Clinical trial NCT04381065: Utilization of Target Ranges to Treat Persons With Parkinson's Disease by Objective Measurement Using the PKG
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Personal KinetiGraph® (PKG®) System
Objective Measurement
Lead sponsor: Global Kinetics Corporation
Sponsor class: INDUSTRY
First posted: 2020-05-08
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Change in Patient Outcomes using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: 4 months
Secondary outcomes:
measure: Responder rate for total MDS-UPDRS
timeFrame: 4 months
measure: Responder rate for PKG
timeFrame: 4 months
measure: Change in MDS-UPDRS motor endpoints
timeFrame: 4 months, 1 year, 2 years, 3 years
measure: Change in MDS-UPDRS total
timeFrame: 1 year, 2 years, 3 years
measure: Change in MDS-UPDRS sub parts
timeFrame: 4 months, 1 year, 2 years, 3 years
measure: Change in PKG Bradykinesia Score (BKS)
timeFrame: 4 months, 1 year, 2 years, 3 years
measure: Change in PKG Dyskinesia score (DKS)
timeFrame: 4 months, 1 year, 2 years, 3 years
measure: Change in Percent Time in Tremor (PTT)
timeFrame: 4 months, 1 year, 2 years, 3 years
measure: Change in Fluctuation Dyskinesia score (FDS)
timeFrame: 4 months, 1 year, 2 years, 3 years
measure: Change in Percent Time Immobile (PTI)
timeFrame: 4 months, 1 year, 2 years, 3 years
measure: Change in Parkinson's Disease Questionnaire-39 questions (PDQ-39)
timeFrame: 4 months, 1 year, 2 years, 3 years
measure: Number of Interim Visits
timeFrame: 4 months
Other outcomes:
measure: Levodopa Equivalent Dose (LED)
timeFrame: 4 months, 1 year, 2 years, 3 years
measure: PKG Patient Survey
timeFrame: 4 months, 1 year, 2 years, 3 years
measure: Healthcare Utilization
timeFrame: 4 months, 1 year, 2 years, 3 years
measure: Potential Contraindications
timeFrame: 4 months, 1 year, 2 years, 3 years
measure: Lifestyle Factors Impacted by PD
timeFrame: 4 months, 1 year, 2 years, 3 years
measure: Work Productivity and Activity Impairment
timeFrame: 4 months, 1 year, 2 years, 3 years
measure: PKG scores
timeFrame: 4 months, 1 year, 2 years, 3 years
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Raja Mehanna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.