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Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease: a multicentric, parallel-group, placebo-controlled, randomized clinical trial of deferiprone

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.

Call for proposal

H2020-PHC-2014-2015

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Sub call

H2020-PHC-2014-two-stage

Coordinator

CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE LILLE
Net EU contribution
€ 2 604 799,55
Address
Avenue Oscar Lambret 2
59037 Lille
France

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Region
Hauts-de-France Nord-Pas de Calais Nord
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00

Participants (20)

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
Net EU contribution
€ 642 888,00
Address
Rue De Tolbiac 101
75654 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 0,00
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
Net EU contribution
€ 331 848,00
Address
5 Rue Watt
75013 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 0,00
INSERM TRANSFERT SA
France
Net EU contribution
€ 389 491,00
Address
Rue Watt 7
75013 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
APO-PHARMA INC CORP

Participation ended

Canada
Net EU contribution
€ 0,00
Non-EU contribution
€ 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

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Region
Continente Área Metropolitana de Lisboa Área Metropolitana de Lisboa
Activity type
Research Organisations
Non-EU contribution
€ 0,00
FUNDACIO CLINIC PER A LA RECERCA BIOMEDICA
Spain
Net EU contribution
€ 183 672,00
Address
Carrer Rossello 149
08036 Barcelona

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Region
Este Cataluña Barcelona
Activity type
Research Organisations
Non-EU contribution
€ 0,00
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

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Region
Este Cataluña Barcelona
Activity type
Research Organisations
Non-EU contribution
€ 0,00
UNIVERSITY OF NEWCASTLE UPON TYNE
United Kingdom
Net EU contribution
€ 313 370,00
Address
Kings Gate
NE1 7RU Newcastle Upon Tyne

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Region
North East (England) Northumberland and Tyne and Wear Tyneside
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
EBERHARD KARLS UNIVERSITAET TUEBINGEN

Participation ended

Germany
Net EU contribution
€ 48 078,38
Address
Geschwister-scholl-platz
72074 Tuebingen

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Region
Baden-Württemberg Tübingen Tübingen, Landkreis
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
MEDIZINISCHE UNIVERSITAT INNSBRUCK
Austria
Net EU contribution
€ 226 735,00
Address
Christoph Probst Platz 1
6020 Innsbruck

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Region
Westösterreich Tirol Innsbruck
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
UNIVERZITA KARLOVA
Czechia
Net EU contribution
€ 145 000,00
Address
Ovocny Trh 560/5
116 36 Praha 1

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Region
Praha Hlavní město Praha
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
STICHTING RADBOUD UNIVERSITEIT

Participation ended

Netherlands
Net EU contribution
€ 0,00
Address
Houtlaan 4
6525 XZ Nijmegen

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Region
Oost-Nederland Gelderland Arnhem/Nijmegen
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
PHILIPPS UNIVERSITAET MARBURG
Germany
Net EU contribution
€ 74 875,00
Address
Biegenstrasse 10
35037 Marburg

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Region
Baden-Württemberg Stuttgart Stuttgart, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
SORBONNE UNIVERSITE
France
Net EU contribution
€ 82 550,00
Address
21 Rue De L'ecole De Medecine
75006 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
UNIVERSITAET ULM
Germany
Net EU contribution
€ 90 000,00
Address
Helmholtzstrasse 16
89081 Ulm

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Region
Baden-Württemberg Tübingen Ulm, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
CHRISTIAN-ALBRECHTS-UNIVERSITAET ZU KIEL

Participation ended

Germany
Net EU contribution
€ 378 071,50
Address
Olshausenstrasse 40
24118 Kiel

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Region
Schleswig-Holstein Schleswig-Holstein Kiel, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
UNIVERSITATSKLINIKUM SCHLESWIG-HOLSTEIN
Germany
Net EU contribution
€ 31 181,32
Address
Ratzeburger Allee 160
23562 Lübeck

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Region
Baden-Württemberg Stuttgart Stuttgart, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
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

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Region
Schleswig-Holstein Schleswig-Holstein Kiel, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM
Netherlands
Net EU contribution
€ 256 250,00
Address
Geert Grooteplein 10 Zuid
6525 GA Nijmegen

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Region
Oost-Nederland Gelderland Arnhem/Nijmegen
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
CHIESI FARMACEUTICI SPA
Italy
Net EU contribution
€ 0,00
Address
Via Palermo 26/a
43122 Parma

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Region
Nord-Est Emilia-Romagna Parma
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 7 797,00