FairPark II is a major EU-funded research project that will primarily investigate the effects of an iron chelation therapy on the progression of handicap in Parkinson's disease.
The project will run for five years (2015 - 2020) and will see 15 partners collaborate on a range of investigations including a multicentre clinical trial of the therapy in Parkinson's disease patients.
The full title of the project is: "Conservative iron chelation as a disease-modifying strategy in Parkinson's disease: a multicentric, parallel group, placebo-controlled, randomized clinical trial of deferiprone."
Parkinson’s disease (PD) is a major, chronic, non-communicable disease and the 2nd most frequent neurodegenerative disorder worldwide.
Excess iron is primarily detected in the substantia nigra pars compacta, where dopaminergic neurons are exposed to high levels of oxidative stress produced by mitochondrial disorders and dopamine metabolism.
Our previous preclinical, translational and pilot clinical studies demonstrated that novel iron chelation therapy with the prototypic drug deferiprone (DFP)
- induces neuroprotection in cell models of PD via a powerful antioxidant effect,
- reduces regional siderosis of the brain,
- reduces motor handicap via inhibition of catechol-o-methyl transferase, and
- slows the progression of motor handicap in the 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine mouse model and in early PD patients.
Clinical Trial - Aims
This project now seeks to demonstrate that conservative iron chelation therapy with moderate-dose DFP (30 mg/kg/day) slows the progression of handicap in de novo PD patients while not affecting systemic parameters. The 9-month, parallel-group, randomized, placebo-controlled, multicentre trial will be followed by a 1-month wash-out period.
Primary and Secondary Outcomes
The primary efficacy criterion will be the change in motor and non-motor handicap scores on the Total Movement Disorders Society Unified Parkinson’s Disease Rating Scale to identify disease-modifying and symptomatic effects.
The secondary efficacy criterion will be the change in score between baseline and 40 weeks (i.e. probing the disease-modifying effect only).
Potential surrogate radiological and biological biomarkers, health economics and societal impacts will also be assessed.
Who is involved?
17 national, European and international studies will be linked to the project.
The study results should prompt academic and industrial research on iron chelation and other disease-modifying treatments (which slow down disease progression) in Parkinson's disease and other neurodegenerative diseases.
- You can find out much more about our project and clinical study on this site. We have included details on the context of the project, the background studies, our project strategy and the expected outcomes.
- If you are a patient with Parkinson's disease and want to find out more about participating in the study, take a look at our dedicated patient pages.
- We have included a detailed FAQ that we hope will answer any questions you might have about the project and study.
- Want to know who we are? You can find out much more about the consortium here.
- Latest updates about the project? News and events covers all of that.
- Results? When we have them, they will be here.
- Want to contact us? Go here.