Trial · NCT04201834
Risperidone for the Treatment of Huntington's Disease Involuntary Movements
NCT04201834, Phase 2, Completed, University of Rochester; results first posted 2025-03-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Risperidone for the Treatment of Huntington's Disease Involuntary Movements. Trials, record NCT04201834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04201834
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Risperidone for the Treatment of Huntington's Disease Involuntary Movements
- NCT number
- NCT04201834
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Huntington Disease, Chorea
- Interventions
- Risperidone, BioStamp nPoint device
- First posted
- 2019-12-17
- Last updated
- 2025-03-21
- Results first posted
- 2025-03-21
- Limitations and caveats
- Small number of subjects.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Maximal Chorea (UHDRS TMC) Score | Baseline to week 12 | The UHDRS is a validated assessment of HD. The TMC score is a subset of the overall motor assessment and measures maximal chorea in seven different body regions. The TMC score ranges from 0 to 28 with higher scores indicating more chorea. |
| Secondary | Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Motor Score | Baseline to week 12 | The UHDRS total motor score measures motor function. The score ranges from 0-124 . Higher total scores indicate worse motor function. |
| Secondary | Change From Baseline in Mean Epworth Sleepiness Scale (ESS) | Baseline to week 12 | This tool measures excessive daytime sleepiness with higher scores indicating worse health outcomes. The scale range is 0 to 24. |
| Secondary | Change From Baseline in Mean Barnes Akathisia Scale Global Clinical Assessment of Akathisia Item Score | Baseline to week 12 | This tool measures drug-induced akathisia by objective observation and subjective questions. The Global Clinical Assessment of Akathisia Item score ranges from 0 to 5 with higher scores indicating more severe akathisia. |
| Secondary | Number of Participants With a Change in Clinical Global Impression of Change (CGI) | Baseline to week 12 | This tool is a observer-rated scale that measures impression of severity and change. It is rated on a 7 point scale from 1(very much improved) to 7 (very much worse). |
| Secondary | Number of Participants With a Change in Patient Global Impression of Change (PGI) | Baseline to week 12 | This tool is a patient related scale that measures impression of change on a 7 point scale from 1 (very much improved) to 7 (very much worse). |
| Secondary | Change From Baseline in Mean Quantitative Motor (Q-Motor) Right Hand Speeded Finger Tapping Variability | Baseline to week 8 | The Q-motor tool uses force transducers and a grip device to measure chorea completing four different tasks that assess fine motor finger and foot tapping speed, pronation/supination and gripping strength. With finger tapping inter-onset interval variability, which is measured in seconds, lower values indicate less irregularity and higher values more irregularity. |
| Secondary | Change From Baseline in Mean Short Problem Behavior Assessment (Short PBA-S) Irritability and Aggression Score | Baseline to week 12 | This tool measures different behavioral problems which are rated for both severity and frequency on a 5 point scale; severity and frequency ratings are then multiplied to provide an overall score for each symptom. The range for the composite Irritability and Aggression score is 0-32. Higher scores indicate greater difficulties. |
| Secondary | Columbia Suicide Severity Rating Scale( C-SSRS) | Baseline to week 12 | The number of participants expressing suicidal ideations will be determined by answering yes to any of the following questions: Have you wished you were dead or wished you could go to sleep and not wake up?, Have you actually had any thoughts of killing yourself?, Have you been thinking about how you might do this?, Have you had these thoughts and had some intention of acting on them?, Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan? All questions require only a yes or no response. There is no numerical scoring or rating. |
