Utilization of Target Ranges to Treat Persons With Parkinson's Disease by Objective Measurement Using the PKG

NCT04381065 | Withdrawn FDA Device

• 1 other identifier: Study 004
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of this study is to evaluate whether persons with Parkinson's disease (PwP) whose Parkinson's disease (PD) symptoms are uncontrolled have improved clinical patient outcomes and quality of life when managed with the aid of objective measurement and use of PKG target ranges compared to PwP treated using only standard of care (SOC) (medical history, physical examination).

Conditions

Parkinson Disease

Keywords

Personal KinetiGraph® (PKG®) System; Objective Measurement

Outcome Measures

Primary Outcomes (1)

• Change in Patient Outcomes using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  The change in MDS-UPDRS Total score at 4 months from baseline defined as sections I, II, III (per core lab measurement) and IV in PwP. The endpoint will be compared between subjects out of target at baseline for those who are treated with SOC and PKG data (PKG+ Group) versus those who are treated per SOC alone (PKG- Group).

  4 months

Secondary Outcomes (12)

• Responder rate for total MDS-UPDRS

  4 months

• Responder rate for PKG

  4 months

• Change in MDS-UPDRS motor endpoints

  4 months, 1 year, 2 years, 3 years

• Change in MDS-UPDRS total

  1 year, 2 years, 3 years

• Change in MDS-UPDRS sub parts

  4 months, 1 year, 2 years, 3 years

Other Outcomes (7)

• Levodopa Equivalent Dose (LED)

  4 months, 1 year, 2 years, 3 years

• PKG Patient Survey

  4 months, 1 year, 2 years, 3 years

• Healthcare Utilization

  4 months, 1 year, 2 years, 3 years

Study Arms (2)

PKG+ Group

EXPERIMENTAL

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 in the target range or out of the target range based on scores provided by the PKG.

Device: Personal KinetiGraph® (PKG®) System

PKG- Group

PLACEBO COMPARATOR

For subjects in the PKG- 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.

Device: Personal KinetiGraph® (PKG®) Watch

Interventions

Personal KinetiGraph® (PKG®) System DEVICE

The Personal KinetiGraph (PKG®) System consists of the following: * A wrist-worn movement recording device known as the PKG® Watch, designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period * Proprietary algorithms to translate raw movement data collected by the PKG® Watch * Data-driven report known as the PKG® The PKG® provides continuous, objective, ambulatory assessment of the treatable and disabling symptoms of Parkinson's disease including tremor, bradykinesia and dyskinesia. The PKG® also provides an assessment of daytime somnolence and an indication of propensity for impulsive behaviors.

PKG+ Group

Personal KinetiGraph® (PKG®) Watch DEVICE

The Personal KinetiGraph (PKG®) System consists of the following: * A wrist-worn movement recording device known as the PKG® Watch, designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period * Proprietary algorithms to translate raw movement data collected by the PKG® Watch

PKG- Group

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to sign a written informed consent for study participation and comply with all required follow-up visits
• Presumed to have levodopa responsive PD
• Taking levodopa for at least 30 days prior to screening visit
• Planning to continue using levodopa for PD throughout study participation
• Able to increase levodopa by a minimum of 100mg/day
• Age inclusive at the time of consent of 55-80 years
• Has not received a PKG in the last 12 months

You may not qualify if:

• Evidence of atypical or secondary parkinsonism
• Presence of any non-parkinsonian tremors
• Contraindication to increasing levodopa
• Requires the addition of or dose adjustment of an anti-dyskinesia medication within the next 4 months
• Those who have received advanced therapies including individuals no longer actively utilizing these therapies, or planning to receive advanced therapies in the next 6 months
• MoCA score \<23 at screening visit
• Bedridden, wheelchair confined, or requires the regular use of an assistive gait device
• Predominant sleep period is during the daytime hours of 9am to 6pm (e.g. third shift worker)
• 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

Sponsors & Collaborators

• Global Kinetics Corporation: lead

Related Publications (2)

• Pahwa R, Isaacson SH, Torres-Russotto D, Nahab FB, Lynch PM, Kotschet KE. Role of the Personal KinetiGraph in the routine clinical assessment of Parkinson's disease: recommendations from an expert panel. Expert Rev Neurother. 2018 Aug;18(8):669-680. doi: 10.1080/14737175.2018.1503948. Epub 2018 Jul 26.

  PMID: 30032695 BACKGROUND

• Shulman LM, Gruber-Baldini AL, Anderson KE, Fishman PS, Reich SG, Weiner WJ. The clinically important difference on the unified Parkinson's disease rating scale. Arch Neurol. 2010 Jan;67(1):64-70. doi: 10.1001/archneurol.2009.295.

  PMID: 20065131 BACKGROUND

Related Links

• Sponsor website

MeSH Terms

Conditions

Parkinson Disease

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Raja Mehanna, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will remain blinded to treatment group throughout the life of the trial. Investigator and research staff will be unblinded to the treatment group as they will or will not have access to the PKG data to be incorporated into their standard of care practice.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible subjects will be randomized using the Electronic Data Capture (EDC) system in a 1:1 ratio to the PKG- Group (standard of care clinical assessments without use of PKG data) or the PKG+ Group (standard of care clinical assessments plus use of PKG data).

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 8, 2020
• Study Start: June 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2026
• Last Updated: February 1, 2021

Record last verified: 2021-01