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Trial record 1 of 1 for:    NCT03103919
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Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management

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ClinicalTrials.gov Identifier: NCT03103919
Recruitment Status : Completed
First Posted : April 6, 2017
Results First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Parkinson´s Disease
Interventions Device: Kinesia-ONE™
Device: Kinesia-360™
Drug: Rotigotine
Enrollment 40
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.
Arm/Group Title Rotigotine + Standard Care Rotigotine + Standard Care + Kinesia-360™ Wearable Device
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 20 19
Completed 18 17
Not Completed 2 2
Reason Not Completed
Adverse Event             2             2
Arm/Group Title Rotigotine + Standard Care Rotigotine + Standard Care + Kinesia-360™ Wearable Device Total Title
Hide Arm/Group Description 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. 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. [Not Specified]
Overall Number of Baseline Participants 20 19 39
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  25.0%
5
  26.3%
10
  25.6%
>=65 years
15
  75.0%
14
  73.7%
29
  74.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 19 participants 39 participants
69.76  (7.16) 67.62  (9.77) 68.72  (8.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
Female
12
  60.0%
10
  52.6%
22
  56.4%
Male
8
  40.0%
9
  47.4%
17
  43.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
Asian
2
  10.0%
0
   0.0%
2
   5.1%
White
17
  85.0%
19
 100.0%
36
  92.3%
Other/mixed
1
   5.0%
0
   0.0%
1
   2.6%
1.Primary Outcome
Title Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Rotigotine + Standard Care FAS Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 19
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-1.0  (2.1) -5.3  (2.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.134
Comments [Not Specified]
Method ANCOVA
Comments The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.31
Confidence Interval (2-Sided) 95%
-10.04 to 1.41
Estimation Comments The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).
2.Primary Outcome
Title Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Rotigotine + Standard Care FAS Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Least Squares Mean (Standard Error)
Unit of Measure: Scores on scale
-0.394  (0.160) -0.389  (0.167)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.982
Comments [Not Specified]
Method ANCOVA
Comments The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.44 to 0.45
Estimation Comments The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).
3.Primary Outcome
Title Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Rotigotine + Standard Care FAS Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.495  (0.231) -0.674  (0.238)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.566
Comments [Not Specified]
Method ANCOVA
Comments The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.81 to 0.45
Estimation Comments The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).
4.Primary Outcome
Title Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Rotigotine + Standard Care FAS Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.450  (0.156) -0.525  (0.156)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.720
Comments [Not Specified]
Method ANCOVA
Comments The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.50 to 0.35
Estimation Comments The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).
5.Primary Outcome
Title Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Rotigotine + Standard Care FAS Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.489  (0.141) -0.342  (0.143)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.443
Comments [Not Specified]
Method ANCOVA
Comments The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-0.24 to 0.53
Estimation Comments The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).
6.Primary Outcome
Title Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Rotigotine + Standard Care FAS Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
0.083  (0.242) -0.009  (0.238)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.777
Comments [Not Specified]
Method ANCOVA
Comments The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.75 to 0.57
Estimation Comments The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).
7.Primary Outcome
Title Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Rotigotine + Standard Care FAS Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.178  (0.115) -0.188  (0.117)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.947
Comments [Not Specified]
Method ANCOVA
Comments The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.33 to 0.31
Estimation Comments The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).
8.Primary Outcome
Title Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Rotigotine + Standard Care FAS Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
0.119  (0.190) -0.147  (0.188)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.306
Comments [Not Specified]
Method ANCOVA
Comments The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-0.79 to 0.26
Estimation Comments The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).
9.Primary Outcome
Title Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Rotigotine + Standard Care FAS Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.202  (0.102) -0.171  (0.106)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.819
Comments [Not Specified]
Method ANCOVA
Comments The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.25 to 0.31
Estimation Comments The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).
10.Primary Outcome
Title Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Rotigotine + Standard Care FAS Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.240  (0.123) -0.167  (0.122)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.663
Comments [Not Specified]
Method ANCOVA
Comments The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.26 to 0.41
Estimation Comments [Not Specified]
11.Primary Outcome
Title Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Rotigotine + Standard Care FAS Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
0.125  (0.108) -0.074  (0.112)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.197
Comments [Not Specified]
Method ANCOVA
Comments The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.51 to 0.11
Estimation Comments [Not Specified]
12.Primary Outcome
Title Neupro Dose Per 24h at Visit 2 (Week 12)
Hide Description Daily dose of study medication taken at respective visit.
Time Frame Visit 2 (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Rotigotine + Standard Care FAS Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: mg/24 hr
3.9  (1.7) 4.8  (1.8)
13.Primary Outcome
Title Number of Neupro Dose Changes During the Study
Hide Description Dose adjustments during study are performed per standard of care.
Time Frame Visit 1 (Week 1) to Visit 2 (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) included all subjects who received at least 1 dose of Neupro.
