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



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:2/21/2019
Start Date:March 16, 2017
End Date:January 2, 2018

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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

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.


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
We found this trial at
8
sites
Kansas City, Kansas 66160
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Boca Raton, Florida 33486
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Boca Raton, FL
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Commack, New York 11725
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Commack, NY
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Fountain Valley, California 92708
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Fountain Valley, CA
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Greenville, South Carolina 29615
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Greenville, SC
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Houston, Texas 77030
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Houston, TX
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Tulsa, Oklahoma 74136
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Tulsa, OK
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Winfield, Illinois 60190
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Winfield, IL
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