| Primary | Change in Patient Outcomes Using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | The change in total MDS-UPDRS score at 4 months from baseline defined as sections I, II, III and IV in Patients with Parkinson's. The endpoint will be compared between those who are treated with standard of care and access to the PKG (PKG+ Group) and those who are treated per standard of care alone (PKG- Group). The 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). | The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. Subjects were excluded from the analysis if they did not complete the 4 month Follow-up Visit or did not complete all parts of the MDS-UPDRS assessment at the Baseline and/or 4 month Follow-up Visit. | Posted | | Mean | Standard Deviation | score on a scale | | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | | | | ID | Title | Description |
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| OG000 | 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 "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
- A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
- An application to configure the data logger and transfer the acquired data at the end of a recording.
Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | | OG001 | PKG- Group | 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. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
- A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
- An application to configure the data logger and transfer the acquired data at the end of a recording.
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| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0000.9± 19.9
- OG0010.8± 12.0
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| Secondary | Percentage of Responders for Total MDS-UPDRS | Percent "responders" for total MDS-UPDRS based on a minimal clinically important change of 4.3 (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 primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. | Posted | | Count of Participants | | Participants | | 4 month Follow-up Visit | | | | ID | Title | Description |
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| OG000 | 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 "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
- A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
- An application to configure the data logger and transfer the acquired data at the end of a recording.
Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. |
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| Secondary | 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. | The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. | Posted | | Mean | Standard Deviation | score on a scale | | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | | | | ID | Title | Description |
|---|
| OG000 | 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 "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
- A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
- An application to configure the data logger and transfer the acquired data at the end of a recording.
Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. |
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| Secondary | Change in MDS-UPDRS Total From Baseline | The change in total MDS-UPDRS score at 4 months from baseline defined as sections I, II, III and IV in Patients with Parkinson's. The endpoint will be compared between those who are treated with standard of care and access to the PKG (PKG+ Group) and those who are treated per standard of care alone (PKG- Group). The 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). | This Secondary Outcome Measure was not evaluated because the study was discontinued after completion of the 4-month Follow-up Visit. Subjects did not complete the 1, 2, or 3-Year Annual Follow-up Visits. | Posted | | | | | | From Baseline to the 1, 2 and 3-Year Annual Visits | | | | ID | Title | Description |
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| OG000 | 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 "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
- A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
- An application to configure the data logger and transfer the acquired data at the end of a recording.
Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. |
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| Secondary | Change in MDS-UPDRS Sub Part I | Change in sub part I of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part I assesses the non-motor impact of Parkinson's disease and contains 13 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part I is 0 and the maximum score is 52. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms). | The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. | Posted | | Mean | Standard Deviation | score on a scale | | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | | | | ID | Title | Description |
|---|
| OG000 | 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 "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
- A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
- An application to configure the data logger and transfer the acquired data at the end of a recording.
Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. |
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| Secondary | Change in PKG Bradykinesia Score (BKS) | Change in the PKG reported scores BKS from baseline. Reported on a scale from 0-80. The higher the number, the more severe the bradykinesia. | The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. | Posted | | Mean | Standard Deviation | score on a scale | | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | | | | ID | Title | Description |
|---|
| OG000 | 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 "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
- A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
- An application to configure the data logger and transfer the acquired data at the end of a recording.
Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. |
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| Secondary | Change in PKG Dyskinesia Score (DKS) | Change in the PKG reported scores DKS from baseline. Reported on a scale of 0-355 with the higher the score, the more severe the dyskinesia. | The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. | Posted | | Mean | Standard Deviation | score on a scale | | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | | | | ID | Title | Description |
|---|
| OG000 | 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 "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
- A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
- An application to configure the data logger and transfer the acquired data at the end of a recording.
Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. |
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| Secondary | Change in PKG Fluctuation Score (FDS) | Change in the PKG reported scores FDS from baseline reported as a score of 0-45. The higher the score, the more severe the fluctuation. | The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. | Posted | | Mean | Standard Deviation | score on a scale | | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | | | | ID | Title | Description |
|---|
| OG000 | 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 "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
- A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
- An application to configure the data logger and transfer the acquired data at the end of a recording.
Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. |
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| Secondary | Change in PKG Percent Time Tremor (PTT) | Change in the PKG reported percent time in tremor from baseline, max 100% | The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. | Posted | | Mean | Standard Deviation | percentage of time with tremor | | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | | | | ID | Title | Description |
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| OG000 | 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 "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
- A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
- An application to configure the data logger and transfer the acquired data at the end of a recording.
Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. |
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| Secondary | Change in Levodopa Equivalent Dose (LED) | Change in LED from baseline to 4-months | The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. | Posted | | Mean | Standard Deviation | levodopa equivalent dose | | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | | | | ID | Title | Description |
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| OG000 | 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 "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
- A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
- An application to configure the data logger and transfer the acquired data at the end of a recording.
Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. |
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| Secondary | PKG Patient Survey | Analyze PKG usability with the PKG Patient reported survey, specifically the percentage of subjects that strongly agree when asked if they would be willing to use the PKG again to assist in the management of Parkinson's disease. Questions in the survey 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. | The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. | Posted | | Count of Participants | | Participants | | Outcome measure evaluated at the 4-month Follow-up Visit | | | | ID | Title | Description |
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| OG000 | 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 "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
- A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
- An application to configure the data logger and transfer the acquired data at the end of a recording.
Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. |
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| Secondary | Change in MDS-UPDRS Sub Part II | Change in sub part II of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part II assesses the non-motor impact of Parkinson's disease and contains 13 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part II is 0 and the maximum score is 52. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms). | The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. | Posted | | Mean | Standard Deviation | score on a scale | | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | | | | ID | Title | Description |
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| OG000 | 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 "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
- A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
- An application to configure the data logger and transfer the acquired data at the end of a recording.
Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. |
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| Secondary | Change in MDS-UPDRS Sub Part III | Change in sub part III of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part III assesses the motor impact of Parkinson's disease and contains 33 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part III is 0 and the maximum score is 132. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms). | The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. | Posted | | Mean | Standard Deviation | score on a scale | | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | | | | ID | Title | Description |
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| OG000 | 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 "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
- A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
- An application to configure the data logger and transfer the acquired data at the end of a recording.
Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. |
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| Secondary | Change in MDS-UPDRS Sub Part IV | Change in Part IV of the MDS-UPDRS from Baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part IV evaluates motor symptoms and contains 6 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part IV is 0 and the maximum score is 24. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms). | The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. | Posted | | Mean | Standard Deviation | score on a scale | | From Baseline to the 4-month Follow-up Visit | | | | ID | Title | Description |
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| OG000 | 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 "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
- A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
- An application to configure the data logger and transfer the acquired data at the end of a recording.
Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. |
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