| Primary | Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score | 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. | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro) | | | | ID | Title | Description |
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| OG000 | Rotigotine + Standard Care FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | | OG001 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.0± 2.1
- OG001-5.3± 2.0
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor. | =0.134 | | Mean Difference (Final Values) | -4.31 | | | 2-Sided | 95 | -10.04 | 1.41 | | | The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS). | | Superiority | | |
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| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score | 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. | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Posted | | Least Squares Mean | Standard Error | Scores on scale | | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | | | | ID | Title | Description |
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| OG000 | Rotigotine + Standard Care FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | | OG001 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
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| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score | 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. | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | | | | ID | Title | Description |
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| OG000 | Rotigotine + Standard Care FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | | OG001 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
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| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores | 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. | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | | | | ID | Title | Description |
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| OG000 | Rotigotine + Standard Care FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | | OG001 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
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| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score | 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. | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | | | | ID | Title | Description |
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| OG000 | Rotigotine + Standard Care FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | | OG001 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
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| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score | 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. | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | | | | ID | Title | Description |
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| OG000 | Rotigotine + Standard Care FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | | OG001 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
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| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score | 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. | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | | | | ID | Title | Description |
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| OG000 | Rotigotine + Standard Care FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | | OG001 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
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| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score | 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. | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | | | | ID | Title | Description |
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| OG000 | Rotigotine + Standard Care FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | | OG001 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
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| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score | 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. | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | | | | ID | Title | Description |
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| OG000 | Rotigotine + Standard Care FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | | OG001 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
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| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score | 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. | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | | | | ID | Title | Description |
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| OG000 | Rotigotine + Standard Care FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | | OG001 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
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| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score | 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. | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | | | | ID | Title | Description |
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| OG000 | Rotigotine + Standard Care FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | | OG001 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
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| Primary | Neupro Dose Per 24h at Visit 2 (Week 12) | Daily dose of study medication taken at respective visit. | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Posted | | Mean | Standard Deviation | mg/24 hr | | Visit 2 (Week 12) | | | | ID | Title | Description |
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| OG000 | Rotigotine + Standard Care FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | | OG001 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
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| Primary | Number of Neupro Dose Changes During the Study | Dose adjustments during study are performed per standard of care. | The Safety Set (SS) included all subjects who received at least 1 dose of Neupro. | Posted | | Mean | Standard Deviation | dose changes | | Visit 1 (Week 1) to Visit 2 (Week 12) | | | | ID | Title | Description |
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| OG000 | Rotigotine + Standard Care SS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | | OG001 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
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| Primary | Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study | Number of subjects who discontinued Neupro Treatment were recorded. | The Safety Set (SS) included all subjects who received at least 1 dose of Neupro. | Posted | | Count of Participants | | Participants | | Visit 1 (Week 1) to Visit 2 (Week 12) | | | | ID | Title | Description |
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| OG000 | Rotigotine + Standard Care SS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | | OG001 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
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| Secondary | Number of Subjects With Any Adverse Events During the Course of the Study | 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. | The Safety Set (SS) included all subjects who received at least 1 dose of Neupro. | Posted | | Count of Participants | | Participants | | Visit 1 (Week 1) to Visit 2 (Week 12) | | | | ID | Title | Description |
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| OG000 | Rotigotine + Standard Care SS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | | OG001 | Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
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