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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
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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.

Condition or disease Intervention/treatment Phase
Parkinson´s Disease Device: Kinesia-ONE™ Device: Kinesia-360™ Drug: Rotigotine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 16, 2017
Actual Primary Completion Date : January 2, 2018
Actual Study Completion Date : January 2, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rotigotine

Arm Intervention/treatment
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.
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.

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

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.
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103919


Locations
United States, California
Pd0049 105
Fountain Valley, California, United States, 92708
United States, Florida
Pd0049 102
Boca Raton, Florida, United States, 33486
United States, Illinois
Pd0049 108
Winfield, Illinois, United States, 60190
United States, Kansas
Pd0049 103
Kansas City, Kansas, United States, 66160
United States, New York
Pd0049 106
Commack, New York, United States, 11725
United States, Oklahoma
Pd0049 104
Tulsa, Oklahoma, United States, 74136
United States, South Carolina
Pd0049 107
Greenville, South Carolina, United States, 29615
United States, Texas
Pd0049 109
Houston, Texas, United States, 77030
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
Study Director: UCB Cares +1 844 599 2273 (UCB)

Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03103919     History of Changes
Other Study ID Numbers: PD0049
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Parkinson´s Disease
Kinesia-360™
Kinesia-ONE™
Biosensor

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs