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Utilization of Target Ranges to Treat Persons With Parkinson's Disease by Objective Measurement Using the PKG (TARGET-PwP)

Primary Purpose

Parkinson Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Personal KinetiGraph® (PKG®) System
Personal KinetiGraph® (PKG®) Watch
Sponsored by
Global Kinetics Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson Disease focused on measuring Personal KinetiGraph® (PKG®) System, Objective Measurement

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    PKG+ Group

    PKG- Group

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

    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.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Responder rate for total MDS-UPDRS
    Percent "responders" for total MDS-UPDRS based on a minimal clinically important change of >4 points (Shulman LM, Gruber-Baldini AL, Anderson KE, et al. The Clinically Important Difference on the Unified Parkinson's Disease Rating Scale. Arch Neurol 2010: 67(1):64-70.). The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
    Responder rate for PKG
    Percent "responders" by PKG (defined as BKS change of >2 point improvement)
    Change in MDS-UPDRS motor endpoints
    Change in MDS-UPDRS Part III (per core lab measurement). The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Part III is the motor examination and contains 33 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
    Change in MDS-UPDRS total
    Change in MDS-UPDRS Total score from baseline. The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
    Change in MDS-UPDRS sub parts
    Change in the non-motor (parts I and II) score and change in Part IV for the MDS-UPDRS from baseline. The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
    Change in PKG Bradykinesia Score (BKS)
    Change in the PKG reported BKS from baseline. A higher score represents more severe bradykinesia.
    Change in PKG Dyskinesia score (DKS)
    Change in the PKG reported DKS from baseline. A higher score represents more severe dyskinesia.
    Change in Percent Time in Tremor (PTT)
    Change in the PKG reported PTT from baseline, max 100%. A PTT of >1% indicates that tremor is present.
    Change in Fluctuation Dyskinesia score (FDS)
    Change in the PKG reported FDS from baseline. The higher the score, the more severe the fluctuation, and a FDS of 7.5-13 indicates controlled fluctuations.
    Change in Percent Time Immobile (PTI)
    Change in the PKG reported PTI from baseline, max 100%. A PTI of >5% is considered high.
    Change in Parkinson's Disease Questionnaire-39 questions (PDQ-39)
    Change in the patient reported quality of life questionnaire PDQ-39 from baseline. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality of life issues across 8 dimensions. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.
    Number of Interim Visits
    Number of interim visits conducted from baseline to 4 months in each arm

    Full Information

    First Posted
    May 1, 2020
    Last Updated
    January 27, 2021
    Sponsor
    Global Kinetics Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04381065
    Brief Title
    Utilization of Target Ranges to Treat Persons With Parkinson's Disease by Objective Measurement Using the PKG
    Acronym
    TARGET-PwP
    Official Title
    Utilization of Target Ranges to Treat Persons With Parkinson's Disease by Objective Measurement Using the Personal KinetiGraph® (PKG®) Compared to Standard of Care Assessment (TARGET-PwP)- A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Business decision
    Study Start Date
    June 2020 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    April 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Global Kinetics Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).
    Detailed Description
    This is a randomized controlled trial (RCT) to compare the value of the Personal KinetiGraph® (PKG®) System and SOC vs. the SOC alone for treatment of PwP. The study aims to evaluate clinical outcomes, quality of life outcomes, health economic benefits, duration of controlled status, and need for additional PD treatment through 3 years follow-up of PwP specifically treated to a target range when using the PKG data in the clinical management of PD in routine clinical care compared to those managed with SOC alone. All subjects will be treated by Movement Disorder Specialists and General Neurologists with expertise in PD. Both groups will be recommended to undergo treatment changes until they reach a "controlled state" that is determined by either the clinician using SOC (PKG- Group) or using recommended target ranges for PKG scores and SOC assessments (PKG+ Group). Investigators will utilize standard available treatments to manage these PwP in both groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    Personal KinetiGraph® (PKG®) System, Objective Measurement

