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

Parkinson´s Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103919
• Other study ID #: PD0049
• Status: Completed
• Phase: Phase 4
• Start date: March 16, 2017
• Est. completion date: January 2, 2018

Study information

• Verified date: February 2019
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2, 2018
• Est. primary completion date: January 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson´s Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Pd0049 102	Boca Raton	Florida
United States	Pd0049 106	Commack	New York
United States	Pd0049 105	Fountain Valley	California
United States	Pd0049 107	Greenville	South Carolina
United States	Pd0049 109	Houston	Texas
United States	Pd0049 103	Kansas City	Kansas
United States	Pd0049 104	Tulsa	Oklahoma
United States	Pd0049 108	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score	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.	Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro)
Primary	Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score	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.	Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Primary	Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score	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.	Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Primary	Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores	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.	Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Primary	Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score	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.	Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Primary	Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score	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.	Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Primary	Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score	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.	Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Primary	Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score	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.	Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Primary	Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score	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.	Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Primary	Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score	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.	Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Primary	Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score	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.	Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
Primary	Neupro Dose Per 24h at Visit 2 (Week 12)	Daily dose of study medication taken at respective visit.	Visit 2 (Week 12)
Primary	Number of Neupro Dose Changes During the Study	Dose adjustments during study are performed per standard of care.	Visit 1 (Week 1) to Visit 2 (Week 12)
Primary	Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study	Number of subjects who discontinued Neupro Treatment were recorded.	Visit 1 (Week 1) to Visit 2 (Week 12)
Secondary	Number of Subjects With Any Adverse Events During the Course of the Study	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.	Visit 1 (Week 1) to Visit 2 (Week 12)

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