, as determined by the study team
• Clinically significant parkinsonism as determined by expert investigator assessment

• 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