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

NCT05043103 | Active Not Recruiting

• 1 other identifier: NIS-MA-2020-02
• Study Type: observational
• Target: 312
• Locations: 14 countries
• Sites: 57

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.

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

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (5)

• Change in Non-Motor Symptoms from baseline up to 24 months, or treatment or study discontinuation

  24 months

• Change in Sleep Quality from baseline up to 24 months, or treatment or study Discontinuation

  24 months

• Change in Activities of daily living from baseline up to 24 months, or treatment or study discontinuation

  24 months

• Change in Quality of Life from baseline up to 24 months or treatment or study discontinuation

  24 months

• Usage of Healthcare resources from baseline up to 24 months, or treatment or study discontinuation

  24 months

Other Outcomes (7)

• Change in Body weight 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

  24 months

• Change in Pulse from baseline up to 24 months, or treatment or study discontinuation

  24 months

Interventions

Lecigon® based on European Medicines Agency (EMA) SmPC COMBINATION_PRODUCT

There might be different brand names in other countries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Treating physician's normal patient pool

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Britannia Pharmaceuticals Ltd.: lead

Study Sites (57)

Universitätsklinik für Neurologie, Medizinische Universität Graz

Graz, 8036, Austria

Location

Abteilung für Neurologische Rehabilitation, Gailtal-Klinik

Hermagor, 9620, Austria

Location

Universitätsklinik für Neurologie, Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

Kepler Universitätsklinikum

Linz, 4020, Austria

Location

AZ Sint-Jan

Bruges, 8000, Belgium

Location

Antwerp University Hospital

Edegem, 2650, Belgium

Location

Ghent University Hospital

Ghent, Belgium

Location

University Hospital Liege

Liège, Belgium

Location

Centre Hospitalier de Wallonie picarde (Chwapi)

Tournai, 7500, Belgium

Location

Sveti Naum

Sofia, 1113, Bulgaria

Location

UHC Osijek, J. Klinici za neurologiju

Osijek, 31000, Croatia

Location

University Hospital Centre Rijeka (KBC Rijeka)

Rijeka, Croatia

Location

Klinička bolnica Dubrava

Zagreb, 10000, Croatia

Location

University Hospital Centre (KBC Zagreb)

Zagreb, 10000, Croatia

Location

Masaryk university

Brno, Czechia

Location

Fakultní nemocnice Olomouc

Olomouc, Czechia

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Segeberger Kliniken GmbH Neurologisches Zentrum

Bad Segeberg, 23795, Germany

Location

Kliniken Beelitz GmbH Neurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson

Beelitz-Heilstätten, 14547, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Uniklinik Köln

Cologne, Germany

Location

Krankenhaus Lindenbrunn

Coppenbrügge, 31863, Germany

Location

Klinik für Neurologie - Universitätsklinikum Essen

Essen, 45147, Germany

Location

Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

Freiburg im Breisgau, 79106, Germany

Location

Zentrum für Seltene Erkrankungen Göttingen

Göttingen, 37075, Germany

Location

Universitätsklinikum Giessen und Marburg

Marburg, 35043, Germany

Location

Evangelisches Krankenhaus Oldenburg

Oldenburg, 26122, Germany

Location

Klinikum Osnabrück GmbH Klinik für Neurologie

Osnabrück, 49076, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

RKU - Universitäts und Rehabilitationskliniken Ulm gGmbH

Ulm, 89081, Germany

Location

Parkinson-Klinik Ortenau

Wolfach, 77709, Germany

Location

Semmelweis Egyetem Neurológiai Klinika Budapest

Budapest, Hungary

Location

Pécsi Tudományegyetem Klinikai Központ Szemészeti Klinika

Pécs, 7623, Hungary

Location

SZTE Szent-Györgyi Albert Klinikai Közpon

Szeged, 6725, Hungary

Location

St. Vincent's University Hospital

Dublin, D04 T6F4, Ireland

Location

The Dublin Neurological Institute, Mater Hospital

Dublin, D07 R2WY, Ireland

Location

University Medical Center Groningen

Groningen, 97139713, Netherlands

Location

Emergency Hospital Brasov, Spitalul Clinic Județean de Urgență Brașov

Brasov, 500326, Romania

Location

Spitalul Universitar de Urgență Elias

Bucharest, 011461, Romania

Location

Colentina Hospital Bucharest

Bucharest, 020125, Romania

Location

Bucharest University Emergency Hospital

Bucharest, 050098, Romania

Location

Fundeni Clinical Institute

Bucharest, Romania

Location

County Emergency Hospital Cluj-Napoca

Cluj-Napoca, 400347, Romania

Location

County Clinical Emergency Hospital of Constanta

Constanța, 900591, Romania

Location

Emergency County Hospital Targu Mures

Târgu Mureş, 540136, Romania

Location

Timiş County Emergency Clinical Hospital- Neurology 1

Timișoara, 300723, Romania

Location

Timiş County Emergency Clinical Hospital

Timișoara, 300723, Romania

Location

Department of Neurology, University Medical Centre

Ljubljana, 1000, Slovenia

Location

Univerzitetni klinični center Maribor

Maribor, 2000, Slovenia

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital de la Princesa

Madrid, Spain

Location

Hospital Virgen del Rocio

Seville, 41013, Spain

Location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Skånes universitetssjukhus Lund

Lund, Sweden

Location

Uppsala university hospital

Uppsala, 751 85, Sweden

Location

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: September 14, 2021
• Study Start: July 6, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-01

Locations

CR (4); SE (3); SL (2); ES (5); BE (5); CZ (2); HU (3); DE (14); AU (4); RO (10); IE (2); DK (1); NL (1); BU (1)