Risperidone for the Treatment of Huntington's Disease Involuntary Movements

Phase 2

Waitlist Available

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing risperidone, a medication that helps control involuntary movements, in patients with Huntington's disease. The study aims to see if risperidone is safe and effective for these patients. Researchers will also use MRI scans and body sensors to measure changes in the patients' movements. Risperidone has been previously reported to improve symptoms in patients with Huntington's disease, including chorea and psychosis.

Eligible Conditions

Huntington's Disease
St. Vitus Dance

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

mean Unified Huntington's Disease (HD) Rating Scale Total Maximal Chorea (UHDRS TMC) score

Secondary study objectives

Columbia Suicide Severity Rating Scale( C-SSRS)

Q-Motor (quantitative motor) assessments of chorea

Short Problem Behavior Assessment form (Short PBA-S)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RisperidoneExperimental Treatment2 Interventions

Participants will initiate risperidone 0.5 mg nightly the day after the baseline visit. Dose assessment will occur at pre-specified intervals during the titration phase (week 2, 3, 4, 6, 7). The investigator will increase the dose by 0.5 mg at the week 2, week 3, week 4, and week 6 visits until either optimal chorea benefit has been obtained, an intolerable adverse event occurs, or the maximum allowable dose (3.0 mg) is reached.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Risperidone

2011

Completed Phase 4

~3550

BioStamp nPoint device

2020

Completed Phase 2

~10