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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Parkinson Disease
• Intervention / Treatment: Combination product: Lecigon® based on European Medicines Agency (EMA) SmPC

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

• Study Type: Observational
• Enrollment (Actual): 312

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Universitätsklinik für Neurologie, Medizinische Universität Graz
  • Hermagor, Austria, 9620
    • Abteilung für Neurologische Rehabilitation, Gailtal-Klinik
  • Innsbruck, Austria, 6020
    • Universitätsklinik für Neurologie, Medizinische Universität Innsbruck
  • Linz, Austria, 4020
    • Kepler Universitätsklinikum
• Belgium
  • Bruges, Belgium, 8000
    • AZ Sint-Jan
  • Edegem, Belgium, 2650
    • Antwerp University Hospital
  • Ghent, Belgium
    • Ghent University Hospital
  • Liège, Belgium
    • University Hospital Liege
  • Tournai, Belgium, 7500
    • Centre Hospitalier de Wallonie picarde (Chwapi)
• Bulgaria
  • Sofia, Bulgaria, 1113
    • Sveti Naum
• Croatia
  • Osijek, Croatia, 31000
    • UHC Osijek, J. Klinici za neurologiju
  • Rijeka, Croatia
    • University Hospital Centre Rijeka (KBC Rijeka)
  • Zagreb, Croatia, 10000
    • Klinicka bolnica Dubrava
  • Zagreb, Croatia, 10000
    • University Hospital Centre (KBC Zagreb)
• Czechia
  • Brno, Czechia
    • Masaryk university
  • Olomouc, Czechia
    • Fakultni Nemocnice Olomouc
• Denmark
  • Copenhagen, Denmark, 2400
    • Bispebjerg Hospital
• Germany
  • Bad Segeberg, Germany, 23795
    • Segeberger Kliniken GmbH Neurologisches Zentrum
  • Beelitz-Heilstätten, Germany, 14547
    • Kliniken Beelitz GmbH Neurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson
  • Berlin, Germany, 10117
    • Charite - Universitatsmedizin Berlin
  • Cologne, Germany
    • Uniklinik Koln
  • Coppenbrügge, Germany, 31863
    • Krankenhaus Lindenbrunn
  • Essen, Germany, 45147
    • Klinik für Neurologie - Universitätsklinikum Essen
  • Freiburg im Breisgau, Germany, 79106
    • Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
  • Göttingen, Germany, 37075
    • Zentrum für Seltene Erkrankungen Göttingen
  • Marburg, Germany, 35043
    • Universitätsklinikum Giessen und Marburg
  • Oldenburg, Germany, 26122
    • Evangelisches Krankenhaus Oldenburg
  • Osnabrück, Germany, 49076
    • Klinikum Osnabrück GmbH Klinik für Neurologie
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
  • Ulm, Germany, 89081
    • RKU - Universitäts und Rehabilitationskliniken Ulm gGmbH
  • Wolfach, Germany, 77709
    • Parkinson-Klinik Ortenau
• Hungary
  • Budapest, Hungary
    • Semmelweis Egyetem Neurológiai Klinika Budapest
  • Pécs, Hungary, 7623
    • Pécsi Tudományegyetem Klinikai Központ Szemészeti Klinika
  • Szeged, Hungary, 6725
    • SZTE Szent-Györgyi Albert Klinikai Közpon
• Ireland
  • Dublin, Ireland, D04 T6F4
    • St. Vincent's University Hospital
  • Dublin, Ireland, D07 R2WY
    • The Dublin Neurological Institute, Mater Hospital
• Netherlands
  • Groningen, Netherlands, 97139713
    • University Medical Center Groningen
• Romania
  • Brasov, Romania, 500326
    • Emergency Hospital Brasov, Spitalul Clinic Județean de Urgență Brașov
  • Bucharest, Romania, 050098
    • Bucharest University Emergency Hospital
  • Bucharest, Romania
    • Fundeni Clinical Institute
  • Bucharest, Romania, 011461
    • Spitalul Universitar de Urgenta Elias
  • Bucharest, Romania, 020125
    • Colentina Hospital Bucharest
  • Cluj-Napoca, Romania, 400347
    • County Emergency Hospital Cluj-Napoca
  • Constanța, Romania, 900591
    • County Clinical Emergency Hospital of Constanta
  • Timișoara, Romania, 300723
    • Timiş County Emergency Clinical Hospital- Neurology 1
  • Timișoara, Romania, 300723
    • Timiş County Emergency Clinical Hospital
  • Târgu Mureş, Romania, 540136
    • Emergency County Hospital Targu Mures
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Department of Neurology, University Medical Centre
  • Maribor, Slovenia, 2000
    • Univerzitetni Klinicni Center Maribor
• Spain
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • Hospital de la Princesa
  • Seville, Spain, 41013
    • Hospital Virgen del Rocío
• Sweden
  • Gothenburg, Sweden, 413 45
    • Sahlgrenska University Hospital
  • Lund, Sweden
    • Skånes Universitetssjukhus Lund
  • Uppsala, Sweden, 751 85
    • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Treating physician's normal patient pool

