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

Warnecke, Tobias ; Odin, Per LU orcid ; García-Ramos, Rocío ; Lopez, Lydia ; Tulbă, Delia ; Dan, Traian Flavius ; Jianu, Dragos Catalin ; Rožanković, Petra Bago and van Laar, Teus (2025) In Journal of Neural Transmission
Abstract

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... (More)

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.

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author
; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
epub
subject
keywords
Advanced Parkinson’s disease, Clinical practice, Levodopa–entacapone–carbidopa intestinal gel, Non-motor symptoms, Non-Motor Symptoms Scale
in
Journal of Neural Transmission
publisher
Springer
external identifiers
  • scopus:105018526596
  • pmid:41051549
ISSN
0300-9564
DOI
10.1007/s00702-025-03033-8
language
English
LU publication?
yes
additional info
Publisher Copyright: © The Author(s), under exclusive licence to Springer-Verlag GmbH Austria, part of Springer Nature 2025.
id
a599bb47-e5af-46de-a1d0-922ddb3e3594
date added to LUP
2026-01-26 10:40:55
date last changed
2026-01-27 02:25:12
@article{a599bb47-e5af-46de-a1d0-922ddb3e3594,
  abstract     = {{<p>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.</p>}},
  author       = {{Warnecke, Tobias and Odin, Per and García-Ramos, Rocío and Lopez, Lydia and Tulbă, Delia and Dan, Traian Flavius and Jianu, Dragos Catalin and Rožanković, Petra Bago and van Laar, Teus}},
  issn         = {{0300-9564}},
  keywords     = {{Advanced Parkinson’s disease; Clinical practice; Levodopa–entacapone–carbidopa intestinal gel; Non-motor symptoms; Non-Motor Symptoms Scale}},
  language     = {{eng}},
  publisher    = {{Springer}},
  series       = {{Journal of Neural Transmission}},
  title        = {{Effects of levodopa–entacapone–carbidopa intrajejunal infusion on non-motor symptoms of advanced Parkinson’s disease—interim analysis of the ELEGANCE study}},
  url          = {{http://dx.doi.org/10.1007/s00702-025-03033-8}},
  doi          = {{10.1007/s00702-025-03033-8}},
  year         = {{2025}},
}