Using Objective Measurement Via Wearable Sensors To Evaluate Real-world Effectiveness Of Carbidopa/Levodopa Enteral Suspension For Managing Motor Fluctuations: PROviDE Study Design And Baseline Characteristics (P3.037)

Objective: To evaluate the impact of Carbidopa/Levodopa Enteral Suspension (CLES) on motor symptoms using wearable sensors and correlate the objective measures with results of patient-reported outcomes. Background: An emerging class of wearable sensors and big data analytics enable an objective evaluation of real-world evidence on treatment efficacy. Design/Methods: PROviDE is a US-based, prospective, longitudinal observational study to evaluate long-term comparative effectiveness of CLES in eligible patients. As part of a sub-study, motor symptoms are also being evaluated using a validated wearable sensor system which includes two sensors. The system continuously measures tremor, dyskinesia, mobility and arm swing. Endpoints from wearable sensors are collected at periodic intervals during a 4 month period (~1 month before treatment and ~3 months after treatment period). Results: The PROviDE wearable sensor sub-study has currently enrolled 13/50 planned patients. From the enrolled patients, 53.85% (n=7) enrollees were male, 53.85% (n=7) enrollees had a college education or higher. The mean age of the enrollees was 69.38 (SD: 9.84) years. Additional details presented will highlight nuances of study design aiding a home-based real-world evidence generated from wearable sensors and patient-reported outcomes. Treatment effect will be presented based on wearable sensors data collected as a weekly set of back-to-back days. Additionally, correlations between the objective and subjective measures of motor symptoms, quality of life and activities of daily living will be presented. Conclusions: The PROviDE study is one of the first longitudinal studies to assess the long-term efficacy of an approved therapy using wearable sensors in Parkinson disease. The study will enable objective, high frequency assessments of the efficacy of an approved therapy outside the clinic. This study lays the foundation for incorporation of wearable sensors in future clinical trials of promising PD therapeutics. Study Supported by: This study was supported by AbbVie, Inc. AbbVie participated in study design, research, data collection, analysis and interpretation of data, writing, reviewing, and approving the publication. Funding statement : Financial support for the study was provided by AbbVie. AbbVie participated in the interpretation of the data, review, and approval of the abstract. All authors contributed to the development of the abstract and maintained control over the final content. Disclosure: Dr. Pahwa has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Abbvie, ACADIA, Acorda, Adamas, Cynapses, Global Kinetics, Lundbeck, Neurocrine, Pfizer, Sage, Sunovion, Teva Neuroscience and US World Meds. Dr. Pahwa has received research support from Abbvie, Adamas, Avid, Biotie, Boston Scientific, Civitas, Cynapses, Kyowa, National Parkinson Foundation, NIH/NINDS, Parkinson Study Group. Dr. Dorsey has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie and MC10. Dr. Dorsey has received research support from Great Lakes Neurotechnologies. Dr. Pan has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie, UBC. Dr. Pan has received research support from AbbVie. Dr. van Norman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with UBC (Employee). Dr. van Norman holds stock and/or stock options in AbbVie, UBC, which sponsored research in which Dr. van Norman was involved as an investigator. Dr. van Norman has received research support from AbbVie. Dr. Marshall has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie (Employment). Dr. Marshall holds stock and/or stock options in AbbVie, which sponsored research in which Dr. Marshall was involved as an investigator. Dr. Heldman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Great Lakes NeuroTechnologies (Employment). Dr. Heldman has received research support from AbbVie. Dr. Jalundhwala has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie (Employment). Dr. Jalundhwala holds stock and/or stock options in AbbVie, which sponsored research in which Dr. Jalundhwala was involved as an investigator.