Effects of levodopa-entacapone-carbidopa intrajejunal infusion on non-motor symptoms of advanced Parkinson's disease-interim analysis of the ELEGANCE study.

The ELEGANCE study (NCT05043103) is an ongoing, non-interventional registry study collecting real-world data on long-term efficacy, safety and patient-reported outcomes following treatment with levodopa-entacapone-carbidopa intestinal gel (LECIG) infusion. To explore the effect of LECIG on non-motor symptoms (NMS) in advanced Parkinson's disease patients participating in the ELEGANCE study and using data from the planned interim analysis. The study enrolled patients prescribed LECIG as part of routine clinical care. Patients were evaluated at visit 1 (V1) before starting LECIG treatment, at V2 (after 3-6 months) and at V3 (after 6-12 months). NMS were evaluated using the validated Non-Motor Symptoms Scale (NMSS). The interim analysis included 167 LECIG-treated patients from 37 centers with at least one measure of effectiveness at V2 or V3. Mean NMSS total scores were significantly decreased from baseline at both V2 and V3 indicating an overall improvement in NMS burden. Mean scores for 7 out of the 9 individual domains were also found to have improved significantly from baseline to V2. The significant reductions in the scores for two domains, 'sleep/fatigue' and 'gastrointestinal (GI) tract', were sustained at V3. Routine use of LECIG for up to 12 months was found to reduce the overall NMS burden, a factor that is known to impact the quality of life of people with Parkinson's, with particular impact on sleep- and GI-related symptoms.