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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change in Patient Outcomes using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
Subjects will remain blinded to treatment group throughout the life of the trial. Investigator and research staff will be unblinded to the treatment group as they will or will not have access to the PKG data to be incorporated into their standard of care practice.
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Patient Outcomes using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
时间窗: 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).
次要结局
- 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)