Parkinson´s Disease
Conditions
Keywords
Parkinson´s Disease, Kinesia-360™, Kinesia-ONE™, Biosensor
Brief summary
Evaluate the benefits of Kinesia-360™ wearable technology in addition to standard clinical practice on improving Parkinson´s disease motor symptoms, Neupro dosing regimen and adherence to Neupro compared with only standard clinical practice.
Interventions
DEVICEKinesia-ONE™
Kinesia-ONE™ wearable sensor uses a subject-worn finger sensor and iPad mini application (APP) to objectively measure specific motor tasks related to Parkinson's disease symptoms such as tremor, bradykinesia (slowed movements), and dyskinesia (involuntary movements) in the Investigator's office. Subjects should wear the Kinesia-ONE™ device on the most affected side.
DEVICEKinesia-360™
Kinesia-360™ wearable sensor includes a wrist and ankle device, along with a cell phone, which is also APP-based, and is designed for continuous day time monitoring of Parkinson's disease symptoms. Subjects will wear Kinesia-360™ while they go about their daily lives, and symptom severity is continually captured to enable objective assessment of Parkinson's disease symptoms. Subjects should wear the Kinesia-360™ device bands on the most affected side.
DRUGRotigotine
All subjects will start Neupro treatment at a dose of either rotigotine 2 mg/24 h or 4 mg/24 h (according to the disease stage of the subject) which will then be adjusted based on symptom assessment either via standard care alone or via a combination of standard care and evaluation of the recordings made available by the Kinesia wearable technologies.
Sponsors
UCB Biopharma S.P.R.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is newly prescribed Neupro and is expected to commence Neupro treatment. Historical Neupro treatment is permitted * Informed Consent form (ICF) is signed and dated by the subject, before any study-related procedures * Subject is considered reliable and capable of adhering to the protocol, visit schedule, completion of the diary, and using Kinesia devices according to the judgment of the Investigator * Male or female subject, \>=18 years of age at the time of the Screening Visit * Subject has Parkinson's disease, defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: tremor at rest, rigidity or impairment of postural reflexes, and without any other known or suspected cause of Secondary Parkinsonism * Subject experiences motor symptoms associated with Parkinson's disease that are not sufficiently controlled by current therapy. The average of the triplicate resting tremor scores and triplicate finger tapping scores from Kinesia-ONE™ (6 scores in total) must be \>1.0
Exclusion criteria
* Subject is currently participating in any study with an investigational medicinal product or investigational device * Subject has any medical, neurological or psychiatric condition which, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study * Subject with Deep Brain Stimulation (DBS) device implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Neupro Dose Per 24h at Visit 2 (Week 12) | Visit 2 (Week 12) | Daily dose of study medication taken at respective visit. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
The study started to enroll patients in March 2017 and concluded in January 2018.
Pre-assignment details
Participant Flow refers to the Safety Set (SS), which consists of all subjects who received at least 1 dose of Neupro. One subject who received Neupro after screen failing was not considered as treated within the study and, therefore, not included in the SS.
Participants by arm
| Arm | Count |
|---|---|
| Rotigotine + Standard Care 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. | 20 |
| Rotigotine + Standard Care + Kinesia-360™ Wearable Device 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. | 19 |
| Total Title | 39 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
Baseline characteristics
| Characteristic | Rotigotine + Standard Care | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | Total Title |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 14 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Continuous | 69.76 years STANDARD_DEVIATION 7.16 | 67.62 years STANDARD_DEVIATION 9.77 | 68.72 years STANDARD_DEVIATION 8.49 |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other/mixed | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 17 Participants | 19 Participants | 36 Participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 9 / 20 | 10 / 19 |
| serious Total, serious adverse events | 1 / 20 | 1 / 19 |
Outcome results
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.
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Population: The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine + Standard Care FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores | -0.450 Scores on a scale | Standard Error 0.156 |
| Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores | -0.525 Scores on a scale | Standard Error 0.156 |
p-value: =0.7295% CI: [-0.5, 0.35]ANCOVA
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.
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Population: The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine + Standard Care FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score | 0.125 Scores on a scale | Standard Error 0.108 |
| Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score | -0.074 Scores on a scale | Standard Error 0.112 |
p-value: =0.19795% CI: [-0.51, 0.11]ANCOVA
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.
