- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04381065
Utilization of Target Ranges to Treat Persons With Parkinson's Disease by Objective Measurement Using the PKG (TARGET-PwP)
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PKG+ Group
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.
|
The Personal KinetiGraph (PKG®) System consists of the following:
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. |
Placebo Comparator: PKG- Group
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.
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The Personal KinetiGraph (PKG®) System consists of the following:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Responder rate for total MDS-UPDRS
Time Frame: 4 months
|
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).
|
4 months
|
Responder rate for PKG
Time Frame: 4 months
|
Percent "responders" by PKG (defined as BKS change of >2 point improvement)
|
4 months
|
Change in MDS-UPDRS motor endpoints
Time Frame: 4 months, 1 year, 2 years, 3 years
|
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).
|
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 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).
|
1 year, 2 years, 3 years
|
Change in MDS-UPDRS sub parts
Time Frame: 4 months, 1 year, 2 years, 3 years
|
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).
|
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 the PKG reported BKS from baseline.
A higher score represents more severe bradykinesia.
|
4 months, 1 year, 2 years, 3 years
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Change in PKG Dyskinesia score (DKS)
Time Frame: 4 months, 1 year, 2 years, 3 years
|
Change in the PKG reported DKS from baseline.
A higher score represents more severe dyskinesia.
|
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 the PKG reported PTT from baseline, max 100%.
A PTT of >1% indicates that tremor is present.
|
4 months, 1 year, 2 years, 3 years
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Change in Fluctuation Dyskinesia score (FDS)
Time Frame: 4 months, 1 year, 2 years, 3 years
|
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.
|
4 months, 1 year, 2 years, 3 years
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Change in Percent Time Immobile (PTI)
Time Frame: 4 months, 1 year, 2 years, 3 years
|
Change in the PKG reported PTI from baseline, max 100%.
A PTI of >5% is considered high.
|
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
|
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.
|
4 months, 1 year, 2 years, 3 years
|
Number of Interim Visits
Time Frame: 4 months
|
Number of interim visits conducted from baseline to 4 months in each arm
|
4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levodopa Equivalent Dose (LED)
Time Frame: 4 months, 1 year, 2 years, 3 years
|
Levodopa Equivalent Dose (LED) at each visit
|
4 months, 1 year, 2 years, 3 years
|
PKG Patient Survey
Time Frame: 4 months, 1 year, 2 years, 3 years
|
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.
|
4 months, 1 year, 2 years, 3 years
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Healthcare Utilization
Time Frame: 4 months, 1 year, 2 years, 3 years
|
Rate of protocol defined adverse events affecting health care utilization from baseline
|
4 months, 1 year, 2 years, 3 years
|
Potential Contraindications
Time Frame: 4 months, 1 year, 2 years, 3 years
|
Rate of protocol defined adverse events and potential contraindications for increasing dopaminergic therapy from baseline
|
4 months, 1 year, 2 years, 3 years
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Lifestyle Factors Impacted by PD
Time Frame: 4 months, 1 year, 2 years, 3 years
|
Rate of protocol defined lifestyle factors impacted by PD
|
4 months, 1 year, 2 years, 3 years
|
Work Productivity and Activity Impairment
Time Frame: 4 months, 1 year, 2 years, 3 years
|
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.
|
4 months, 1 year, 2 years, 3 years
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PKG scores
Time Frame: 4 months, 1 year, 2 years, 3 years
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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.
|
4 months, 1 year, 2 years, 3 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Raja Mehanna, MD, The University of Texas Health Science Center, Houston
Publications and helpful links
General 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Study 004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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