How to participate ?
The SCOL trial will recruit a total of thirty patients in the three participating countries. The LIH and the CHL are therefore currently recruiting ten volunteers with Parkinson’s disease. Anyone over the age of 30 with a confirmed diagnosis of Parkinson’s disease and responding well to levodopa can participate. Participation in the clinical trial will last for twenty-nine days. This trial is completely independent of the National Center of Excellence for Research on Parkinson’s Disease (NCER-PD) but participants in the Luxembourg Study on Parkinson’s Disease can of course participate.
At the start of the trial, participants will be hospitalized at the CHL for three days to switch from their usual treatment with levodopa tablets to treatment with DopaFuse. They will then continue treatment at home until the 14th day, before being hospitalized a second time for a day for further treatment evaluation. The safety of the device will be assessed regularly and follow-up visits will take place at home until the end of the trial. Regular control visits to the CHL are also planned for the duration of the trial. They will be carried out with the support of two LIH teams: the team « Transversal Translational Medicine » (TTM) and the team of Clinical and Epidemiological Investigation Center (CIEC). Clinical data and blood samples will be collected as part of the trial.
What is the difference between a clinical trial like SCOL and a clinical study like NCER-PD?
Clinical research is defined as all the medical research carried out on humans. It aims to improve our knowledge of different diseases and, in the long term, to improve patient care. The Luxembourg Study on Parkinson’s Disease conducted as part of NCER-PD is one of the largest clinical research studies in Luxembourg. By studying 800 Parkinson’s disease patients and 800 controls, the researchers aim to find new methods allowing earlier diagnosis and towards better treatments. It is important to note that the Luxembourg Study on Parkinson’s disease is an observational clinical study. This means that no medication is given during the study and that the patients continue to follow the treatment prescribed by their attending physician.
In contrast, clinical trials, often conducted by pharmaceutical companies in collaboration with partners in the healthcare industry or academia, are the last step in the long process of research and development that leads to a new drug. They make it possible to assess the safety and efficacy of these new potential treatments. During a clinical trial, participants will therefore change treatment and are then closely monitored for a defined period. The SCOL clinical trial is the first clinical trial on Parkinson’s disease conducted in Luxembourg. It aims to assess whether the DopaFuse system can help reduce fluctuations in the level of levodopa in the blood compared to standard treatment with levodopa tablets. The trial will also be used to assess how well participants tolerate this new mode of administration.
The link with the NCER-PD research program
As mentioned previously, the Luxembourg Study on Parkinson’s Disease is an observational clinical study. This study brings together several national and international partners with the aim of contributing to research on Parkinson’s disease in Luxembourg. The Luxembourg Institute of Health (LIH) and the Center hospitalier de Luxembourg (CHL), which have been among the partners involved in the Luxembourg Study on Parkinson’s disease since its inception, are in charge of the SCOL clinical trial in Luxembourg and will therefore bring their expertise on Parkinson’s disease to this trial.
« The SCOL study is a new example of the pioneering clinical research work carried out in Luxembourg. Indeed, thanks to our long expertise in the field of Parkinson’s disease, illustrated by initiatives such as NCER-PD, which brings together several Luxembourg research institutions, we are one of the first three countries in the world to test this new method of administration of levodopa. We are convinced that our innovative approach will allow us to generate significant results and help improve patient care. », Concludes Professor Rejko Krüger, principal investigator at the CHL clinical site in Luxembourg, director of the TTM team at LIH and coordinator of the NCER-PD program.
If you would like to participate, contact the following number: +352 44 11 8359
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