A Long-term Study on Effectiveness of Levodopa-carbidopa Intestinal Gel Treatment in Advanced Parkinson’s Disease Patients (P5.066)

Objective: To present the design and baseline characteristics from an ongoing global study assessing long-term effectiveness of levodopa-carbidopa intestinal gel (LCIG) treatment in advanced Parkinson’s disease (PD) patients under routine clinical care. Background: LCIG, delivered via percutaneous gastrojejunostomy, 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 routine clinical practice are limited. Design/Methods: This global, multi-center, single-arm, open-label observational study examining advanced PD patients treated with LCIG spans 3 years in a routine clinical care setting (DUOGLOBE), and is the first observational study of LCIG conducted in the United States. Approximately 200 patients from over 50 global centers are being enrolled according to local product label. Primary efficacy outcome is the mean change in “Off” time. Secondary endpoints include dyskinesia duration and severity (assessed with UPDRS IV and the Unified Dyskinesia Rating Scale), Activities of Daily Living (UPDRS-II), motor function (UPDRS-III) and fluctuations (UPDRS item 39), QoL (8-item PD Questionnaire), and NMS, including sleep/daytime sleepiness assessed with the NMS Scale, PD Sleep Scale (PDSS-2) and the Epworth Sleepiness Scale. Caregiver burden will be measured and adverse events monitored. Results: As of December 16, 2016, baseline demographics and disease characteristics were available for 29 patients. The mean (SD) baseline age, PD duration, sleep duration, dyskinesia duration, and “Off” hours were 69.7(8.3) years, 11.7(5.1) years, 8.2(1.8) hours, 3.8(3.6) hours, and 6.4(3.4) hours, respectively. Twenty-seven( 93.1%) patients are white and 11(37.9%) are female. Conclusions: Long-term effectiveness data on LCIG in the treatment of advanced PD patients 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. Study Supported by: AbbVie Inc. Disclosure: Dr. Chaudhuri has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc., Voyager Therapeutics, and Serina Therapeutics. Dr. Chaudhuri has received research support from AbbVie Inc. Dr. Antonini has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with UCB, Boston Scientific, Boheringer Ingelheim, AbbVie Inc., Zambon. Dr. Antonini has received research support from Mundipharma. Dr. Poewe has nothing to disclose. Dr. Standaert has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Abbvie, Voyager Therapeutics, and Serina Therapeutics. Dr. Standaert has received research support from AbbVie. Dr. Odin has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc., Britannia, Boehringer-Ingelheim, Nordic Infucare, UCB and Zambon PO har received royalities from Uni-Med Verlag. Dr. Zamudio has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc. Dr. Zamudio holds stock and/or stock options in AbbVie Inc. Dr. Bergmann has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc. Dr. Bergmann holds stock and/or stock options in AbbVie Inc.