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Completed

NCT Number: NCT03103919

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

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.

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Key information

Conditions

Parkinson´s Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pd0049 105, Fountain Valley, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

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.

Other names: Neupro

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

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

    Time frame: Visit 2 (Week 12)

    Daily dose of study medication taken at respective visit.

  13. 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.

  14. 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

  1. Number of Subjects With Any Adverse Events During the Course of the Study

    Time frame: Visit 1 (Week 1) to Visit 2 (Week 12)

    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.

Sponsors and collaborators

Lead sponsor

UCB Biopharma S.P.R.L.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2017
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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