Project description DEENESFRITPL Parkinson’s disease modifying strategy using iron chelation Parkinson’s disease (PD) is the second most prevalent neurodegenerative disorder. It is associated with iron excess in the substantia nigra, exposing dopaminergic neurons to high levels of oxidative stress resulting from mitochondrial and dopamine metabolism disorders. Previous preclinical and pilot clinical studies demonstrated the effectiveness of a novel iron chelation therapy with deferiprone (DFP) in inducing neuroprotection in PD cell models, as well as slowing the disease progression in mouse models and early-stage PD patients. The objective of the EU-funded FAIR-PARK-II project is to conduct a parallel-group, randomised, placebo-controlled, clinical trial to demonstrate that DFP can slow the progression of disability in de novo PD patients, thereby establishing iron chelation as a disease-modifying treatment in neurodegeneration. Show the project objective Hide the project objective Objective 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) (i) induces neuroprotection in cell models of PD via a powerful antioxidant effect, (ii) reduces regional siderosis of the brain, (iii) reduces motor handicap via inhibition of catechol-o-methyl transferase, and (iv) slows the progression of motor handicap in the 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine mouse model and in early PD patients. 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. 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 be assessed. 17 national, European and international research and innovation activities will be linked with the project. The study results should prompt academic and industrial research on iron chelation as a disease-modifying treatment in neurodegenerative diseases. Fields of science natural sciencescomputer and information sciencesdatabasesengineering and technologyelectrical engineering, electronic engineering, information engineeringelectronic engineeringsensorsmedical and health sciencesbasic medicineneurologyparkinsonsocial scienceseconomics and businesseconomicshealth economicsnatural sciencesphysical sciencesacousticsultrasound Keywords Neuroprotection disease modifier iron chelation oxidative stress clinical trial Parkinson’s disease Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Topic(s) PHC-13-2014 - New therapies for chronic non-communicable diseases Call for proposal H2020-PHC-2014-2015 See other projects for this call Sub call H2020-PHC-2014-two-stage Funding Scheme RIA - Research and Innovation action Coordinator CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE LILLE Net EU contribution € 2 604 799,55 Address Avenue oscar lambret 2 59037 Lille France See on map Region Hauts-de-France Nord-Pas de Calais Nord Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 2 604 799,55 Participants (20) Sort alphabetically Sort by Net EU contribution Expand all Collapse all INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE France Net EU contribution € 642 888,00 Address Rue de tolbiac 101 75654 Paris See on map Region Ile-de-France Ile-de-France Paris Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 642 888,00 ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK France Net EU contribution € 331 848,00 Address 30 bd saint-jacques batiment b 75014 Paris See on map Region Ile-de-France Ile-de-France Paris Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 331 848,00 INSERM TRANSFERT SA France Net EU contribution € 389 491,00 Address 10 rue d'oradour-sur-glane - parisante campus 75015 Paris See on map Region Ile-de-France Ile-de-France Paris Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 389 491,00 APO-PHARMA INC CORP Participation ended Canada Net EU contribution € 0,00 Address Signet drive 150 M9L 1T9 Toronto See on map Activity type Other Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 2 256 411,50 INSTITUTO DE MEDICINA MOLECULAR JOAO LOBO ANTUNES Portugal Net EU contribution € 187 083,00 Address Avenida prof egas moniz 1649 028 Lisboa See on map Region Continente Área Metropolitana de Lisboa Área Metropolitana de Lisboa Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 187 083,00 FUNDACIO DE RECERCA CLINIC BARCELONA-INSTITUT D INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER Spain Net EU contribution € 183 672,00 Address Carrer rossello 149 08036 Barcelona See on map Region Este Cataluña Barcelona Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 196 773,25 Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. HOSPITAL CLINIC DE BARCELONA Spain Net EU contribution € 13 101,25 Address Calle villarroel 170 08036 Barcelona See on map Region Este Cataluña Barcelona Activity type Research Organisations Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 13 101,25 UNIVERSITY OF NEWCASTLE UPON TYNE United Kingdom Net EU contribution € 313 370,00 Address Kings gate NE1 7RU Newcastle upon tyne See on map Region North East (England) Northumberland and Tyne and Wear Tyneside Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 313 370,00 EBERHARD KARLS UNIVERSITAET TUEBINGEN Participation ended Germany Net EU contribution € 48 078,38 Address Geschwister-scholl-platz 72074 Tuebingen See on map Region Baden-Württemberg Tübingen Tübingen, Landkreis Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 48 078,38 MEDIZINISCHE UNIVERSITAT INNSBRUCK Austria Net EU contribution € 226 735,00 Address Christoph probst platz 1 6020 Innsbruck See on map Region Westösterreich Tirol Innsbruck Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 226 735,00 UNIVERZITA KARLOVA Czechia Net EU contribution € 145 000,00 Address Ovocny trh 560/5 116 36 Praha 1 See on map Region Česko Praha Hlavní město Praha Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 145 000,00 STICHTING RADBOUD UNIVERSITEIT Participation ended Netherlands Net EU contribution € 0,00 Address Houtlaan 4 6525 XZ Nijmegen See on map Region Oost-Nederland Gelderland Arnhem/Nijmegen Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost No data PHILIPPS UNIVERSITAET MARBURG Germany Net EU contribution € 74 875,00 Address Biegenstrasse 10 35037 Marburg See on map Region Hessen Gießen Marburg-Biedenkopf Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 74 875,00 SORBONNE UNIVERSITE France Net EU contribution € 82 550,00 Address 21 rue de l'ecole de medecine 75006 Paris See on map Region Ile-de-France Ile-de-France Paris Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 82 550,00 UNIVERSITAET ULM Germany Net EU contribution € 90 000,00 Address Helmholtzstrasse 16 89081 Ulm See on map Region Baden-Württemberg Tübingen Ulm, Stadtkreis Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 90 000,00 CHRISTIAN-ALBRECHTS-UNIVERSITAET ZU KIEL Participation ended Germany Net EU contribution € 378 071,50 Address Olshausenstrasse 40 24118 Kiel See on map Region Schleswig-Holstein Schleswig-Holstein Kiel, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 378 071,50 UNIVERSITATSKLINIKUM SCHLESWIG-HOLSTEIN Germany Net EU contribution € 31 181,32 Address Ratzeburger allee 160 23562 Lübeck See on map Region Schleswig-Holstein Schleswig-Holstein Lübeck, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 31 181,32 Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. CHRISTIAN-ALBRECHTS-UNIVERSITAET ZU KIEL Germany Net EU contribution € 0,00 Address Olshausenstrasse 40 24118 Kiel See on map Region Schleswig-Holstein Schleswig-Holstein Kiel, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost No data STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM Netherlands Net EU contribution € 256 250,00 Address Geert grooteplein 10 zuid 6525 GA Nijmegen See on map Region Oost-Nederland Gelderland Arnhem/Nijmegen Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 256 250,00 CHIESI FARMACEUTICI SPA Italy Net EU contribution € 0,00 Address Via palermo 26/a 43122 Parma See on map Region Nord-Est Emilia-Romagna Parma Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 7 797,00