NCT04201834CompletedPhase 2
Risperidone for the Treatment of Huntington's Disease Involuntary Movements
Risperidone for the Treatment of Huntington's Disease Chorea
Source: ClinicalTrials.gov · Last updated 21 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 13 Dec 2019
- Start date
- 13 Aug 2020
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- University of Rochester
- Diseases
- Huntington's disease
- NCT number
- NCT04201834
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 6
- From 13 Aug 2020 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| URMC Neurology; 919 Westfall Rd, Building C, Suite 100 Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.