Trial Outcomes & Findings for Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management (NCT NCT03103919)

NCT ID: NCT03103919

Last Updated: 2019-02-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro)
• Results posted on: 2019-02-19

Participant Flow

The study started to enroll patients in March 2017 and concluded in January 2018.

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	20	19
Overall Study COMPLETED	18	17
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	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.	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.
Overall Study Adverse Event	2	2

Baseline Characteristics

Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management

Baseline characteristics by cohort

Measure	Rotigotine + Standard Care n=20 Participants 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device n=19 Participants 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.	Total Title n=39 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Age, Continuous	69.76 years STANDARD_DEVIATION 7.16 • n=5 Participants	67.62 years STANDARD_DEVIATION 9.77 • n=7 Participants	68.72 years STANDARD_DEVIATION 8.49 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Other/mixed	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rotigotine + Standard Care FAS n=20 Participants 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS n=19 Participants 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.
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	-5.3 Scores on a scale Standard Error 2.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rotigotine + Standard Care FAS n=19 Participants 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS n=18 Participants 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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score	-0.394 Scores on scale Standard Error 0.160	-0.389 Scores on scale Standard Error 0.167

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rotigotine + Standard Care FAS n=19 Participants 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS n=18 Participants 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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score	-0.495 Scores on a scale Standard Error 0.231	-0.674 Scores on a scale Standard Error 0.238

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rotigotine + Standard Care FAS n=19 Participants 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS n=18 Participants 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.
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	-0.525 Scores on a scale Standard Error 0.156

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rotigotine + Standard Care FAS n=19 Participants 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS n=18 Participants 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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score	-0.489 Scores on a scale Standard Error 0.141	-0.342 Scores on a scale Standard Error 0.143

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rotigotine + Standard Care FAS n=19 Participants 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS n=18 Participants 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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score	0.083 Scores on a scale Standard Error 0.242	-0.009 Scores on a scale Standard Error 0.238

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rotigotine + Standard Care FAS n=19 Participants 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS n=18 Participants 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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score	-0.178 Scores on a scale Standard Error 0.115	-0.188 Scores on a scale Standard Error 0.117

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rotigotine + Standard Care FAS n=19 Participants 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS n=18 Participants 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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score	0.119 Scores on a scale Standard Error 0.190	-0.147 Scores on a scale Standard Error 0.188

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rotigotine + Standard Care FAS n=19 Participants 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS n=18 Participants 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.
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	-0.171 Scores on a scale Standard Error 0.106

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rotigotine + Standard Care FAS n=19 Participants 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS n=18 Participants 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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score	-0.240 Scores on a scale Standard Error 0.123	-0.167 Scores on a scale Standard Error 0.122

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rotigotine + Standard Care FAS n=19 Participants 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS n=18 Participants 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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score	0.125 Scores on a scale Standard Error 0.108	-0.074 Scores on a scale Standard Error 0.112

PRIMARY outcome

Timeframe: 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.

Daily dose of study medication taken at respective visit.

Outcome measures

Measure	Rotigotine + Standard Care FAS n=16 Participants 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS n=16 Participants 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.
Neupro Dose Per 24h at Visit 2 (Week 12)	3.9 mg/24 hr Standard Deviation 1.7	4.8 mg/24 hr Standard Deviation 1.8

PRIMARY outcome

Timeframe: 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.

Dose adjustments during study are performed per standard of care.

Outcome measures

Measure	Rotigotine + Standard Care FAS n=20 Participants 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS n=19 Participants 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.
Number of Neupro Dose Changes During the Study	1.8 dose changes Standard Deviation 1.2	2.8 dose changes Standard Deviation 1.7

PRIMARY outcome

Timeframe: 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.

Number of subjects who discontinued Neupro Treatment were recorded.

