Clinical trial NCT03103919: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson´s Disease
Keywords: Parkinson´s Disease
Kinesia-360™
Kinesia-ONE™
Biosensor
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score
timeFrame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro)
measure: Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score
timeFrame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
measure: Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score
timeFrame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
measure: Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores
timeFrame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
measure: Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score
timeFrame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
measure: Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score
timeFrame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
measure: Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score
timeFrame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
measure: Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score
timeFrame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
measure: Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score
timeFrame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
measure: Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score
timeFrame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
measure: Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score
timeFrame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
measure: Neupro Dose Per 24h at Visit 2 (Week 12)
timeFrame: Visit 2 (Week 12)
measure: Number of Neupro Dose Changes During the Study
timeFrame: Visit 1 (Week 1) to Visit 2 (Week 12)
measure: Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study
timeFrame: Visit 1 (Week 1) to Visit 2 (Week 12)
Secondary outcomes:
measure: Number of Subjects With Any Adverse Events During the Course of the Study
timeFrame: Visit 1 (Week 1) to Visit 2 (Week 12)
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Pd0049 105
state: California
city: Boca Raton
country: United States
facility: Pd0049 102
state: Florida
city: Winfield
country: United States
facility: Pd0049 108
state: Illinois
city: Kansas City
country: United States
facility: Pd0049 103
state: Kansas
city: Commack
country: United States
facility: Pd0049 106
state: New York
city: Tulsa
country: United States
facility: Pd0049 104
state: Oklahoma
city: Greenville
country: United States
facility: Pd0049 107
state: South Carolina
city: Houston
country: United States
facility: Pd0049 109
state: Texas
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: