Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT04201834
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04201834
Study Brief:
Protocol Section:
NCT04201834