Arm/Group Title Rotigotine + Standard Care SS Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: dose changes
1.8  (1.2) 2.8  (1.7)
14.Primary Outcome
Title Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study
Hide Description Number of subjects who discontinued Neupro Treatment were recorded.
Time Frame Visit 1 (Week 1) to Visit 2 (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) included all subjects who received at least 1 dose of Neupro.
Arm/Group Title Rotigotine + Standard Care SS Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 19
Measure Type: Count of Participants
Unit of Measure: Participants
5
  25.0%
5
  26.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine + Standard Care SS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.876
Comments P-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment and center.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.23 to 5.66
Estimation Comments Odds ratio was calculated as Control Group/Experimental Group (Rotigotine + Standard Care SS / Rotigotine + Standard Care + Kinesia-360™ wearable device SS) calculated using logistic regression with factors for treatment and center.
15.Secondary Outcome
Title Number of Subjects With Any Adverse Events During the Course of the Study
Hide Description 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)
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Hide Analysis Population Description
The Safety Set (SS) included all subjects who received at least 1 dose of Neupro.
Arm/Group Title Rotigotine + Standard Care SS Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 19
Measure Type: Count of Participants
Unit of Measure: Participants
9
  45.0%
11
  57.9%
Time Frame From Visit 1 (Day 1) to Visit 2 (Week 12)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rotigotine + Standard Care Rotigotine + Standard Care + Kinesia-360™ Wearable Device
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Rotigotine + Standard Care Rotigotine + Standard Care + Kinesia-360™ Wearable Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/19 (0.00%)    
Hide Serious Adverse Events
Rotigotine + Standard Care Rotigotine + Standard Care + Kinesia-360™ Wearable Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      1/19 (5.26%)    
Gastrointestinal disorders     
Small intestinal obstruction * 1  0/20 (0.00%)  0 1/19 (5.26%)  1
Metabolism and nutrition disorders     
Dehydration * 1  1/20 (5.00%)  1 0/19 (0.00%)  0
Renal and urinary disorders     
Renal impairment * 1  1/20 (5.00%)  1 0/19 (0.00%)  0
1
Term from vocabulary, MedDRA20.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rotigotine + Standard Care Rotigotine + Standard Care + Kinesia-360™ Wearable Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/20 (45.00%)      10/19 (52.63%)    
Eye disorders     
Vision blurred * 1  0/20 (0.00%)  0 1/19 (5.26%)  1
Gastrointestinal disorders     
Diarrhoea * 1  0/20 (0.00%)  0 1/19 (5.26%)  1
Abdominal distension * 1  1/20 (5.00%)  1 0/19 (0.00%)  0
Constipation * 1  1/20 (5.00%)  1 0/19 (0.00%)  0
Abdominal discomfort * 1  1/20 (5.00%)  1 0/19 (0.00%)  0
Nausea * 1  3/20 (15.00%)  3 2/19 (10.53%)  2
Vomiting * 1  1/20 (5.00%)  1 0/19 (0.00%)  0
General disorders     
Application site pruritus * 1  0/20 (0.00%)  0 1/19 (5.26%)  1
Fatigue * 1  1/20 (5.00%)  1 3/19 (15.79%)  3
Asthenia * 1  0/20 (0.00%)  0 2/19 (10.53%)  2
Feeling abnormal * 1  1/20 (5.00%)  1 0/19 (0.00%)  0
Chest discomfort * 1  0/20 (0.00%)  0 1/19 (5.26%)  1
Investigations     
Weight increased * 1  0/20 (0.00%)  0 1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders     
Muscular weakness * 1  1/20 (5.00%)  1 0/19 (0.00%)  0
Nervous system disorders     
Somnolence * 1  3/20 (15.00%)  3 4/19 (21.05%)  5
Headache * 1  1/20 (5.00%)  1 1/19 (5.26%)  1
Dizziness * 1  1/20 (5.00%)  1 2/19 (10.53%)  2
Psychiatric disorders     
Binge eating * 1  1/20 (5.00%)  1 0/19 (0.00%)  0
Hallucination, visual * 1  1/20 (5.00%)  1 1/19 (5.26%)  1
Hallucination, auditory * 1  1/20 (5.00%)  1 0/19 (0.00%)  0
Sleep disorder * 1  1/20 (5.00%)  1 0/19 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  1/20 (5.00%)  1 1/19 (5.26%)  1
Vascular disorders     
Hot flush * 1  0/20 (0.00%)  0 1/19 (5.26%)  1
1
Term from vocabulary, MedDRA20.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma S.P.R.L. )
ClinicalTrials.gov Identifier: NCT03103919    
Other Study ID Numbers: PD0049
First Submitted: March 30, 2017
First Posted: April 6, 2017
Results First Submitted: January 2, 2019
Results First Posted: February 19, 2019
Last Update Posted: February 19, 2019