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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

Primary Purpose

Parkinson´s Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Kinesia-ONE™
Kinesia-360™
Rotigotine
Sponsored by
UCB Biopharma S.P.R.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson´s Disease focused on measuring Parkinson´s Disease, Kinesia-360™, Kinesia-ONE™, Biosensor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pd0049 105
  • Pd0049 102
  • Pd0049 108
  • Pd0049 103
  • Pd0049 106
  • Pd0049 104
  • Pd0049 107
  • Pd0049 109

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Rotigotine + Standard Care

Rotigotine + Standard Care + Kinesia-360™ wearable device

Arm Description

Subjects will use 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 will be determined by standard clinical practice.

Subjects will use the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects will use the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator will use 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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Neupro Dose Per 24h at Visit 2 (Week 12)
Daily dose of study medication taken at respective visit.
Number of Neupro Dose Changes During the Study
Dose adjustments during study are performed per standard of care.
Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study
Number of subjects who discontinued Neupro Treatment were recorded.

Secondary Outcome Measures

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.

Full Information

First Posted
March 30, 2017
Last Updated
February 16, 2019
Sponsor
UCB Biopharma S.P.R.L.
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1. Study Identification

Unique Protocol Identification Number
NCT03103919
Brief Title
Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management
Official Title
A Multicenter, Open-Label, Two-Arm Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 16, 2017 (Actual)
Primary Completion Date
January 2, 2018 (Actual)
Study Completion Date
January 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma S.P.R.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson´s Disease
Keywords
Parkinson´s Disease, Kinesia-360™, Kinesia-ONE™, Biosensor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotigotine + Standard Care
Arm Type
Active Comparator
Arm Description
Subjects will use 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 will be determined by standard clinical practice.
Arm Title
Rotigotine + Standard Care + Kinesia-360™ wearable device
Arm Type
Experimental
Arm Description
Subjects will use the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects will use the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator will use 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.
Intervention Type
Device
Intervention Name(s)
Kinesia-ONE™
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Kinesia-360™
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Rotigotine
Other Intervention Name(s)
Neupro
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score
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)
Title
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score
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)
Title
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score
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)
Title
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores
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)
Title
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score
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)
Title
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score
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)
Title
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score
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)
Title
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score
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)
Title
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score
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)
Title
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score
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)
Title
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score
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)
Title
Neupro Dose Per 24h at Visit 2 (Week 12)
Description
Daily dose of study medication taken at respective visit.
Time Frame
Visit 2 (Week 12)
Title
Number of Neupro Dose Changes During the Study
Description
Dose adjustments during study are performed per standard of care.
Time Frame
Visit 1 (Week 1) to Visit 2 (Week 12)
Title
Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study
Description
Number of subjects who discontinued Neupro Treatment were recorded.
Time Frame
Visit 1 (Week 1) to Visit 2 (Week 12)
Secondary Outcome Measure Information:
Title
Number of Subjects With Any Adverse Events During the Course of the Study
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Pd0049 105
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Pd0049 102
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Pd0049 108
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Pd0049 103
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Pd0049 106
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Pd0049 104
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Pd0049 107
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Pd0049 109
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.neupro.com/neupro-prescribing-information.pdf?v=1489766618
Description
Product Information
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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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