Trial · NCT03103919
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 to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro) | UPDRS Part III has 27 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Each of the 27 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The motor score ranges from 0 to 108, where the maximum score indicates the worse condition. A negative value in change in Unified Parkinson's Disease Rating Scale indicates improvement, whereas a positive value indicates worsening of disease. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. The finger tapping speed scores and resting tremor scores were averaged and provided as one score ranging from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Neupro Dose Per 24h at Visit 2 (Week 12) | Visit 2 (Week 12) | Daily dose of study medication taken at respective visit. |
| Primary | Number of Neupro Dose Changes During the Study | Visit 1 (Week 1) to Visit 2 (Week 12) | Dose adjustments during study are performed per standard of care. |
| Primary | Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study | Visit 1 (Week 1) to Visit 2 (Week 12) | Number of subjects who discontinued Neupro Treatment were recorded. |
| Secondary | Number of Subjects With Any Adverse Events During the Course of the Study | Visit 1 (Week 1) to Visit 2 (Week 12) | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03103919/registered