Fact CheckerSign in

NCT05043103Active, not recruiting

Long-Term Observational Study on Effectiveness and Safety of Lecigon in Patients With Advanced Parkinson's Disease

ELEGANCE - A Non-interventional Study on Long-term Effectiveness and Safety of Levodopa-Entacapone-Carbidopa Intestinal Gel (Lecigon®) in Patients With Advanced Parkinson's Disease in Routine Care

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

This observational study is designed to collect data on the use of the drug Lecigon® in daily clinical practice. The study is organised and funded by a pharmaceutical company called Britannia Pharmaceuticals Ltd (Britannia). Lecigon® is prescribed by physicians in advanced Parkinson's disease when patients suffer from uncontrollable fluctuations in mobility, so-called motor fluctuations, which cannot be adjusted well with oral treatment, i.e. medication for swallowing. In this study, data on the effect and possible side effects from everyday treatment with Lecigon® will be collected and scientifically evaluated. The study is intended to supplement the results of previous clinical studies with clinical data in routine medical care, collected from approximately 300 patients.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
312 (actual)
First submitted
29 Jul 2021
Start date
6 Jul 2021
Primary completion date
7 Oct 2026
Lead sponsor
Britannia Pharmaceuticals Ltd.
NCT number
NCT05043103

What you commit to

  • Study type: Observational
  • Participants enrolled: 312
  • From 6 Jul 2021 to the primary completion date, 7 Oct 2026
  • 57 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who will not be seen again for their follow up care at the investigator's site after commencement of Lecigon® therapy

Other illness

  • Patients with pump placement or pump use issues, e.g. patients with acute severe illness, patients unable to perform pump therapy, and in case of lacking compliance due to severe dementia, agitation or alcohol abuse

Other

  • Patients with contraindications as defined in the current version of the SmPC for Lecigon®

Who the study is looking for

  • Adult Patients (18 years old and over) with Advanced Parkinson Disease already under treatment with Lecigon® (for up to 3 months before giving informed consent) in accordance with the Summary of Product Characteristics (SmPC)
  • Patients or legal representative must have signed informed consent to participate in the study
  • Patients are not taking part in another clinical (interventional) study at the same time

