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

NCT03103919 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: PD0049
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

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.

Conditions

Parkinson´s Disease

Keywords

Parkinson´s Disease; Kinesia-360™; Kinesia-ONE™; Biosensor

Outcome Measures

Primary Outcomes (14)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• Neupro Dose Per 24h at Visit 2 (Week 12)

  Daily dose of study medication taken at respective visit.

  Visit 2 (Week 12)

• 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)

• 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 Outcomes (1)

• Number of Subjects With Any Adverse Events During the Course of the Study

  Visit 1 (Week 1) to Visit 2 (Week 12)

Study Arms (2)

Rotigotine + Standard Care

ACTIVE COMPARATOR

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™; Drug: Rotigotine

Rotigotine + Standard Care + Kinesia-360™ wearable device

EXPERIMENTAL

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™; Device: Kinesia-360™; Drug: Rotigotine

Interventions

Kinesia-ONE™ DEVICE

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.

Rotigotine + Standard Care; Rotigotine + Standard Care + Kinesia-360™ wearable device

Kinesia-360™ DEVICE

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.

Rotigotine + Standard Care + Kinesia-360™ wearable device

Rotigotine DRUG

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.

Also known as: Neupro

Rotigotine + Standard Care; Rotigotine + Standard Care + Kinesia-360™ wearable device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead

Study Sites (8)

Pd0049 105

Fountain Valley, California, 92708, United States

Location

Pd0049 102

Boca Raton, Florida, 33486, United States

Location

Pd0049 108

Winfield, Illinois, 60190, United States

Location

Pd0049 103

Kansas City, Kansas, 66160, United States

Location

Pd0049 106

Commack, New York, 11725, United States

Location

Pd0049 104

Tulsa, Oklahoma, 74136, United States

Location

Pd0049 107

Greenville, South Carolina, 29615, United States

Location

Pd0049 109

Houston, Texas, 77030, United States

Location

Related Links

• Product Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Parkinson Disease

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1844 599

Study Officials

• UCB Cares

  +1 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 6, 2017
• Study Start: March 16, 2017
• Primary Completion: January 2, 2018
• Study Completion: January 2, 2018
• Last Updated: February 19, 2019
• Results First Posted: February 19, 2019

Record last verified: 2019-02

Locations

US (8)