NeuralCipher Research overview
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BackgroundLevodopa-entacapone-carbidopa intestinal gel (LECIG) was introduced in 2018 as a device-aided therapy for advanced Parkinson's disease (PD).ObjectivesThe ELEGANCE study (NCT05043103) is gathering real-world data on long-term efficacy, safety and patient-reported outcomes with LECIG from 13 European countries. This article reports data from the planned interim analysis.MethodsThe study enrolled patients prescribed LECIG as part of routine clinical care. We evaluated patients at V1 before starting LECIG treatment (in seven patients V1 data were obtained retrospectively), and thereafter at V2 (3-6 months) or V3 (6-12 months).ResultsThis analysis includes 167 patients from 37 centers. Three patients from this analysis set (1.8%) discontinued the study. Mean (±SD) daily OFF-time hours (MDS-UPDRS IV item 4.3) were substantially reduced by 3.47 ± 3.56 h at V2 (baseline: 5.15 ± 3.05; P ConclusionsRoutine use of LECIG for up to 12 months provided sustained control of motor symptoms, and was well tolerated with a positive impact on QoL and high patient satisfaction.
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