Parkinson DiseaseTARGET-PwPNCT04381065
Utilization of Target Ranges to Treat Persons With Parkinson's Disease by Objective Measurement Using the PKG
A study testing Personal KinetiGraph® (PKG®) System and Personal KinetiGraph® (PKG®) Watch in people with Parkinson Disease, run by Global Kinetics Corporation.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Personal KinetiGraph® (PKG®) System and Personal KinetiGraph® (PKG®) Watch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
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
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).
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Personal KinetiGraph® (PKG®) System, Personal KinetiGraph® (PKG®) Watch
- Keywords
- Personal KinetiGraph® (PKG®) System, Objective Measurement
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal KinetiGraph® (PKG®) SystemDevice
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.
Personal KinetiGraph® (PKG®) WatchDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Personal KinetiGraph® (PKG®) Watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 months
Secondary outcomes (12)
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).
Measured: 4 months
Responder rate for PKG
Percent "responders" by PKG (defined as BKS change of >2 point improvement)
Measured: 4 months
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).
Measured: 4 months, 1 year, 2 years, 3 years
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).
Measured: 1 year, 2 years, 3 years
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).
Measured: 4 months, 1 year, 2 years, 3 years
Change in PKG Bradykinesia Score (BKS)
Change in the PKG reported BKS from baseline. A higher score represents more severe bradykinesia.
Measured: 4 months, 1 year, 2 years, 3 years
Change in PKG Dyskinesia score (DKS)
Change in the PKG reported DKS from baseline. A higher score represents more severe dyskinesia.
Measured: 4 months, 1 year, 2 years, 3 years
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.
Measured: 4 months, 1 year, 2 years, 3 years
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.
Measured: 4 months, 1 year, 2 years, 3 years
Change in Percent Time Immobile (PTI)
Change in the PKG reported PTI from baseline, max 100%. A PTI of >5% is considered high.
Measured: 4 months, 1 year, 2 years, 3 years
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.
Measured: 4 months, 1 year, 2 years, 3 years
Number of Interim Visits
Number of interim visits conducted from baseline to 4 months in each arm
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study startJun 2020 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2026 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Kinetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raja Mehanna, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381065
- Sponsor's protocol ID
- Study 004
- Acronym
- TARGET-PwP
- Status last verified
- Jan 2021
- First submitted
- 1 May 2020
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 30032695Shulman 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.
PubMed 20065131
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04381065
- Acronym / sponsor ID
- TARGET-PwP / Study 004
- Conditions
- Parkinson Disease
- Keywords
- Personal KinetiGraph® (PKG®) System, Objective Measurement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Global Kinetics CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2020 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| PKG+ Group | Experimental | Device: Personal KinetiGraph® (PKG®) SystemFor 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. |
| PKG- Group | Placebo comparator | Device: Personal KinetiGraph® (PKG®) WatchFor 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal KinetiGraph® (PKG®) SystemThe 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. | Device | PKG+ Group |
| Personal KinetiGraph® (PKG®) WatchThe 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 | Device | PKG- Group |
Primary outcome
Change in Patient Outcomes using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: 4 months
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).
12 secondary outcomes
Responder rate for total MDS-UPDRS
Time frame: 4 months
Responder rate for PKG
Time frame: 4 months
Change in MDS-UPDRS motor endpoints
Time frame: 4 months, 1 year, 2 years, 3 years
Change in MDS-UPDRS total
Time frame: 1 year, 2 years, 3 years
Change in MDS-UPDRS sub parts
Time frame: 4 months, 1 year, 2 years, 3 years
Change in PKG Bradykinesia Score (BKS)
Time frame: 4 months, 1 year, 2 years, 3 years
Change in PKG Dyskinesia score (DKS)
Time frame: 4 months, 1 year, 2 years, 3 years
Change in Percent Time in Tremor (PTT)
Time frame: 4 months, 1 year, 2 years, 3 years
Change in Fluctuation Dyskinesia score (FDS)
Time frame: 4 months, 1 year, 2 years, 3 years
Change in Percent Time Immobile (PTI)
Time frame: 4 months, 1 year, 2 years, 3 years
Change in Parkinson's Disease Questionnaire-39 questions (PDQ-39)
Time frame: 4 months, 1 year, 2 years, 3 years
Number of Interim Visits
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Background: PubMed 30032695Pahwa 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.
- Background: PubMed 20065131Shulman 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.
- Sponsor websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raja Mehanna, MD principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
A study testing Personal KinetiGraph® (PKG®) System and Personal KinetiGraph® (PKG®) Watch in people with Parkinson Disease, run by Global Kinetics Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Outcomes using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04381065, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.