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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Global Kinetics Corporation
- Primary Endpoint
- Change in Patient Outcomes using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Number of Interim Visits(4 months)
- Change in MDS-UPDRS total(1 year, 2 years, 3 years)
- Change in MDS-UPDRS sub parts(4 months, 1 year, 2 years, 3 years)
- Change in PKG Dyskinesia score (DKS)(4 months, 1 year, 2 years, 3 years)
- Change in Fluctuation Dyskinesia score (FDS)(4 months, 1 year, 2 years, 3 years)
- Responder rate for total MDS-UPDRS(4 months)
- Change in PKG Bradykinesia Score (BKS)(4 months, 1 year, 2 years, 3 years)
- Change in Percent Time in Tremor (PTT)(4 months, 1 year, 2 years, 3 years)
- Change in Parkinson's Disease Questionnaire-39 questions (PDQ-39)(4 months, 1 year, 2 years, 3 years)
- Responder rate for PKG(4 months)
- Change in MDS-UPDRS motor endpoints(4 months, 1 year, 2 years, 3 years)
- Change in Percent Time Immobile (PTI)(4 months, 1 year, 2 years, 3 years)