ELEGANCE - Evaluation of Lecigon in Routine Care
Research type
Research Study
Full 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
IRAS ID
316816
Contact name
K Ray Chaudhuri
Contact email
Sponsor organisation
Britannia Pharmaceuticals Ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
ClinicalTrials.gov, NCT05043103
Duration of Study in the UK
3 years, 0 months, 19 days
Research summary
The ELEGANCE study will evaluate patients who have Parkinson’s disease and who are receiving routine treatment with the medication Lecigon, in accordance with the marketing authorisation. The study will collect data about patients disease state and any side effects of the medication. The study aims to collect data, which is so called “real world data” – this provides information about what is happening in routine medical treatment, rather than inside a controlled clinical trial. The study does not require any additional visits to the hospital, or any additional tests beyond those, which would be the standard treatment for the patient, at their hospital. This kind of study is called a “non-interventional” study.
The doctors treating the patients will collect the “real-world” data over a period of 2 years for each patient. The data will be analysed by the pharmaceutical company in order to better understand how the medicine is working in a broad range of Parkinson’s disease patients.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
22/LO/0513
Date of REC Opinion
4 Oct 2022
REC opinion
Further Information Favourable Opinion