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

UCB

Status and phase: Completed; Phase 4

Conditions: Parkinson´s Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03103919

PD0049

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Rotigotine + Standard Care

Active Comparator group

Description:

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.

Treatment:

Drug: Rotigotine

Device: Kinesia-ONE™

Rotigotine + Standard Care + Kinesia-360™ wearable device

Experimental group

Description:

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.

Treatment:

Drug: Rotigotine

Device: Kinesia-ONE™

Device: Kinesia-360™