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (57)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitätsklinik für Neurologie, Medizinische Universität Graz
Coordinator of this site? Confirm its status
GrazAustriaUnknown status
Abteilung für Neurologische Rehabilitation, Gailtal-Klinik
Coordinator of this site? Confirm its status
HermagorAustriaUnknown status
Universitätsklinik für Neurologie, Medizinische Universität Innsbruck
Coordinator of this site? Confirm its status
InnsbruckAustriaUnknown status
Kepler Universitätsklinikum
Coordinator of this site? Confirm its status
LinzAustriaUnknown status
AZ Sint Jan
Coordinator of this site? Confirm its status
BrugesBelgiumUnknown status
Antwerp University Hospital
Coordinator of this site? Confirm its status
EdegemBelgiumUnknown status
Ghent university hospital
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status
University Hospital Liege
Coordinator of this site? Confirm its status
LiègeBelgiumUnknown status
Centre Hospitalier de Wallonie picarde (Chwapi)
Coordinator of this site? Confirm its status
TournaiBelgiumUnknown status
Sveti Naum
Coordinator of this site? Confirm its status
SofiaBulgariaUnknown status
Masaryk university
Coordinator of this site? Confirm its status
BrnoCzechiaUnknown status
Fakultni nemocnice Olomouc
Coordinator of this site? Confirm its status
OlomoucCzechiaUnknown status
Segeberger Kliniken GmbH Neurologisches Zentrum
Coordinator of this site? Confirm its status
Bad SegebergGermanyUnknown status
Kliniken Beelitz GmbH Neurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson
Coordinator of this site? Confirm its status
Beelitz-HeilstättenGermanyUnknown status
Charité Universitätsmedizin Berlin
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
Uniklinik Köln
Coordinator of this site? Confirm its status
CologneGermanyUnknown status
Krankenhaus Lindenbrunn
Coordinator of this site? Confirm its status
CoppenbrüggeGermanyUnknown status
Klinik für Neurologie - Universitätsklinikum Essen
Coordinator of this site? Confirm its status
EssenGermanyUnknown status
Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
Coordinator of this site? Confirm its status
Freiburg im BreisgauGermanyUnknown status
Zentrum für Seltene Erkrankungen Göttingen
Coordinator of this site? Confirm its status
GöttingenGermanyUnknown status
Universitätsklinikum Giessen und Marburg
Coordinator of this site? Confirm its status
MarburgGermanyUnknown status
Evangelisches Krankenhaus Oldenburg
Coordinator of this site? Confirm its status
OldenburgGermanyUnknown status
Klinikum Osnabrück GmbH Klinik für Neurologie
Coordinator of this site? Confirm its status
OsnabrückGermanyUnknown status
Universitätsklinikum Tübingen
Coordinator of this site? Confirm its status
TübingenGermanyUnknown status
RKU - Universitäts und Rehabilitationskliniken Ulm gGmbH
Coordinator of this site? Confirm its status
UlmGermanyUnknown status
Parkinson-Klinik Ortenau
Coordinator of this site? Confirm its status
WolfachGermanyUnknown status
Bispebjerg Hospital
Coordinator of this site? Confirm its status
CopenhagenDenmarkUnknown status
Hospital de la Santa Creu i Sant Pau
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Hospital de La Princesa
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Hospital Universitario Ramón y Cajal
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Hospital Clínico San Carlos
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Hospital Virgen Del Rocio
Coordinator of this site? Confirm its status
SevilleSpainUnknown status
UHC Osijek, J. Klinici za neurologiju
Coordinator of this site? Confirm its status
OsijekCroatiaUnknown status
University Hospital Centre Rijeka (KBC Rijeka)
Coordinator of this site? Confirm its status
RijekaCroatiaUnknown status
Klinička bolnica Dubrava
Coordinator of this site? Confirm its status
ZagrebCroatiaUnknown status
University Hospital Centre (KBC Zagreb)
Coordinator of this site? Confirm its status
ZagrebCroatiaUnknown status
Semmelweis Egyetem Neurológiai Klinika Budapest
Coordinator of this site? Confirm its status
BudapestHungaryUnknown status
Pécsi Tudományegyetem Klinikai Központ Szemészeti Klinika
Coordinator of this site? Confirm its status
PécsHungaryUnknown status
SZTE Szent-Györgyi Albert Klinikai Közpon
Coordinator of this site? Confirm its status
SzegedHungaryUnknown status
The Dublin Neurological Institute, Mater Hospital
Coordinator of this site? Confirm its status
DublinIrelandUnknown status
St Vincent's University Hospital
Coordinator of this site? Confirm its status
DublinIrelandUnknown status
University Medical Center Groningen
Coordinator of this site? Confirm its status
GroningenNetherlandsUnknown status
Emergency Hospital Brasov, Spitalul Clinic Județean de Urgență Brașov
Coordinator of this site? Confirm its status
BrasovRomaniaUnknown status
Fundeni Clinical Institute
Coordinator of this site? Confirm its status
BucharestRomaniaUnknown status
Bucharest University Emergency Hospital
Coordinator of this site? Confirm its status
BucharestRomaniaUnknown status
Spitalul Universitar de Urgență Elias
Coordinator of this site? Confirm its status
BucharestRomaniaUnknown status
Colentina Hospital Bucharest
Coordinator of this site? Confirm its status
BucharestRomaniaUnknown status
County Emergency Hospital Cluj-Napoca
Coordinator of this site? Confirm its status
Cluj-NapocaRomaniaUnknown status
County Clinical Emergency Hospital of Constanta
Coordinator of this site? Confirm its status
ConstanțaRomaniaUnknown status
Emergency County Hospital Targu Mures
Coordinator of this site? Confirm its status
Târgu MureşRomaniaUnknown status
Timiş County Emergency Clinical Hospital- Neurology 1
Coordinator of this site? Confirm its status
TimișoaraRomaniaUnknown status
Timiş County Emergency Clinical Hospital
Coordinator of this site? Confirm its status
TimișoaraRomaniaUnknown status
Sahlgrenska University Hospital
Coordinator of this site? Confirm its status
GothenburgSwedenUnknown status
Skånes Universitetssjukhus Lund
Coordinator of this site? Confirm its status
LundSwedenUnknown status
Uppsala University Hospital
Coordinator of this site? Confirm its status
UppsalaSwedenUnknown status
Department of Neurology, University Medical Centre
Coordinator of this site? Confirm its status
LjubljanaSloveniaUnknown status
Univerzitetni klinični center Maribor
Coordinator of this site? Confirm its status
MariborSloveniaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.