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NCT05043103

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

Sponsor: Britannia Pharmaceuticals Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

312

Start Date

2021-07-06

Completion Date

2026-09

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Lecigon® based on European Medicines Agency (EMA) SmPC

There might be different brand names in other countries

Locations (56)

Universitätsklinik für Neurologie, Medizinische Universität Graz

Graz, Austria

Abteilung für Neurologische Rehabilitation, Gailtal-Klinik

Hermagor, Austria

Universitätsklinik für Neurologie, Medizinische Universität Innsbruck

Innsbruck, Austria

Kepler Universitätsklinikum

Linz, Austria

AZ Sint-Jan

Bruges, Belgium

Antwerp University Hospital

Edegem, Belgium

Ghent University Hospital

Ghent, Belgium

University Hospital Liege

Liège, Belgium

Centre Hospitalier de Wallonie picarde (Chwapi)

Tournai, Belgium

Sveti Naum

Sofia, Bulgaria

UHC Osijek, J. Klinici za neurologiju

Osijek, Croatia

University Hospital Centre Rijeka (KBC Rijeka)

Rijeka, Croatia

Klinička bolnica Dubrava

Zagreb, Croatia

University Hospital Centre (KBC Zagreb)

Zagreb, Croatia

Masaryk university

Brno, Czechia

Fakultní nemocnice Olomouc

Olomouc, Czechia

Bispebjerg Hospital

Copenhagen, Denmark

Segeberger Kliniken GmbH Neurologisches Zentrum

Bad Segeberg, Germany

Kliniken Beelitz GmbH Neurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson

Beelitz-Heilstätten, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Uniklinik Köln

Cologne, Germany

Krankenhaus Lindenbrunn

Coppenbrügge, Germany

Klinik für Neurologie - Universitätsklinikum Essen

Essen, Germany

Zentrum für Seltene Erkrankungen Göttingen

Göttingen, Germany

Universitätsklinikum Giessen und Marburg

Marburg, Germany

Evangelisches Krankenhaus Oldenburg

Oldenburg, Germany

Klinikum Osnabrück GmbH Klinik für Neurologie

Osnabrück, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

RKU - Universitäts und Rehabilitationskliniken Ulm gGmbH

Ulm, Germany

Parkinson-Klinik Ortenau

Wolfach, Germany

Semmelweis Egyetem Neurológiai Klinika Budapest

Budapest, Hungary

Pécsi Tudományegyetem Klinikai Központ Szemészeti Klinika

Pécs, Hungary

SZTE Szent-Györgyi Albert Klinikai Közpon

Szeged, Hungary

St. Vincent's University Hospital

Dublin, Ireland

The Dublin Neurological Institute, Mater Hospital

Dublin, Ireland

University Medical Center Groningen

Groningen, Netherlands

Emergency Hospital Brasov, Spitalul Clinic Județean de Urgență Brașov

Brasov, Romania

Spitalul Universitar de Urgență Elias

Bucharest, Romania

Colentina Hospital Bucharest

Bucharest, Romania

Bucharest University Emergency Hospital

Bucharest, Romania

Fundeni Clinical Institute

Bucharest, Romania

County Emergency Hospital Cluj-Napoca

Cluj-Napoca, Romania

County Clinical Emergency Hospital of Constanta

Constanța, Romania

Emergency County Hospital Targu Mures

Târgu Mureş, Romania

Timiş County Emergency Clinical Hospital- Neurology 1

Timișoara, Romania

Timiş County Emergency Clinical Hospital

Timișoara, Romania

Department of Neurology, University Medical Centre

Ljubljana, Slovenia

Univerzitetni klinični center Maribor

Maribor, Slovenia

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital de la Princesa

Madrid, Spain

Hospital Virgen del Rocio

Seville, Spain

Sahlgrenska University Hospital

Gothenburg, Sweden

Skånes universitetssjukhus Lund

Lund, Sweden

Uppsala university hospital

Uppsala, Sweden