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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 8
- Primary Endpoint
- Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Rotigotine + Standard Care
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.
Intervention: Kinesia-ONE™ (Device)
Rotigotine + Standard Care
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.
Intervention: Rotigotine (Drug)
Rotigotine + Standard Care + Kinesia-360™ wearable device
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.
Intervention: Kinesia-ONE™ (Device)
Rotigotine + Standard Care + Kinesia-360™ wearable device
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.
Intervention: Kinesia-360™ (Device)
Rotigotine + Standard Care + Kinesia-360™ wearable device
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.
Intervention: Rotigotine (Drug)
Outcomes
Primary Outcomes
Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score
Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro)
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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score
Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score
Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score
Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score
Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores
Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score
Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score
Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score
Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score
Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
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.
Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score
Time Frame: Baseline (Visit 1/Week 1) to Visit 2 (Week 12)
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.
Neupro Dose Per 24h at Visit 2 (Week 12)
Time Frame: Visit 2 (Week 12)
Daily dose of study medication taken at respective visit.
Number of Neupro Dose Changes During the Study
Time Frame: Visit 1 (Week 1) to Visit 2 (Week 12)
Dose adjustments during study are performed per standard of care.
Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study
Time Frame: Visit 1 (Week 1) to Visit 2 (Week 12)
Number of subjects who discontinued Neupro Treatment were recorded.
Secondary Outcomes
- Number of Subjects With Any Adverse Events During the Course of the Study(Visit 1 (Week 1) to Visit 2 (Week 12))