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CORDIS

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

Fact Sheet

Reporting

Results

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.

Programme(s)

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-two-stage

See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Leaflet | Map data © OpenStreetMap contributors, Credit: EC-GISCO, © EuroGeographics for the administrative boundaries

Coordinator

CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE LILLE

Address

Avenue Oscar Lambret 2
59037 Lille

France

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 2 662 169,75

Website

Contact the organisation

Participants (16)

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INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

France

EU Contribution

€ 642 888

ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK

France

EU Contribution

€ 331 848

INSERM TRANSFERT SA

France

EU Contribution

€ 389 491

APO-PHARMA INC CORP

Canada

INSTITUTO DE MEDICINA MOLECULAR JOAO LOBO ANTUNES

Portugal

EU Contribution

€ 187 083

FUNDACIO CLINIC PER A LA RECERCA BIOMEDICA

Spain

EU Contribution

€ 196 773,25

UNIVERSITY OF NEWCASTLE UPON TYNE

United Kingdom

EU Contribution

€ 313 370

EBERHARD KARLS UNIVERSITAET TUEBINGEN

Germany

EU Contribution

€ 48 078,38

MEDIZINISCHE UNIVERSITAT INNSBRUCK

Austria

EU Contribution

€ 226 735

UNIVERZITA KARLOVA

Czechia

EU Contribution

€ 145 000

STICHTING KATHOLIEKE UNIVERSITEIT

Netherlands

EU Contribution

€ 256 250

PHILIPPS UNIVERSITAET MARBURG

Germany

EU Contribution

€ 74 875

UNIVERSITE PIERRE ET MARIE CURIE - PARIS 6

France

SORBONNE UNIVERSITE

France

EU Contribution

€ 82 550

UNIVERSITAET ULM

Germany

EU Contribution

€ 90 000

CHRISTIAN-ALBRECHTS-UNIVERSITAET ZU KIEL

Germany

EU Contribution

€ 351 882,62

Project information

FAIR-PARK-II

Grant agreement ID: 633190

Project website

Status

Ongoing project

Start date

1 May 2015
End date

30 April 2020

Funded under:

H2020-EU.3.1.3.

Overall budget:

€ 8 263 202,50
EU contribution

€ 5 998 994

Coordinated by:

CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE LILLE

France

Periodic Reporting for period 1 - FAIR-PARK-II (Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease: a multicentric, parallel-group, placebo-controlled, randomized clinical trial of deferiprone)

Reporting period: 2015-05-01 to 2016-10-31

Summary of the context and overall objectives of the project

Parkinson’s disease (PD) the 2nd most frequent neurodegenerative disorder worldwide. Excess iron is 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 pilot clinical studies demonstrated that novel iron chelation therapy with the prototypic drug deferiprone (DFP) (i) induces neuroprotection in cell models of PD, (ii) reduces regional siderosis of the brain, (iii) reduces motor and (iv) slows the progression of motor handicap. This project now seeks to demonstrate that DFP slows the progression of handicap in de novo PD patients while not affecting systemic parameters. The primary efficacy criterion will be the change in motor and non motor handicap scores on the Total MDS-UPDRS to identify disease-modifying and symptomatic effects. Potential surrogate radiological and biological biomarkers, health economics and societal impacts will be assessed.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

logo-fair-park-vd-72.jpg

Project information

FAIR-PARK-II

Grant agreement ID: 633190

Project website

Status

Ongoing project

Start date

1 May 2015
End date

30 April 2020

Funded under:

H2020-EU.3.1.3.

Overall budget:

€ 8 263 202,50
EU contribution

€ 5 998 994

Coordinated by:

CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE LILLE

Deliverables

Websites, patent fillings, videos etc. (1)

Communication and Dissemination tools including website

Graphic standards (M1), presentation leaflet and poster (M3), FAIR-PARK-II PowerPoint presentation (M3), provisional public website goes live (M1), FAIR-PARK-II website fully functional, including the secure area (M4), and a press release at the time of the kick-off meeting (M1)

Publications

Peer reviewed articles (3)

New perspectives on study designs for evaluating neuroprotection in Parkinson's disease

Author(s): Laetitia Thibault, Olivier Rascol, Jean-Christophe Corvol, Joaquim Ferreira, Luc Defebvre, Dominique Deplanque, Régis Bordet, Caroline Moreau, David Devos

Published in: Movement Disorders, Issue 32/10, 2017, Page(s) 1365-1370, ISSN 0885-3185

DOI: 10.1002/mds.27055

Characterization of active and infiltrative tumorous subregions from normal tissue in brain gliomas using multiparametric MRI

Author(s): Anahita Fathi Kazerooni, Mahnaz Nabil, Mehdi Zeinali Zadeh, Kavous Firouznia, Farid Azmoudeh-Ardalan, Alejandro F. Frangi, Christos Davatzikos, Hamidreza Saligheh Rad

Published in: Journal of Magnetic Resonance Imaging, 2017, ISSN 1053-1807

DOI: 10.1002/jmri.25963

Iron as a therapeutic target for Parkinson's disease

Author(s): Caroline Moreau, James A. Duce, Olivier Rascol, Jean-Christophe Devedjian, Daniela Berg, David Dexter, Z. Ioav Cabantchik, Ashley I. Bush, David Devos

Published in: Movement Disorders, Issue 33/4, 2018, Page(s) 568-574, ISSN 0885-3185

DOI: 10.1002/mds.27275

Project information

FAIR-PARK-II

Grant agreement ID: 633190

Project website

Status

Ongoing project

Start date

1 May 2015
End date

30 April 2020

Funded under:

H2020-EU.3.1.3.

Overall budget:

€ 8 263 202,50
EU contribution

€ 5 998 994

Coordinated by:

CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE LILLE

Project information

FAIR-PARK-II

Grant agreement ID: 633190

Project website

Status

Ongoing project

Start date

1 May 2015
End date

30 April 2020

Funded under:

H2020-EU.3.1.3.

Overall budget:

€ 8 263 202,50
EU contribution

€ 5 998 994

Coordinated by:

CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE LILLE

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Last update: 18 May 2017

Record number: 193184

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Participants (16)

Project information

Periodic Reporting for period 1 - FAIR-PARK-II (Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease: a multicentric, parallel-group, placebo-controlled, randomized clinical trial of deferiprone)

Project information

Deliverables

Publications

Project information

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