Risperidone for the Treatment of Huntington's Disease Involuntary Movements (NCT04201834) | Clinical Trial Compass
CompletedPhase 2
Risperidone for the Treatment of Huntington's Disease Involuntary Movements
United States6 participantsStarted 2020-08-13
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 fra…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Maximal Chorea (UHDRS TMC) Score