Trial · NCT04201834
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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 |
| Secondary | Change From Baseline in Mean Hospital Anxiety and Depression Scale-Depression Score | Baseline to week 12 | This is a self-reported scale that measures anxiety and depression. The Depression sub-score ranges from 0 to 21 with higher scores indicating more depressive symptoms. |
| Secondary | Change From Baseline in Mean Montreal Cognitive Assessment | Baseline to week 12 | The Montreal Cognitive assessment (MoCA) measures cognitive function (attention and concentration, executive functions, memory, language, visuospatial skills, conceptual thinking, calculations, and orientation). The score ranges from 0 to 30. Lower scores indicate worse cognitive function. |
| Secondary | Change From Baseline in Mean Unified Huntington's Disease (HD) Rating Scale Independence Scale Score | Baseline to week 12 | The UHDRS Independence Scale measures level of current functional independence. The score ranges from 10 to 100 with higher scores indicating a higher degree of functional independence. |
| Secondary | Change From Baseline in Mean Hospital Anxiety and Depression Scale-Anxiety Score | Baseline to week 12 | This is a self-reported scale that measures anxiety and depression. The Anxiety sub-score ranges from 0 to 21 with higher scores indicating more anxiety symptoms. |
| Secondary | Change From Baseline in MC10-Assessed Mean Gait Cadence | Screening to Week 8 | MC10 BioStamp nPoint is a wearable biosensor system with accelerometry, gyroscopy, and ECG/EMG capabilities that provides various gait metrics. Gait cadence refers to steps per minute. Higher values indicate more steps per minute. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT04201834/registered