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in OFF time from baseline up to 24 months, or treatment or study discontinuation	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)	24 months
Change in activities of daily living from baseline up to 24 months, or treatment or study discontinuation	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)	24 months
Change in Daily Levodopa dose from baseline up to 24 months, or treatment or study discontinuation	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	24 months
Usage of other Anti-Parkinsonian medicinal products from baseline up to 24 months, or treatment or study discontinuation	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	24 months
Usage of the Lecigon® pump from baseline up to 24 months, or treatment or study discontinuation	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	24 months
Change in Clinical Global Impression of Improvement (CGI-I) from baseline up to 24 months, or treatment or study discontinuation	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)	24 months
Change in Patient Global Impression of Change from baseline up to 24 months, or treatment or study discontinuation	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)	24 months
Satisfaction with treatment from baseline up to 24 months or treatment or study discontinuation	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.	24 months
Occurrence of AEs and SAEs from baseline up to 24 months or treatment or study discontinuation	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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Non-Motor Symptoms from baseline up to 24 months, or treatment or study discontinuation	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)	24 months
Change in Sleep Quality from baseline up to 24 months, or treatment or study Discontinuation	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)	24 months
Change in Activities of daily living from baseline up to 24 months, or treatment or study discontinuation	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)	24 months
Change in Quality of Life from baseline up to 24 months or treatment or study discontinuation	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)	24 months
Usage of Healthcare resources from baseline up to 24 months, or treatment or study discontinuation	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	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body weight from baseline up to 24 months, or treatment or study discontinuation	To assess the impact of Lecigon® treatment on vital signs as measured by change in the Body weight (Kg) from baseline up to 24 months, or treatment or study discontinuation	24 months
Change in Blood pressure from baseline up to 24 months, or treatment or study discontinuation	To assess the impact of Lecigon® treatment on vital signs as measured by change in the Blood pressure (mmHg) from baseline up to 24 months, or treatment or study discontinuation	24 months
Change in Pulse from baseline up to 24 months, or treatment or study discontinuation	To assess the impact of Lecigon® treatment on vital signs as measured by change in the Pulse (bpm) from baseline up to 24 months, or treatment or study discontinuation	24 months
Change in the Liver function tests from baseline up to 24 months, or treatment or study discontinuation	To assess the impact of Lecigon® treatment on laboratory results as measured by change in the Liver function tests from baseline up to 24 months or treatment or study discontinuation	24 months
Change in the full blood count from baseline up to 24 months, or treatment or study discontinuation	To assess the impact of Lecigon® treatment on laboratory results as measured by change in the full blood count including B12 metabolism panel from baseline up to 24 months or treatment or study discontinuation	24 months
Change in the ECG from baseline up to 24 months, or treatment or study discontinuation	To assess the impact of Lecigon® treatment on laboratory results as measured by change in the ECG from baseline up to 24 months or treatment or study discontinuation	24 months
Change in the Renal function tests from baseline up to 24 months, or treatment or study discontinuation	To assess the impact of Lecigon® treatment on laboratory results as measured by change in the Renal function tests from baseline up to 24 months or treatment or study discontinuation	24 months

Collaborators and Investigators

• Sponsor: Britannia Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Movement Disorders; Levodopa; Dopamine Agents; Parkinson´s Disease; Gel; Dopamine Agonists; Entacapone; Carbidopa Levodopa drug combination; Antiparkinson Agents; Anti-Dyskinesia-Agents; Catechol-O-methyltransferase (COMT) inhibitor; Portable Pump
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Parkinson Disease
• Other Study ID Numbers: NIS-MA-2020-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No