NS-Park network Clinical research network for Parkinson’s disease and Movement Disorders Jean-Christophe Corvol Maladie de Parkinson Prévalence : 2% de la population > 65 ans 150 000 patients en France Corps de Lewy Dégénérescence des neurones dopaminergiques Akinésie Rigidité Tremblement Syndromes apparentés : Atrophie multisystématisée, paralysie supranucléaire progressive, Dégénérescence cortico-basale, démence à corps de Lewy… Parkinson’s disease Evolution and treatment Treatment of motor complications Prevention of motor complications Neuroprotection Dopaminergic lesions De Novo PD Honeymoon Dopaminergic drugs •Fluctuations •Dyskinesia Deep brain stimulation •Gait failure •Dementia Non motor symptoms Extra-dopaminergic lesions PD’s major challenges Physiopathology Disease modifiers Study design Early diagnosis SNCA LRRK2 MAPT Lancet 2011 Motor symptoms Non motor symptoms Rating scales NEJM 2009 Rare diseases New targets Brain 2009, Lancet Neurol, in press Lancet Neurol, 2012 Brain imaging Personnalized medicine Medical strategies Devices Biomarker of progression Devices Lancet Neurol 2012 Brain 2013 Medical strategies Ann Neurol 2011 NS-Park - Project Working Groups Task 1 Task 2 Task 3 Task 4 Task 5 Early diagnosis WG1 Early diagnosis and genetics of PD WG2 Motor symptoms and complications of PD Prevention WG3 Non-motor symptoms of PD Treatment WG4 Late PD Rescue WG5 Rare movement disorders New targets 24 PD expert centers 16 CIC > 12,000 patients Historical NS-Park centers CIC & movement disorder Clinic Bordeaux Clermont Créteil Dijon Grenoble Lille Lyon Marseille Montpellier Nantes Paris Poitier Rouen Strasbourg Toulouse Pr F Tison Pr F Durif Pr P Remy Pr M Giroud Pr P Krack Pr A Destee Pr E Broussolle Pr JP Azulay Pr C Geny Pr P Derckinderen Pr JC Corvol Pr JL Houetto Pr D Maltête Pr C Tranchant Pr O Rascol Associated centers Guichet unique: 2 chefs de projet Amiens Aix Besançon Caen Limoges Nancy Nice Reims Pr P Krystkowiak Dr F Viallet Pr P Remy Pr G Defer Dr F Torny Dr RN Gospodaru Dr C Giordana Dr A Doé de Maindreville Coordination Chair: Pr Corvol, Pr Rascol, Pr Durif Steering committee Working groups Transversal tasks Early diagnosis Genetics Motors complications Non motor symptoms Chair: Pr Brice, Pr Destée, Chair: Pr Rascol, Pr Corvol, Chair: Pr Krack, Pr Durif, Dr Brefel-Courbon, Pr Houeto, Pr Vérin Rares diseases and other movement disorders Late PD Chair: Pr Anheim, Pr Meissner, Pr Vidailhet Chair: Pr Azulay, Pr Dujardin, Dr Welter Databases Chair: Pr Corvol, Pr Meissner, Pr Lehericy, Pr Thobois, Pr Remy, Dr Eusebio, Pr Burbaud Clinical trials methods Rating scales Chair: Pr Rascol, Dr Devos Relationships with preclinical teams and industry Chair: Pr Tison, Pr Remy 24 NS-Park centers + Partners Education Chair: Pr Tranchant, Pr Defebvre NS-Park - Expertise • • • • • • • • Basic research (Paris, Marseille, Lyon) Preclinical research (Neuratris, Bordeaux) DBS (Grenoble) Study design (Toulouse) Rating scales (MDS-UPDRS, ECMP, LARS…) Brain imaging (CATI) Dedicated biobank (BioCollection) Project managers – – – – Grant preparation Feasibility Hospital costs, agreements Study coordination and follow-up • European network NS-Park – Major publications EU RCT (France-Germany) Device PI: Y Agid (Paris) 8 NEJM 2013 French multicenter RCT Drug – non motor PI: Devos (Lille) 11 Lancet Neurol 2012 International (UK-GermanyFrance-Netherlands-USA) Genetics. PI: A. Brice (Paris) 12 Lancet 2011 French multicenter RCT Drug - motor PI: Rascol (Toulouse) 7 Neurology, 2013 French multicenter RCTs Rare disease PI: F Durif (Clermont Ferrand) 6 Neurology, 2013 EU RCT (France-Germany-UK) Rare disease PI: G. Bensimon (Paris) 11 Brain 2009 NS-Park - Activity 30 clinical studies 18 Phase II 40% Phase III 27% Phase IV 10% 16 Number of studies Other* 23% Phase IV 14 12 Phase III 10 8 Phase II 6 Other 4 2 0 *cohortes, rating scale validation Academic Rare MD 13% National 53% International 47% Industry Disase modifying 3% Non motor 20% Dyskinesia 27% Motor 37% NS-Park – Ongoing studies Etudes en cours • Académiques – PREMANDYSK (Toulouse, Rascol) prévention dyskinésies – BADGE-PD (Paris, Corvol), pharmacogénétique – APATHIE (Clermont, Durif), rasagiline – BEAD-PD (Paris, Corvol), pharmacogénétique • Etudes industrielles – Completed: Novartis, Addex, Allon, BIA – Phase II, salivation, NeuroHealing Etudes à venir, collaborations • Académiques – MSA-DOPS (Toulouse, Rascol) – PREDISTIM (Lille, Devos) – STARTLATE (Paris, Welter), stimulation • Collaborations industrielles – – – – – – – Biomarqueurs, IPSEN, SANOFI Comp. motrices, IPSEN Phase I, AFFIRIS Phase II, CHELSEA, APOPHARMA, Phase II-III, LILLY Phase III, STADA Autres: ONO, Ad Scientiam, Neurolixis, B&A therapeutics… NS-Park pipeline Sanofi RD Ipsen RD B&A therapeutics Drug development ONO pharma Ipsen Biomarkers AFFIRIS Neurohealing Preclinical models POC, phase II Neurolixis Lilly Phase III STADA Chelsea Basic research Physiology Personalized medicine Repositionning Phase IV Lundbeck Apopharma NS-Park – Database and registry Clinical database Medical activity, registry, cohorts, CRF Imaging database SOPs for brain MRI and DATscan Centre d’Analyse et de Traitement des Images Biobank Parkinson’s disease biobank NS-Park – European strategy Number of clinical trials in EU in Parkinson’s disease Source: ClinicalTrial.gov (2014) NS-Park – European strategy O Rascol: Chair of the MDS European Section: ⇒ Identify EU networks in the field of PD and movement disorders ⇒Joint application to EU calls (Horizon 2020) David Burn T. Klockgether Austria: Werner Poewe Spain: Eduardo Tolosa Italy: Paolo Barone Shared with INIs Legal counseling EU lobbying Education Quality Patents FCRIN platforms Data managment Statistics Methodology Drug manufacturing FCRIN Office Industrial Partners Other EU networks PD Genetics DenDRON KKS Clinical research infrastructures CATI (Center for Image Acquisition and Processing) BioCollection Neuratris Reference Centers rare diseases Gilles de la Tourette MSA Dystonia Clinical Novartis Merck Addex Kyowa Chelsea UCB Neuroderm … Preclinical Ipsen Sanofi UCB ONO Medtronic … Patients associations AMADYS PSP France Parkinson Genetic PSP France ARAMISE APTES Why use NS-Park? • EU grant (Horizon 2020) in PD or aging • Clinical trials in PD or movement disorders – POC studies, design, feasibility, recruitment, follow-up… • Biomarker research (wet or imaging) • Device development for PD • Rare patients: genetic forms (LRRK2, GBA…), rare movement disorders How to use NS-Park? • Coordination: JC Corvol (Pitié-Salpêtrière) F Durif (Clermont-Ferrand) O Rascol (Toulouse) • Project managers: – Véronique Chaigneau or Estelle Dellapina – Tel: 05.61.77.24.07 – Email: [email protected] • Web site: http://reseau-cic-parkinson.inserm.fr/ Thank you ! NS-Park - Funds and budget Shared with other INI 15% Coordination 23% Databases 19% Centers 24% Driving initiatives 19% Incomes (k€) 400 350 300 250 200 150 100 50 0 2014 2015 FCRIN 300 Incomes (k€) 250 200 2 project managers + operating costs to sustain NS-Park Project coordination Valorization 100 Industrial fees 50 INSERM 2015 2016 2017 2018 2017 Other incomes CRA in centers 150 0 2014 2016 2018
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