Lecigon® based on European Medicines Agency (EMA) SmPC
There might be different brand names in other countries
Loading study record…
Loading study record…
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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-04-23
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
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
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
There might be different brand names in other countries
Eligibility
Treating physician's normal patient pool
primary outcomes
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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 outcomes
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
other outcomes
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Publications
No exact PMID-linked public article is currently readable locally.