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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

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.
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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

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

Grant agreement ID: 633190

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