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

• Status: Completed
• Trial end date: 2018-01-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma S.P.R.L.
• Treatments: N 0437; Rotigotine

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