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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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. )

Tracking Information
First Submitted Date  ICMJE March 30, 2017
First Posted Date  ICMJE April 6, 2017
Results First Submitted Date  ICMJE January 2, 2019
Results First Posted Date  ICMJE February 19, 2019
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE March 16, 2017
Actual Primary Completion Date January 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2019)
  • Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro) ]
    UPDRS Part III has 27 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Each of the 27 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The motor score ranges from 0 to 108, where the maximum score indicates the worse condition. A negative value in change in Unified Parkinson's Disease Rating Scale indicates improvement, whereas a positive value indicates worsening of disease.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. The finger tapping speed scores and resting tremor scores were averaged and provided as one score ranging from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
  • Neupro Dose Per 24h at Visit 2 (Week 12) [ Time Frame: Visit 2 (Week 12) ]
    Daily dose of study medication taken at respective visit.
  • Number of Neupro Dose Changes During the Study [ Time Frame: Visit 1 (Week 1) to Visit 2 (Week 12) ]
    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 [ Time Frame: Visit 1 (Week 1) to Visit 2 (Week 12) ]
    Number of subjects who discontinued Neupro Treatment were recorded.
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
  • Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro) ]
    UPDRS Part III has 27 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Each of the 27 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The motor score ranges from 0 to 108.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures will be averaged from triplicate repeated assessments at a measurement point.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures will be averaged from triplicate repeated assessments at a measurement point.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures will be averaged from triplicate repeated assessments at a measurement point. The finger tapping speed scores and resting tremor scores will be averaged and provided as one score ranging from 0-4.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures will be averaged from triplicate repeated assessments at a measurement point.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures will be averaged from triplicate repeated assessments at a measurement point.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures will be averaged from triplicate repeated assessments at a measurement point.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures will be averaged from triplicate repeated assessments at a measurement point.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures will be averaged from triplicate repeated assessments at a measurement point.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures will be averaged from triplicate repeated assessments at a measurement point.
  • Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score [ Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12) ]
    Kinesia-ONE™ measures will be averaged from triplicate repeated assessments at a measurement point.
  • Mean Neupro dose per 24h at Visit 2 (Week 12) [ Time Frame: Visit 2 (Week 12) ]
    Daily dose of study medication taken at respective visit.
  • Number of Neupro Dose Changes During the Study [ Time Frame: Visit 1 (Week 1) to Visit 2 (Week 12) ]
    Dose adjustments during study are performed per standard of care.
  • Discontinuation of treatment with Neupro during the course of the study [ Time Frame: Visit 1 (Week 1) to Visit 2 (Week 12) ]
    Number of subjects discontinuing from Neupro Treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2019)
Number of Subjects With Any Adverse Events During the Course of the Study [ Time Frame: Visit 1 (Week 1) to Visit 2 (Week 12) ]
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
Occurences of Adverse Events during the course of the study [ Time Frame: Visit 1 (Week 1) to Visit 2 (Week 12) ]
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson´s Disease
Intervention  ICMJE
  • Device: Kinesia-ONE™
    Kinesia-ONE™ wearable sensor uses a subject-worn finger sensor and iPad mini application (APP) to objectively measure specific motor tasks related to Parkinson's disease symptoms such as tremor, bradykinesia (slowed movements), and dyskinesia (involuntary movements) in the Investigator's office. Subjects should wear the Kinesia-ONE™ device on the most affected side.
  • Device: Kinesia-360™
    Kinesia-360™ wearable sensor includes a wrist and ankle device, along with a cell phone, which is also APP-based, and is designed for continuous day time monitoring of Parkinson's disease symptoms. Subjects will wear Kinesia-360™ while they go about their daily lives, and symptom severity is continually captured to enable objective assessment of Parkinson's disease symptoms. Subjects should wear the Kinesia-360™ device bands on the most affected side.
  • Drug: Rotigotine
    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.
    Other Name: Neupro
Study Arms  ICMJE
  • Active Comparator: Rotigotine + Standard Care
    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.
    Interventions:
    • Device: Kinesia-ONE™
    • Drug: Rotigotine
  • Experimental: Rotigotine + Standard Care + Kinesia-360™ wearable device
    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.
    Interventions:
    • Device: Kinesia-ONE™
    • Device: Kinesia-360™
    • Drug: Rotigotine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2, 2018
Actual Primary Completion Date January 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03103919
Other Study ID Numbers  ICMJE PD0049
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB Biopharma S.P.R.L. )
Study Sponsor  ICMJE UCB Biopharma S.P.R.L.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares +1 844 599 2273 (UCB)
PRS Account UCB Pharma
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP