Active, not recruitingAge-related condition
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
- Sponsor
- Britannia Pharmaceuticals Ltd. (Industry)
- Enrolment
- 312 enrolled
- Conditions
- Advanced Parkinson Disease
- Interventions
- Lecigon® based on European Medicines Agency (EMA) SmPC
- Ages
- adults, older adults
- Registry
- NCT05043103
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change in OFF time from baseline up to 24 months, or treatment or study discontinuation
- Change in activities of daily living from baseline up to 24 months, or treatment or study discontinuation
- Change in Daily Levodopa dose from baseline up to 24 months, or treatment or study discontinuation
- Usage of other Anti-Parkinsonian medicinal products from baseline up to 24 months, or treatment or study discontinuation
History
Primary completion
Last registry update
Registered
Started