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Active (not recruiting) NCT05043103

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

Conditions: Advanced Parkinson Disease

Sponsor: Britannia Pharmaceuticals Ltd.

trial.available_in: БГ
Overview
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.
Description
Study design: Non-interventional study, primary data collection. No visits or measurements will be made mandatory by the observational plan. The assignment of patients to Lecigon® not decided in advance by the study's observational plan but falls within current practice. Prescription of Lecigon® occurred before and independently of the decision to include the patient in the study. The participating centres will offer participation in the ELEGANCE study to all patients who receive treatment with Lecigon® part of routine clinical practice. From patients, who switched to treatment with Lecigon® prior to signing of informed consent, baseline data will be collected retrospectively. The planned non-interventional study aims to collect real-world data on the effectiveness and safety of Lecigon® as a therapy for advanced Parkinson´s Disease in routine care in Germany and Austria. The study will be expanded to additional European countries as soon as marketing authorisation in these countries and commercial stock will be available. Primary Objectives: * Long-term effectiveness of Lecigon® * Long-term safety of Lecigon® Secondary Objectives: * Patient non-motor symptoms and quality of life * Healthcare resource utilisation by patients
Who can participate
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with contraindications as defined in the current version of the SmPC for Lecigon® * Patients who will not be seen again for their follow up care at the investigator's site after commencement of Lecigon® therapy * 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
Interventions
Lecigon® based on European Medicines Agency (EMA) SmPC
COMBINATION_PRODUCT
Locations 57
Austria (4)
Universitätsklinik für Neurologie, Medizinische Universität Graz
Graz
Abteilung für Neurologische Rehabilitation, Gailtal-Klinik
Hermagor
Universitätsklinik für Neurologie, Medizinische Universität Innsbruck
Innsbruck
Kepler Universitätsklinikum
Linz
Belgium (5)
AZ Sint-Jan
Bruges
Antwerp University Hospital
Edegem
Ghent University Hospital
Ghent
University Hospital Liege
Liège
Centre Hospitalier de Wallonie picarde (Chwapi)
Tournai
Bulgaria (1)
Sveti Naum
Sofia
Croatia (4)
UHC Osijek, J. Klinici za neurologiju
Osijek
University Hospital Centre Rijeka (KBC Rijeka)
Rijeka
Klinička bolnica Dubrava
Zagreb
University Hospital Centre (KBC Zagreb)
Zagreb
Czech Republic (2)
Masaryk university
Brno
Fakultní nemocnice Olomouc
Olomouc
Denmark (1)
Bispebjerg Hospital
Copenhagen
Germany (14)
Segeberger Kliniken GmbH Neurologisches Zentrum
Bad Segeberg
Kliniken Beelitz GmbH Neurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson
Beelitz-Heilstätten
Charité - Universitätsmedizin Berlin
Berlin
Uniklinik Köln
Cologne
Krankenhaus Lindenbrunn
Coppenbrügge
Klinik für Neurologie - Universitätsklinikum Essen
Essen
Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
Freiburg im Breisgau
Zentrum für Seltene Erkrankungen Göttingen
Göttingen
Universitätsklinikum Giessen und Marburg
Marburg
Evangelisches Krankenhaus Oldenburg
Oldenburg
Klinikum Osnabrück GmbH Klinik für Neurologie
Osnabrück
Universitätsklinikum Tübingen
Tübingen
RKU - Universitäts und Rehabilitationskliniken Ulm gGmbH
Ulm
Parkinson-Klinik Ortenau
Wolfach
Hungary (3)
Semmelweis Egyetem Neurológiai Klinika Budapest
Budapest
Pécsi Tudományegyetem Klinikai Központ Szemészeti Klinika
Pécs
SZTE Szent-Györgyi Albert Klinikai Közpon
Szeged
Ireland (2)
St. Vincent's University Hospital
Dublin
The Dublin Neurological Institute, Mater Hospital
Dublin
Netherlands (1)
University Medical Center Groningen
Groningen
Romania (10)
Emergency Hospital Brasov, Spitalul Clinic Județean de Urgență Brașov
Brasov
Spitalul Universitar de Urgență Elias
Bucharest
Colentina Hospital Bucharest
Bucharest
Bucharest University Emergency Hospital
Bucharest
Fundeni Clinical Institute
Bucharest
County Emergency Hospital Cluj-Napoca
Cluj-Napoca
County Clinical Emergency Hospital of Constanta
Constanța
Emergency County Hospital Targu Mures
Târgu Mureş
Timiş County Emergency Clinical Hospital- Neurology 1
Timișoara
Timiş County Emergency Clinical Hospital
Timișoara
Slovenia (2)
Department of Neurology, University Medical Centre
Ljubljana
Univerzitetni klinični center Maribor
Maribor
Spain (5)
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitario Ramón y Cajal
Madrid
Hospital Clínico San Carlos
Madrid
Hospital de la Princesa
Madrid
Hospital Virgen del Rocio
Seville
Sweden (3)
Sahlgrenska University Hospital
Gothenburg
Skånes universitetssjukhus Lund
Lund
Uppsala university hospital
Uppsala
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
06.07.2021
Completion date
01.09.2026
Registry ID
NCT05043103
Source
clinicaltrials.gov
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