INTRODUCTION: This registry evaluated the 24-month safety and efficacy of levodopa-carbidopa intestinal gel (LCIG) treatment in advanced Parkinson's disease (PD) patients under routine clinical care. METHODS: Motor fluctuations, dyskinesia, non-motor symptoms, quality of life, and safety were evaluated. Observations were fully prospective for treatment-naïve patients (60% of patients) and partially retrospective for patients with ≤12 months of pre-treatment with LCIG (40% of patients). Hours of "On" and "Off" time were assessed with a modified version of the Unified Parkinson's Disease Rating Scale part IV items 32 and 39. RESULTS: Overall, 375 patients were enrolled by 75 movement disorder centers in 18 countries and 258 patients completed the registry. At 24 months LCIG treatment led to significant reductions from baseline in "Off" time (hours/day) (mean ± SD = -4.1 ± 3.5, P < 0.001), "On" time with dyskinesia (hours/day) (-1.1 ± 4.8, P = 0.006), Non-Motor Symptom Scale total (-16.7 ± 43.2, P < 0.001) and individual domains scores, and Parkinson's Disease Questionnaire-8 item total score (-7.1 ± 21.0, P < 0.001). Adverse events deemed to have a possible/probable causal relationship to treatment drug/device were reported in 194 (54%) patients; the most frequently reported were decreased weight (6.7%), device related infections (5.9%), device dislocations (4.8%), device issues (4.8%), and polyneuropathy (4.5%). CONCLUSIONS: LCIG treatment led to sustained improvements in motor fluctuations, non-motor symptoms particularly sleep/fatigue, mood/cognition and gastrointestinal domains, as well as quality of life in advanced PD patients over 24 months. Safety events were consistent with the established safety profile of LCIG.

AbbVie Inc North Chicago IL USA

Clinical and Provincial Hospital of Barcelona Barcelona Spain

Department of Neurology Center of Clinical Neurosciences Charles University Prague General University Hospital Prague Prague Czech Republic

Department of Neurosciences University of Padua Italy

King's College and King's College Hospital London United Kingdom

Lindenbrunn Hospital Coppenbrügge Germany

Lund University Lund Sweden

Medical University of Innsbruck Innsbruck Austria

University Hospital Antwerp Antwerp Belgium; Michigan State University Mercy Health Hauenstein Neurosciences Grand Rapids MI USA

University Medical Center Ljubljana Ljubljana Slovenia

University of Medicine and Pharmacy Tirgu Mures Emergency Clinical County Hospital Mures Tîrgu Mureş Romania

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Levodopa-carbidopa intestinal gel in advanced Parkinson's disease: long-term results from COSMOS

Concomitant Medication Usage with Levodopa-Carbidopa Intestinal Gel: Results from the COSMOS Study