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Population: The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine + Standard Care FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score | 0.083 Scores on a scale | Standard Error 0.242 |
| Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score | -0.009 Scores on a scale | Standard Error 0.238 |
p-value: =0.77795% CI: [-0.75, 0.57]ANCOVA
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.
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Population: The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine + Standard Care FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score | -0.394 Scores on scale | Standard Error 0.16 |
| Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score | -0.389 Scores on scale | Standard Error 0.167 |
p-value: =0.98295% CI: [-0.44, 0.45]ANCOVA
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.
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Population: The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine + Standard Care FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score | 0.119 Scores on a scale | Standard Error 0.19 |
| Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score | -0.147 Scores on a scale | Standard Error 0.188 |
p-value: =0.30695% CI: [-0.79, 0.26]ANCOVA
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.
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Population: The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine + Standard Care FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score | -0.178 Scores on a scale | Standard Error 0.115 |
| Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score | -0.188 Scores on a scale | Standard Error 0.117 |
p-value: =0.94795% CI: [-0.33, 0.31]ANCOVA
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.
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Population: The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine + Standard Care FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score | -0.489 Scores on a scale | Standard Error 0.141 |
| Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score | -0.342 Scores on a scale | Standard Error 0.143 |
p-value: =0.44395% CI: [-0.24, 0.53]ANCOVA
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.
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Population: The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine + Standard Care FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score | -0.240 Scores on a scale | Standard Error 0.123 |
| Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score | -0.167 Scores on a scale | Standard Error 0.122 |
p-value: =0.66395% CI: [-0.26, 0.41]ANCOVA
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.
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Population: The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine + Standard Care FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score | -0.202 Scores on a scale | Standard Error 0.102 |
| Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score | -0.171 Scores on a scale | Standard Error 0.106 |
p-value: =0.81995% CI: [-0.25, 0.31]ANCOVA
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.
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Population: The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine + Standard Care FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score | -0.495 Scores on a scale | Standard Error 0.231 |
| Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score | -0.674 Scores on a scale | Standard Error 0.238 |
p-value: =0.56695% CI: [-0.81, 0.45]ANCOVA
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.
Time frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro)
Population: The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine + Standard Care FAS | Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score | -1.0 Scores on a scale | Standard Error 2.1 |
| Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score | -5.3 Scores on a scale | Standard Error 2 |
p-value: =0.13495% CI: [-10.04, 1.41]ANCOVA
Primary
Neupro Dose Per 24h at Visit 2 (Week 12)
Daily dose of study medication taken at respective visit.
Time frame: Visit 2 (Week 12)
Population: The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine + Standard Care FAS | Neupro Dose Per 24h at Visit 2 (Week 12) | 3.9 mg/24 hr | Standard Deviation 1.7 |
| Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Neupro Dose Per 24h at Visit 2 (Week 12) | 4.8 mg/24 hr | Standard Deviation 1.8 |
Primary
Number of Neupro Dose Changes During the Study
Dose adjustments during study are performed per standard of care.
Time frame: Visit 1 (Week 1) to Visit 2 (Week 12)
Population: The Safety Set (SS) included all subjects who received at least 1 dose of Neupro.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine + Standard Care FAS | Number of Neupro Dose Changes During the Study | 1.8 dose changes | Standard Deviation 1.2 |
| Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Number of Neupro Dose Changes During the Study | 2.8 dose changes | Standard Deviation 1.7 |
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.
Time frame: Visit 1 (Week 1) to Visit 2 (Week 12)
Population: The Safety Set (SS) included all subjects who received at least 1 dose of Neupro.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotigotine + Standard Care FAS | Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study | 5 Participants |
| Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study | 5 Participants |
p-value: =0.87695% CI: [0.23, 5.66]Regression, Logistic
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.
Time frame: Visit 1 (Week 1) to Visit 2 (Week 12)
Population: The Safety Set (SS) included all subjects who received at least 1 dose of Neupro.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotigotine + Standard Care FAS | Number of Subjects With Any Adverse Events During the Course of the Study | 9 Participants |
| Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | Number of Subjects With Any Adverse Events During the Course of the Study | 11 Participants |