Utilization of Target Ranges to Treat Parkinson's Disease With the PKG (TARGET-PD)

Global Kinetics

Status: Terminated

Conditions: Parkinson Disease

Treatments: Device: Personal KinetiGraph® (PKG®) Watch; Device: Personal KinetiGraph® (PKG®) Report

Study type: Interventional

Funder types: Industry

Identifiers

NCT03984305

Study 003

Details and patient eligibility

About

The main objective of this study is to evaluate whether people whose PD symptoms are uncontrolled who are managed with the aid of objective measurement and use of target ranges have improved PD symptoms and outcomes as compared to individuals treated using only standard of care (medical history, neurological examination).

Full description

This is a randomized controlled trial (RCT) to evaluate treating uncontrolled patients with Parkinson's Disease (PwP) to a target range as suggested by expert review papers. The study aims to evaluate clinical patient outcomes, quality of life measures and health care utilization of those patients specifically treated to a target range when using the PKG data in the clinical management of Parkinson's disease (PD) in routine clinical care (treatment group) compared to those managed with medical history and clinical evaluation alone (control group) performed by a neurologist experienced in PD management. Both groups will be recommended to undergo medication changes until they reach a "controlled state" that is determined by either the clinician using standard of care (SOC) (PKG- Group) or using PKG based targets and SOC assessments (PKG+ Group).

Enrollment: 41 patients

Sex: All

Ages: 46 to 83 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able and willing to sign a written informed consent for study participation
• Presumed to have Levodopa responsive idiopathic Parkinson's Disease
• Age inclusive at the time of consent per PKG Indications for Use (46-83 years old)
• Has not been previously managed with the PKG

Exclusion criteria

• Contraindication to increasing levodopa (e.g. orthostatic hypotension, hallucinations/psychosis or any other medical condition in the last year that would preclude increasing levodopa or other appropriate Parkinson's Disease medications)
• MoCA score <23 at screening visit
• Diagnosis of Essential Tremor
• Wheelchair bound or bedridden
• Currently utilizing or planning in the next 6 months advanced PD therapies (DBS, infusion, etc.)
• In the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to comply with study requirements or interfere with interpretation of the study endpoints (e.g., subject unable to complete PKG watch wear instructions per Patient Instruction Manual)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 2 patient groups, including a placebo group

PKG+ Group

Experimental group

Description:

For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG.

Treatment:

Device: Personal KinetiGraph® (PKG®) Report

Device: Personal KinetiGraph® (PKG®) Watch

PKG- Group

Placebo Comparator group

Description:

For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans.

Treatment:

Device: Personal KinetiGraph® (PKG®) Watch