Clinical trial NCT05043103: Long-Term Observational Study on Effectiveness and Safety of Lecigon in Patients with Advanced Parkinson's Disease
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Advanced Parkinson Disease
Keywords: Parkinson´s Disease
Movement Disorders
Levodopa
Entacapone
Carbidopa Levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia-Agents
Dopamine Agents
Dopamine Agonists
Catechol-O-methyltransferase (COMT) inhibitor
Portable Pump
Gel
Quality of Life
Lead sponsor: Britannia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treating physician's normal patient pool

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in OFF time from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
measure: Change in activities of daily living from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
measure: Change in Daily Levodopa dose from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
measure: Usage of other Anti-Parkinsonian medicinal products from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
measure: Usage of the Lecigon® pump from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
measure: Change in Clinical Global Impression of Improvement (CGI-I) from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
measure: Change in Patient Global Impression of Change from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
measure: Satisfaction with treatment from baseline up to 24 months or treatment or study discontinuation
timeFrame: 24 months
measure: Occurrence of AEs and SAEs from baseline up to 24 months or treatment or study discontinuation
timeFrame: 24 months
Secondary outcomes:
measure: Change in Non-Motor Symptoms from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
measure: Change in Sleep Quality from baseline up to 24 months, or treatment or study Discontinuation
timeFrame: 24 months
measure: Change in Activities of daily living from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
measure: Change in Quality of Life from baseline up to 24 months or treatment or study discontinuation
timeFrame: 24 months
measure: Usage of Healthcare resources from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
Other outcomes:
measure: Change in Body weight from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
measure: Change in Blood pressure from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
measure: Change in Pulse from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
measure: Change in the Liver function tests from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
measure: Change in the full blood count from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
measure: Change in the ECG from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
measure: Change in the Renal function tests from baseline up to 24 months, or treatment or study discontinuation
timeFrame: 24 months
Locations:
city: Graz
country: Austria
facility: Universitätsklinik für Neurologie, Medizinische Universität Graz
city: Hermagor
country: Austria
facility: Abteilung für Neurologische Rehabilitation, Gailtal-Klinik
city: Innsbruck
country: Austria
facility: Universitätsklinik für Neurologie, Medizinische Universität Innsbruck
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Liège
country: Belgium
facility: University Hospital Liege
city: Tournai
country: Belgium
facility: Centre Hospitalier de Wallonie picarde (Chwapi)
city: Sofia
country: Bulgaria
facility: Sveti Naum
city: Osijek
country: Croatia
facility: UHC Osijek, J. Klinici za neurologiju
city: Rijeka
country: Croatia
facility: University Hospital Centre Rijeka (KBC Rijeka)
city: Zagreb
country: Croatia
facility: Klinička bolnica Dubrava
city: Zagreb
country: Croatia
facility: University Hospital Centre (KBC Zagreb)
city: Brno
country: Czechia
facility: Masaryk university
city: Olomouc
country: Czechia
facility: Fakultní nemocnice Olomouc
city: København
country: Denmark
facility: Bispebjerg Hospital
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH Neurologisches Zentrum
city: Beelitz-Heilstätten
country: Germany
facility: Kliniken Beelitz GmbH Neurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Cologne
country: Germany
facility: Uniklinik Köln
city: Coppenbrügge
country: Germany
facility: Krankenhaus Lindenbrunn
city: Essen
country: Germany
facility: Klinik für Neurologie - Universitätsklinikum Essen
city: Göttingen
country: Germany
facility: Zentrum für Seltene Erkrankungen Göttingen
city: Marburg
country: Germany
facility: Universitätsklinikum Giessen und Marburg
city: Oldenburg
country: Germany
facility: Evangelisches Krankenhaus Oldenburg
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück GmbH Klinik für Neurologie
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: RKU - Universitäts und Rehabilitationskliniken Ulm gGmbH
city: Wolfach
country: Germany
facility: Parkinson-Klinik Ortenau
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Neurológiai Klinika Budapest
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Központ Szemészeti Klinika
city: Szeged
country: Hungary
facility: SZTE Szent-Györgyi Albert Klinikai Közpon
city: Dublin
country: Ireland
facility: St. Vincent's University Hospital
city: Dublin
country: Ireland
facility: The Dublin Neurological Institute, Mater Hospital
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Braşov
country: Romania
facility: Emergency Hospital Brasov, Spitalul Clinic Județean de Urgență Brașov
city: Bucharest
country: Romania
facility: Spitalul Universitar de Urgență Elias
city: București,
country: Romania
facility: Fundeni Clinical Institute
city: București
country: Romania
facility: Colentina Hospital Bucharest
city: București
country: Romania
facility: Bucharest University Emergency Hospital
city: Cluj-Napoca
country: Romania
facility: County Emergency Hospital Cluj-Napoca
city: Constanța
country: Romania
facility: County Clinical Emergency Hospital of Constanta
city: Timișoara
country: Romania
facility: Timiş County Emergency Clinical Hospital- Neurology 1
city: Timișoara
country: Romania
facility: Timiş County Emergency Clinical Hospital
city: Târgu-Mureş
country: Romania
facility: Emergency County Hospital Targu Mures
city: Ljubljana
country: Slovenia
facility: Department of Neurology, University Medical Centre
city: Maribor
country: Slovenia
facility: Univerzitetni klinični center Maribor
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Lund
country: Sweden
facility: Skånes universitetssjukhus Lund
city: Uppsala
country: Sweden
facility: Uppsala university hospital
Study officials:
References: