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

Parkinson Disease Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04381065
• Other study ID #: Study 004
• Status: Withdrawn
• Phase: N/A
• Start date: June 2020
• Est. completion date: April 2026

Study information

• Verified date: January 2021
• Source: Global Kinetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 using only standard of care (SOC) (medical history, physical examination).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2026
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Personal KinetiGraph® (PKG®) System
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®) Watch
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Global Kinetics Corporation

References & Publications (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Levodopa Equivalent Dose (LED)	Levodopa Equivalent Dose (LED) at each visit	4 months, 1 year, 2 years, 3 years
Other	PKG Patient Survey	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
Other	Healthcare Utilization	Rate of protocol defined adverse events affecting health care utilization from baseline	4 months, 1 year, 2 years, 3 years
Other	Potential Contraindications	Rate of protocol defined adverse events and potential contraindications for increasing dopaminergic therapy from baseline	4 months, 1 year, 2 years, 3 years
Other	Lifestyle Factors Impacted by PD	Rate of protocol defined lifestyle factors impacted by PD	4 months, 1 year, 2 years, 3 years
Other	Work Productivity and Activity Impairment	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
Other	PKG scores	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
Primary	Change in Patient Outcomes using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	The change in MDS-UPDRS Total score at 4 months from baseline defined as sections I, II, III (per core lab measurement) and IV in PwP. The endpoint will be compared between subjects out of target at baseline for those who are treated with SOC and PKG data (PKG+ Group) versus those who are treated per SOC alone (PKG- Group).	4 months
Secondary	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).	4 months
Secondary	Responder rate for PKG	Percent "responders" by PKG (defined as BKS change of >2 point improvement)	4 months
Secondary	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).	4 months, 1 year, 2 years, 3 years
Secondary	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).	1 year, 2 years, 3 years
Secondary	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).	4 months, 1 year, 2 years, 3 years
Secondary	Change in PKG Bradykinesia Score (BKS)	Change in the PKG reported BKS from baseline. A higher score represents more severe bradykinesia.	4 months, 1 year, 2 years, 3 years
Secondary	Change in PKG Dyskinesia score (DKS)	Change in the PKG reported DKS from baseline. A higher score represents more severe dyskinesia.	4 months, 1 year, 2 years, 3 years
Secondary	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.	4 months, 1 year, 2 years, 3 years
Secondary	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.	4 months, 1 year, 2 years, 3 years
Secondary	Change in Percent Time Immobile (PTI)	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
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.	4 months, 1 year, 2 years, 3 years
Secondary	Number of Interim Visits	Number of interim visits conducted from baseline to 4 months in each arm	4 months

External Links

•   Sponsor website