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

Last updated: October 2, 2024
Sponsor: Britannia Pharmaceuticals Ltd.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Lecigon® based on European Medicines Agency (EMA) SmPC

Clinical Study ID

NCT05043103
NIS-MA-2020-02
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult Patients (18 years old and over) with Advanced Parkinson Disease already undertreatment with Lecigon® (for up to 3 months before giving informed consent) inaccordance with the Summary of Product Characteristics (SmPC)

  • Patients or legal representative must have signed informed consent to participate inthe study

  • Patients are not taking part in another clinical (interventional) study at the sametime

Exclusion

Exclusion Criteria:

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

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

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

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Lecigon® based on European Medicines Agency (EMA) SmPC
Phase:
Study Start date:
July 06, 2021
Estimated Completion Date:
September 30, 2026

Study 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

Connect with a study center

  • Universitätsklinik für Neurologie, Medizinische Universität Graz

    Graz, 8036
    Austria

    Site Not Available

  • Abteilung für Neurologische Rehabilitation, Gailtal-Klinik

    Hermagor, 9620
    Austria

    Site Not Available

  • Universitätsklinik für Neurologie, Medizinische Universität Innsbruck

    Innsbruck, 6020
    Austria

    Site Not Available

  • Kepler Universitätsklinikum

    Linz, 4020
    Austria

    Site Not Available

  • AZ Sint-Jan

    Brugge, 8000
    Belgium

    Site Not Available

  • Antwerp University Hospital

    Edegem, 2650
    Belgium

    Site Not Available

  • Ghent University Hospital

    Ghent,
    Belgium

    Site Not Available

  • University Hospital Liege

    Liège,
    Belgium

    Site Not Available

  • Centre Hospitalier de Wallonie picarde (Chwapi)

    Tournai, 7500
    Belgium

    Site Not Available

  • Sveti Naum

    Sofia, 1113
    Bulgaria

    Site Not Available

  • UHC Osijek, J. Klinici za neurologiju

    Osijek, 31000
    Croatia

    Site Not Available

  • University Hospital Centre Rijeka (KBC Rijeka)

    Rijeka,
    Croatia

    Site Not Available

  • Klinička bolnica Dubrava

    Zagreb, 10000
    Croatia

    Site Not Available

  • University Hospital Centre (KBC Zagreb)

    Zagreb, 10000
    Croatia

    Site Not Available

  • Masaryk university

    Brno,
    Czechia

    Site Not Available

  • Fakultní nemocnice Olomouc

    Olomouc,
    Czechia

    Site Not Available

  • Bispebjerg Hospital

    København, 2400
    Denmark

    Site Not Available

  • Segeberger Kliniken GmbH Neurologisches Zentrum

    Bad Segeberg, 23795
    Germany

    Site Not Available

  • Kliniken Beelitz GmbH Neurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson

    Beelitz-Heilstätten, 14547
    Germany

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Uniklinik Köln

    Cologne,
    Germany

    Site Not Available

  • Krankenhaus Lindenbrunn

    Coppenbrügge, 31863
    Germany

    Site Not Available

  • Klinik für Neurologie - Universitätsklinikum Essen

    Essen, 45147
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

    Freiburg, 79106
    Germany

    Site Not Available

  • Zentrum für Seltene Erkrankungen Göttingen

    Göttingen, 37075
    Germany

    Site Not Available

  • Universitätsklinikum Giessen und Marburg

    Marburg, 35043
    Germany

    Site Not Available

  • Evangelisches Krankenhaus Oldenburg

    Oldenburg, 26122
    Germany

    Site Not Available

  • Klinikum Osnabrück GmbH Klinik für Neurologie

    Osnabrück, 49076
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • RKU - Universitäts und Rehabilitationskliniken Ulm gGmbH

    Ulm, 89081
    Germany

    Site Not Available

  • Parkinson-Klinik Ortenau

    Wolfach, 77709
    Germany

    Site Not Available

  • Semmelweis Egyetem Neurológiai Klinika Budapest

    Budapest,
    Hungary

    Site Not Available

  • Pécsi Tudományegyetem Klinikai Központ Szemészeti Klinika

    Pécs, 7623
    Hungary

    Site Not Available

  • SZTE Szent-Györgyi Albert Klinikai Közpon

    Szeged, 6725
    Hungary

    Site Not Available

  • St. Vincent's University Hospital

    Dublin, D04 T6F4
    Ireland

    Site Not Available

  • The Dublin Neurological Institute, Mater Hospital

    Dublin, D07 R2WY
    Ireland

    Site Not Available

  • University Medical Center Groningen

    Groningen, 97139713
    Netherlands

    Site Not Available

  • Emergency Hospital Brasov, Spitalul Clinic Județean de Urgență Brașov

    Braşov, 500326
    Romania

    Site Not Available

  • Spitalul Universitar de Urgență Elias

    Bucharest, 011461
    Romania

    Site Not Available

  • Bucharest University Emergency Hospital

    București, 050098
    Romania

    Site Not Available

  • Colentina Hospital Bucharest

    București, 020125
    Romania

    Site Not Available

  • Fundeni Clinical Institute

    București,,
    Romania

    Site Not Available

  • County Emergency Hospital Cluj-Napoca

    Cluj-Napoca, 400347
    Romania

    Site Not Available

  • County Clinical Emergency Hospital of Constanta

    Constanța, 900591
    Romania

    Site Not Available

  • Timiş County Emergency Clinical Hospital

    Timișoara, 300723
    Romania

    Site Not Available

  • Timiş County Emergency Clinical Hospital- Neurology 1

    Timișoara, 300723
    Romania

    Site Not Available

  • Emergency County Hospital Targu Mures

    Târgu-Mureş, 540136
    Romania

    Site Not Available

  • Department of Neurology, University Medical Centre

    Ljubljana, 1000
    Slovenia

    Site Not Available

  • Univerzitetni klinični center Maribor

    Maribor, 2000
    Slovenia

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Site Not Available

  • Hospital Clínico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital de la Princesa

    Madrid,
    Spain

    Site Not Available

  • Hospital Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Sahlgrenska University Hospital

    Gothenburg, 413 45
    Sweden

    Site Not Available

  • Skånes universitetssjukhus Lund

    Lund,
    Sweden

    Site Not Available

  • Uppsala university hospital

    Uppsala, 751 85
    Sweden

    Site Not Available

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