Objective: To present the design of and baseline patient characteristics from an ongoing global study assessing the long-term effectiveness of levodopa-carbidopa intestinal gel (LCIG, carbidopa-levodopa enteral suspension in the US) treatment in advanced Parkinson’s disease (PD) patients treated with LCIG in routine clinical care.

Background: LCIG, delivered via percutaneous gastrojejunostomy (PEG-J), has been shown to improve “Off” time, dyskinesia, non-motor symptoms (NMS), and quality of life (QoL) in advanced PD patients. However, prospective, long-term data on the effectiveness of LCIG in a large patient cohort in routine clinical practice are limited.

Methods: This is a global, multi-center, single-arm, open-label observational study examining advanced PD patients treated with LCIG over 3 years in a routine clinical care setting (DUOGLOBE), and is the first observational study of LCIG conducted in the United States. Further participating countries include Australia, Belgium, Hungary, Israel, Italy, Romania, Slovenia, Spain, and the United Kingdom. Approximately 200 patients from over 50 centers will be enrolled in accordance with local product label. The primary efficacy outcome will be the mean change from baseline to 36 months in patient-reported “Off” time. Secondary endpoints will include dyskinesia duration (UDPRS IV items) and severity (assessed with the UPDRS IV items 33+34 and the Unified Dyskinesia Rating Scale), activities of daily living (UPDRS II), motor function (UPDRS III) and fluctuations (UPDRS item 39), QoL (8-item Parkinson’s Disease Questionnaire), and NMS, specifically including sleep/daytime sleepiness assessed with the NMS Scale, Parkinson´s Disease Sleep Scale (PDSS-2) and the Epworth Sleepiness Scale. Caregiver burden, measured with the Modified Caregiver Strain Index, and healthcare resource utilization will also be examined. Adverse events will be monitored.

Results: As of December 16, 2016, baseline demographics and disease characteristics were available for 29 patients (summarized in Table 1).

Conclusions: Long-term effectiveness data on LCIG in the treatment of advanced PD patient under routine clinical care is limited, especially long-term, prospective data related to dyskinesia, NMS, QoL, and caregiver burden. The current study is designed to provide a better understanding of the long-term effectiveness profile of LCIG for the treatment of advanced PD.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-long-term-study-on-effectiveness-of-levodopa-carbidopa-intestinal-gel-treatment-in-advanced-parkinsons-disease-patients/