| Secondary | Change From Baseline in Mean Apathy Scale Score | Baseline to week 12 | This tool measures the presence and severity of apathy. The range is 0 to 42 with higher scores indicating worse health outcomes |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Maximal Chorea (UHDRS TMC) Score | Baseline to week 12 | score on a scale | MEAN | |
| SECONDARY | Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Motor Score | Baseline to week 12 | score on a scale | MEAN | |
| SECONDARY | Change From Baseline in Mean Epworth Sleepiness Scale (ESS) | Baseline to week 12 | score on a scale | MEAN | |
| SECONDARY | Change From Baseline in Mean Barnes Akathisia Scale Global Clinical Assessment of Akathisia Item Score | Baseline to week 12 | score on a scale | MEAN | |
| SECONDARY | Number of Participants With a Change in Clinical Global Impression of Change (CGI) | Baseline to week 12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Change in Patient Global Impression of Change (PGI) | Baseline to week 12 | PGI data were missing for one participant. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Mean Quantitative Motor (Q-Motor) Right Hand Speeded Finger Tapping Variability | Baseline to week 8 | seconds | MEAN | |
| SECONDARY | Change From Baseline in Mean Short Problem Behavior Assessment (Short PBA-S) Irritability and Aggression Score | Baseline to week 12 | score on a scale | MEAN | |
| SECONDARY | Columbia Suicide Severity Rating Scale( C-SSRS) | Baseline to week 12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change From Baseline in Mean Apathy Scale Score | Baseline to week 12 | score on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Maximal Chorea (UHDRS TMC) Score | Risperidone | -2.4 | 95% Confidence Interval -7.6 to 2.8 | score on a scale | |
| Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Total Motor Score | Risperidone | -.02 | 95% Confidence Interval -5.5 to 5.1 | score on a scale | |
| Change From Baseline in Mean Epworth Sleepiness Scale (ESS) | Risperidone | 1.2 | 95% Confidence Interval -2.0 to 4.4 | score on a scale | |
| Change From Baseline in Mean Barnes Akathisia Scale Global Clinical Assessment of Akathisia Item Score | Risperidone | -0.2 | 95% Confidence Interval -1.2 to 0.8 | score on a scale | |
| Number of Participants With a Change in Clinical Global Impression of Change (CGI) | Risperidone | Minimally Improved | 3 | Participants | |
| Number of Participants With a Change in Clinical Global Impression of Change (CGI) | Risperidone | No Change | 1 | Participants | |
| Number of Participants With a Change in Clinical Global Impression of Change (CGI) | Risperidone | Minimally Worse | 1 | Participants | |
| Number of Participants With a Change in Patient Global Impression of Change (PGI) | Risperidone | Minimally Improved | 3 | Participants | |
| Number of Participants With a Change in Patient Global Impression of Change (PGI) | Risperidone | Minimally Worse | 1 | Participants | |
| Change From Baseline in Mean Quantitative Motor (Q-Motor) Right Hand Speeded Finger Tapping Variability | Risperidone | -0.04 | 95% Confidence Interval -0.09 to 0.01 | seconds |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Risperidone | 6 | |
| Overall Study | COMPLETED | Risperidone | 5 | |
| Overall Study | NOT COMPLETED | Risperidone | 1 |
Source ClinicalTrials.gov
Adverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Prolonged QTc Interval | Cardiac disorders | Risperidone | 1 | 5 | |
| other | Tics | Congenital, familial and genetic disorders | Risperidone | 1 | 5 | |
| other | Constipation | Gastrointestinal disorders | Risperidone | 1 | 5 | |
| other | Diarrhea | Gastrointestinal disorders | Risperidone | 1 | 5 | |
| other | Dry Mouth | Gastrointestinal disorders | Risperidone | 1 | 5 | |
| other | Vomiting | Gastrointestinal disorders | Risperidone | 1 | 5 | |
| other | Fall | Injury, poisoning and procedural complications | Risperidone | 2 | 5 | |
| other | Hyperemia | Injury, poisoning and procedural complications | Risperidone | 1 | 5 | |
| other | Somnolence | Nervous system disorders | Risperidone | 1 | 5 | |
| other | Anxiety | Nervous system disorders | Risperidone | 1 | 5 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Risperidone | 0 | 5 |
| Total, other adverse events | Risperidone | 5 | 5 |
| Total, serious adverse events | Risperidone | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04201834
GET https://conductscience.org/api/trials/v1/NCT04201834/registered