Outcome measures

Measure	Rotigotine + Standard Care FAS n=20 Participants 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS n=19 Participants 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.
Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study	5 Participants	5 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Rotigotine + Standard Care FAS n=20 Participants 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS n=19 Participants 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.
Number of Subjects With Any Adverse Events During the Course of the Study	9 Participants	11 Participants

Adverse Events

Rotigotine + Standard Care

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Rotigotine + Standard Care + Kinesia-360™ Wearable Device

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rotigotine + Standard Care n=20 participants at risk 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device n=19 participants at risk 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.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/20 • From Visit 1 (Day 1) to Visit 2 (Week 12)	5.3% 1/19 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Metabolism and nutrition disorders Dehydration	5.0% 1/20 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)	0.00% 0/19 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Renal and urinary disorders Renal impairment	5.0% 1/20 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)	0.00% 0/19 • From Visit 1 (Day 1) to Visit 2 (Week 12)

Other adverse events

Measure	Rotigotine + Standard Care n=20 participants at risk 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.	Rotigotine + Standard Care + Kinesia-360™ Wearable Device n=19 participants at risk 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.
Eye disorders Vision blurred	0.00% 0/20 • From Visit 1 (Day 1) to Visit 2 (Week 12)	5.3% 1/19 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Gastrointestinal disorders Diarrhoea	0.00% 0/20 • From Visit 1 (Day 1) to Visit 2 (Week 12)	5.3% 1/19 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Gastrointestinal disorders Abdominal distension	5.0% 1/20 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)	0.00% 0/19 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Gastrointestinal disorders Constipation	5.0% 1/20 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)	0.00% 0/19 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Gastrointestinal disorders Abdominal discomfort	5.0% 1/20 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)	0.00% 0/19 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Gastrointestinal disorders Nausea	15.0% 3/20 • Number of events 3 • From Visit 1 (Day 1) to Visit 2 (Week 12)	10.5% 2/19 • Number of events 2 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Gastrointestinal disorders Vomiting	5.0% 1/20 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)	0.00% 0/19 • From Visit 1 (Day 1) to Visit 2 (Week 12)
General disorders Application site pruritus	0.00% 0/20 • From Visit 1 (Day 1) to Visit 2 (Week 12)	5.3% 1/19 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)
General disorders Fatigue	5.0% 1/20 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)	15.8% 3/19 • Number of events 3 • From Visit 1 (Day 1) to Visit 2 (Week 12)
General disorders Asthenia	0.00% 0/20 • From Visit 1 (Day 1) to Visit 2 (Week 12)	10.5% 2/19 • Number of events 2 • From Visit 1 (Day 1) to Visit 2 (Week 12)
General disorders Feeling abnormal	5.0% 1/20 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)	0.00% 0/19 • From Visit 1 (Day 1) to Visit 2 (Week 12)
General disorders Chest discomfort	0.00% 0/20 • From Visit 1 (Day 1) to Visit 2 (Week 12)	5.3% 1/19 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Investigations Weight increased	0.00% 0/20 • From Visit 1 (Day 1) to Visit 2 (Week 12)	5.3% 1/19 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Musculoskeletal and connective tissue disorders Muscular weakness	5.0% 1/20 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)	0.00% 0/19 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Nervous system disorders Somnolence	15.0% 3/20 • Number of events 3 • From Visit 1 (Day 1) to Visit 2 (Week 12)	21.1% 4/19 • Number of events 5 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)	5.3% 1/19 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Nervous system disorders Dizziness	5.0% 1/20 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)	10.5% 2/19 • Number of events 2 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Psychiatric disorders Binge eating	5.0% 1/20 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)	0.00% 0/19 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Psychiatric disorders Hallucination, visual	5.0% 1/20 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)	5.3% 1/19 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Psychiatric disorders Hallucination, auditory	5.0% 1/20 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)	0.00% 0/19 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Psychiatric disorders Sleep disorder	5.0% 1/20 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)	0.00% 0/19 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.0% 1/20 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)	5.3% 1/19 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)
Vascular disorders Hot flush	0.00% 0/20 • From Visit 1 (Day 1) to Visit 2 (Week 12)	5.3% 1/19 • Number of events 1 • From Visit 1 (Day 1) to Visit 2 (Week 12)

Additional Information

UCB

Cares

Phone: +1844 599

Email: UCBCares@ucb.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60