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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).
    Masking
    Participant
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PKG+ Group
    Arm Type
    Experimental
    Arm 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 in the target range or out of the target range based on scores provided by the PKG.
    Arm Title
    PKG- Group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Personal KinetiGraph® (PKG®) System
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Personal KinetiGraph® (PKG®) Watch
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change in Patient Outcomes using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
    Description
    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).
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    Responder rate for total MDS-UPDRS
    Description
    Percent "responders" for total MDS-UPDRS based on a minimal clinically important change of >4 points (Shulman LM, Gruber-Baldini AL, Anderson KE, et al. The Clinically Important Difference on the Unified Parkinson's Disease Rating Scale. Arch Neurol 2010: 67(1):64-70.). The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
    Time Frame
    4 months
    Title
    Responder rate for PKG
    Description
    Percent "responders" by PKG (defined as BKS change of >2 point improvement)
    Time Frame
    4 months
    Title
    Change in MDS-UPDRS motor endpoints
    Description
    Change in MDS-UPDRS Part III (per core lab measurement). The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Part III is the motor examination and contains 33 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
    Time Frame
    4 months, 1 year, 2 years, 3 years
    Title
    Change in MDS-UPDRS total
    Description
    Change in MDS-UPDRS Total score from baseline. The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
    Time Frame
    1 year, 2 years, 3 years
    Title
    Change in MDS-UPDRS sub parts
    Description
    Change in the non-motor (parts I and II) score and change in Part IV for the MDS-UPDRS from baseline. The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
    Time Frame
    4 months, 1 year, 2 years, 3 years
    Title
    Change in PKG Bradykinesia Score (BKS)
    Description
    Change in the PKG reported BKS from baseline. A higher score represents more severe bradykinesia.
    Time Frame
    4 months, 1 year, 2 years, 3 years
    Title
    Change in PKG Dyskinesia score (DKS)
    Description
    Change in the PKG reported DKS from baseline. A higher score represents more severe dyskinesia.
    Time Frame
    4 months, 1 year, 2 years, 3 years
    Title
    Change in Percent Time in Tremor (PTT)
    Description
    Change in the PKG reported PTT from baseline, max 100%. A PTT of >1% indicates that tremor is present.
    Time Frame
    4 months, 1 year, 2 years, 3 years
    Title
    Change in Fluctuation Dyskinesia score (FDS)
    Description
    Change in the PKG reported FDS from baseline. The higher the score, the more severe the fluctuation, and a FDS of 7.5-13 indicates controlled fluctuations.
    Time Frame
    4 months, 1 year, 2 years, 3 years
    Title
    Change in Percent Time Immobile (PTI)
    Description
    Change in the PKG reported PTI from baseline, max 100%. A PTI of >5% is considered high.
    Time Frame
    4 months, 1 year, 2 years, 3 years
    Title
    Change in Parkinson's Disease Questionnaire-39 questions (PDQ-39)
    Description
    Change in the patient reported quality of life questionnaire PDQ-39 from baseline. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality of life issues across 8 dimensions. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.
    Time Frame
    4 months, 1 year, 2 years, 3 years
    Title
    Number of Interim Visits
    Description
    Number of interim visits conducted from baseline to 4 months in each arm
    Time Frame
    4 months
    Other Pre-specified Outcome Measures:
    Title
    Levodopa Equivalent Dose (LED)
    Description
    Levodopa Equivalent Dose (LED) at each visit
    Time Frame
    4 months, 1 year, 2 years, 3 years
    Title
    PKG Patient Survey
    Description
    Analyze PKG usability with the PKG Patient reported survey. Questions are on a scale of strongly agree to strongly disagree and will be patient reported information related to their use of the PKG watch. Both treatment groups will be administered the survey and scores will be aggregated by group and compared.
    Time Frame
    4 months, 1 year, 2 years, 3 years
    Title
    Healthcare Utilization
    Description
    Rate of protocol defined adverse events affecting health care utilization from baseline
    Time Frame
    4 months, 1 year, 2 years, 3 years
    Title
    Potential Contraindications
    Description
    Rate of protocol defined adverse events and potential contraindications for increasing dopaminergic therapy from baseline
    Time Frame
    4 months, 1 year, 2 years, 3 years
    Title
    Lifestyle Factors Impacted by PD
    Description
    Rate of protocol defined lifestyle factors impacted by PD
    Time Frame
    4 months, 1 year, 2 years, 3 years
    Title
    Work Productivity and Activity Impairment
    Description
    Change in Work Productivity and Activity Impairment Questionnaire (WPAI) from baseline. The WPAI Questionnaire includes questions regarding impacts to work productivity due to PD symptoms.
    Time Frame
    4 months, 1 year, 2 years, 3 years
    Title
    PKG scores
    Description
    Proportion of enrolled subjects in PKG+ group who are either unable to be brought into the target range or unable to be brought to a BKS ≤26. A higher score represents more severe bradykinesia.
    Time Frame
    4 months, 1 year, 2 years, 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Raja Mehanna, MD
    Organizational Affiliation
    The University of Texas Health Science Center, Houston
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30032695
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20065131
    Citation
    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.
    Results Reference
    background
    Links:
    URL
    https://www.globalkineticscorporation.com/
    Description
    Sponsor website

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

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