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.
- Diseases
- Parkinson disease
- 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
Sites (57)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinik für Neurologie, Medizinische Universität Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Abteilung für Neurologische Rehabilitation, Gailtal-Klinik Coordinator of this site? Confirm its status | Hermagor | Austria | Unknown status |
| Universitätsklinik für Neurologie, Medizinische Universität Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Unknown status |
| Kepler Universitätsklinikum Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| AZ Sint Jan Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| Ghent university hospital Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| University Hospital Liege Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Centre Hospitalier de Wallonie picarde (Chwapi) Coordinator of this site? Confirm its status | Tournai | Belgium | Unknown status |
| Sveti Naum Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Masaryk university Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Fakultni nemocnice Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| Segeberger Kliniken GmbH Neurologisches Zentrum Coordinator of this site? Confirm its status | Bad Segeberg | Germany | Unknown status |
| Kliniken Beelitz GmbH Neurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson Coordinator of this site? Confirm its status | Beelitz-Heilstätten | Germany | Unknown status |
| Charité Universitätsmedizin Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Uniklinik Köln Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Krankenhaus Lindenbrunn Coordinator of this site? Confirm its status | Coppenbrügge | Germany | Unknown status |
| Klinik für Neurologie - Universitätsklinikum Essen Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| Zentrum für Seltene Erkrankungen Göttingen Coordinator of this site? Confirm its status | Göttingen | Germany | Unknown status |
| Universitätsklinikum Giessen und Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Unknown status |
| Evangelisches Krankenhaus Oldenburg Coordinator of this site? Confirm its status | Oldenburg | Germany | Unknown status |
| Klinikum Osnabrück GmbH Klinik für Neurologie Coordinator of this site? Confirm its status | Osnabrück | Germany | Unknown status |
| Universitätsklinikum Tübingen Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| RKU - Universitäts und Rehabilitationskliniken Ulm gGmbH Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| Parkinson-Klinik Ortenau Coordinator of this site? Confirm its status | Wolfach | Germany | Unknown status |
| Bispebjerg Hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital de La Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Virgen Del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| UHC Osijek, J. Klinici za neurologiju Coordinator of this site? Confirm its status | Osijek | Croatia | Unknown status |
| University Hospital Centre Rijeka (KBC Rijeka) Coordinator of this site? Confirm its status | Rijeka | Croatia | Unknown status |
| Klinička bolnica Dubrava Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| University Hospital Centre (KBC Zagreb) Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| Semmelweis Egyetem Neurológiai Klinika Budapest Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Pécsi Tudományegyetem Klinikai Központ Szemészeti Klinika Coordinator of this site? Confirm its status | Pécs | Hungary | Unknown status |
| SZTE Szent-Györgyi Albert Klinikai Közpon Coordinator of this site? Confirm its status | Szeged | Hungary | Unknown status |
| The Dublin Neurological Institute, Mater Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| St Vincent's University Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Emergency Hospital Brasov, Spitalul Clinic Județean de Urgență Brașov Coordinator of this site? Confirm its status | Brasov | Romania | Unknown status |
| Fundeni Clinical Institute Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Bucharest University Emergency Hospital Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Spitalul Universitar de Urgență Elias Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Colentina Hospital Bucharest Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| County Emergency Hospital Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| County Clinical Emergency Hospital of Constanta Coordinator of this site? Confirm its status | Constanța | Romania | Unknown status |
| Emergency County Hospital Targu Mures Coordinator of this site? Confirm its status | Târgu Mureş | Romania | Unknown status |
| Timiş County Emergency Clinical Hospital- Neurology 1 Coordinator of this site? Confirm its status | Timișoara | Romania | Unknown status |
| Timiş County Emergency Clinical Hospital Coordinator of this site? Confirm its status | Timișoara | Romania | Unknown status |
| Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Skånes Universitetssjukhus Lund Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Unknown status |
| Department of Neurology, University Medical Centre Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
| Univerzitetni klinični center Maribor Coordinator of this site? Confirm its status | Maribor | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.