Long-Term Observational Study on Effectiveness and Safety of Lecigon in Patients with Advanced Parkinson's Disease
- Conditions
- Advanced Parkinson Disease
- Registration Number
- NCT05043103
- Lead Sponsor
- Britannia Pharmaceuticals Ltd.
- Brief 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.
- Detailed 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in OFF time from baseline up to 24 months, or treatment or study discontinuation 24 months To assess the effectiveness of Lecigon® treatment on the change in OFF time (h/day) from baseline up to 24 months, or treatment or study discontinuation as measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale IV Scores (MDS-UPDRS IV- motor complications)
Change in activities of daily living from baseline up to 24 months, or treatment or study discontinuation 24 months To assess the effectiveness of Lecigon® treatment on the change in motor experiences of daily living from baseline up to 24 months, or treatment or study discontinuation as measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale II Scores (MDS-UPDRS II - motor experiences of daily living)
Change in Daily Levodopa dose from baseline up to 24 months, or treatment or study discontinuation 24 months To assess the effectiveness of Lecigon® treatment on the change in Daily Levodopa dose \[mg/day\] from baseline up to 24 months, or treatment or study discontinuation as measured by morning bolus, continuous flow, extra boli, oral doses
Usage of other Anti-Parkinsonian medicinal products from baseline up to 24 months, or treatment or study discontinuation 24 months To assess the effectiveness of Lecigon® treatment as measured by usage of other anti-Parkinsonian medicinal products (e.g. levodopa, dopamine agonists, Monoamine Oxidase (MAO)-B inhibitors, amantadine from baseline up to 24 months, or treatment or study discontinuation
Usage of the Lecigon® pump from baseline up to 24 months, or treatment or study discontinuation 24 months To assess the effectiveness of Lecigon® treatment use of programmed pump rate (2 or 3 rates) from baseline up to 24 months, or treatment or study discontinuation will be collected
Change in Clinical Global Impression of Improvement (CGI-I) from baseline up to 24 months, or treatment or study discontinuation 24 months To assess the effectiveness of Lecigon® treatment on the change in Clinical Global Impression of Improvement (CGI-I) from baseline up to 24 months, or treatment or study discontinuation as measured by Clinical Global Impression of Improvement Scale Score (CGI-I)
Satisfaction with treatment from baseline up to 24 months or treatment or study discontinuation 24 months To assess the effectiveness with Lecigon®, satisfaction with treatment will be assessed in terms of pump size, weight, noise, handling and overall pump satisfaction from baseline up to 24 months or treatment or study discontinuation as measured by device satisfaction scale score between 0 (absolutely unsatisfied) to 10 (absolutely satisfied) for each item.
Change in Patient Global Impression of Change from baseline up to 24 months, or treatment or study discontinuation 24 months To assess the effectiveness of Lecigon® treatment on the change in Patient Global Impression of Change (PGI-C) from baseline up to 24 months, or treatment or study discontinuation as measured by Patient Global Impression of Change Scale Score (PGI-C)
Occurrence of AEs and SAEs from baseline up to 24 months or treatment or study discontinuation 24 months To assess the long-term safety of Lecigon® treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) (including drug-related, device- and procedure-related Adverse Drug Reactions (ADRs) and Serious Adverse Drug Reactions (SADRs), AEs of special interest) from time of Informed consent to study completion for up to 24 months or treatment or study discontinuation will be collected
- Secondary Outcome Measures
Name Time Method Change in Non-Motor Symptoms from baseline up to 24 months, or treatment or study discontinuation 24 months To assess the impact of Lecigon® treatment on the change in Non-Motor Symptoms from baseline up to 24 months, or treatment or study discontinuation as measured by Non-Motor Symptom Scale Scores (NMSS)
Change in Sleep Quality from baseline up to 24 months, or treatment or study Discontinuation 24 months To assess the impact of Lecigon® treatment on the change in sleep quality from baseline up to 24 months, or treatment or study discontinuation as measured by Parkinson's disease sleep Scale-2 Score (PDSS-2)
Change in Activities of daily living from baseline up to 24 months, or treatment or study discontinuation 24 months To assess the impact of Lecigon® treatment on the change in activities of daily living from baseline up to 24 months, or treatment or study discontinuation as measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale Ib Score (MDS-UPDRS Ib - non-motor experiences of daily living)
Change in Quality of Life from baseline up to 24 months or treatment or study discontinuation 24 months To assess the impact of Lecigon® treatment on the change in quality of life from baseline up to 24 months, or treatment or study discontinuation as measured by Parkinson's Disease Questionnaire total score (PDQ-8 or PDQ-39)
Usage of Healthcare resources from baseline up to 24 months, or treatment or study discontinuation 24 months To assess the impact of Lecigon® treatment on usage of Healthcare resources as measured by additional hospitalisation due to complications out of scope of nurse support team since the last visit
Trial Locations
- 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
🇧🇪Brugge, 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
🇩🇰København, 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
🇷🇴Braşov, Romania
Spitalul Universitar de Urgență Elias
🇷🇴Bucharest, Romania
Fundeni Clinical Institute
🇷🇴București,, Romania
Colentina Hospital Bucharest
🇷🇴București, Romania
Bucharest University Emergency Hospital
🇷🇴București, Romania
County Emergency Hospital Cluj-Napoca
🇷🇴Cluj-Napoca, Romania
County Clinical Emergency Hospital of Constanta
🇷🇴Constanța, Romania
Timiş County Emergency Clinical Hospital- Neurology 1
🇷🇴Timișoara, Romania
Timiş County Emergency Clinical Hospital
🇷🇴Timișoara, Romania
Emergency County Hospital Targu Mures
🇷🇴Târgu-Mureş, 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
🇪🇸Sevilla, Spain
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Skånes universitetssjukhus Lund
🇸🇪Lund, Sweden
Uppsala university hospital
🇸🇪Uppsala, Sweden