BOOST-PD - Better On-time Observations of Motor Fluctuations Using Wearable Sensor Technology: A Naturalistic Study on IPX-203 for Parkinson's Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Primary Endpoint
研究概览
简要总结
The purpose of this study is to evaluate the effect of IPX203 (Crexont®) - the newest extended-release levodopa formulation - on the duration and quality of good on time, using a wearable device to monitor symptoms. 'Good on time' refers to a period (minutes to hours) when a patient experiences optimal symptom control due to effective medication and has better overall functioning without troublesome dyskinesias. The change in the duration and quality of on-time will be measured by a wearable device placed on your wrist called KinesiaU.
详细描述
This research is being done because a new, longer-duration formulation of levodopa named IPX203 (brand name: Crexont®) has been recently approved by the FDA. The pivotal study on this drug demonstrated that IPX203 significantly increased the daily good on-time compared to immediate release carbidopa-levodopa (IR CD-LD), where good on-time is the time when the Parkinson's symptoms are improved without troublesome dyskinesias. In that study, the participants were taking IPX203 a mean of 3 times per day which still left a mean of 4.18 hours of off-time per day (when symptoms returned). These data were based on diaries filled out by the participants.
The aim of the study is to expand the current knowledge on IPX203, analyzing the changes in good on-time after careful and tailored adjustments, as in the real-world setting. This will be done with the assistance of a wearable device to obtain objective data. Additional variables such as changes in the tremor scores, conversion from other drugs such as Rytary and COMT inhibitors, and the difference between starting and final IPX203 doses will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Participant is 40 years or older
- •Diagnosed with idiopathic Parkinson's disease and is deemed to be levodopa responsive
- •Baseline MDS-UPDRS score in OFF-state is > 20
- •Patient is being treated with a stable regimen of CD-LD for at least four weeks
- •The minimum most frequent levodopa dosing is 100 mg if using IR CD-LD and 195mg if using Rytary; maximum levodopa dosing per day is 1200 mg if using IR CD-LD, 1000 mg if associated with a COMT inhibitor, and 2400 mg if using Rytary
- •Participant can be on stable doses of any levodopa adjunctive medications and/or psychotropic medications for at least 30 days
- •Participant experiences off time estimated at 2 hours or more per day; participant can comply with the wearable kinematic device.
排除标准
- •- Participants with severe dyskinesia as defined by a score of 4 on Question 4.1 (time spent with dyskinesia) of UPDRS IV
- •Currently on device-aided therapies for advanced PD
- •Using controlled-release CD-LD apart from a single daily bedtime dose
- •Using "on demand" therapy unless willing to stop it during the study period
- •Have a diagnosis hypothesis of dopamine dysregulation syndrome or evidence of significant levodopa-related complications including orthostatic hypotension or psychosis
- •History of dementia or MOCA score lower than 23
- •Significant medical history might interfere significantly with study participation
- •Being enrolled in other clinical trials involving active medication interventions.
研究组 & 干预措施
Intervention Arm
The intervention arm will be patients converting to shorter dose intervals of Crexont (IPX203) and allowing for higher dosing frequency, as practiced in real-world settings, combined with objective monitoring of on-time periods and other parameters using the KinesiaU device, could reveal additional benefits of Crexont (IPX203) treatment.
干预措施: CREXONT ER (Drug)
结局指标
主要结局
Primary Endpoint
时间窗: 8 weeks
Mean change in the average duration of good on-time from baseline to end of study
次要结局
- Secondary Endpoint(8 weeks)
研究者
Hubert Fernandez
Center Director
The Cleveland Clinic