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    Summary
    EudraCT Number:2015-003679-31
    Sponsor's Protocol Code Number:2015_22
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-01-28
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2015-003679-31
    A.3Full title of the trial
    Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease
    Konzervativní chelatace železa jako strategie měnící přístup k léčbě Parkinsonovy nemoci
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    New therapeutic strategy in Parkinson’s disease
    Nový léčebný přístup u Parkinsonovy nemoci
    A.3.2Name or abbreviated title of the trial where available
    FAIRPARK II
    A.4.1Sponsor's protocol code number2015_22
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCentre Hospitalier Régional et Universitaire de Lille
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEuropean Union’s Horizon 2020 research and innovation programme
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier Régional et Universitaire de Lille
    B.5.2Functional name of contact pointFédération de recherche clinique
    B.5.3 Address:
    B.5.3.1Street Address6 rue du Professeur Laguesse
    B.5.3.2Town/ cityLille
    B.5.3.3Post code59037
    B.5.3.4CountryFrance
    B.5.4Telephone number33320 44 41 45
    B.5.5Fax number33320 44 57 11
    B.5.6E-mailDRS.PROMOTION@CHRU-LILLE.FR
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDeferiprone DR
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEFERIPRONE
    D.3.9.1CAS number 30652-11-0
    D.3.9.4EV Substance CodeSUB06941MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    De Novo Parkinson’s disease
    Nově diagnostikovaná Parkinsonova nemoc
    E.1.1.1Medical condition in easily understood language
    De Novo Parkinson’s disease
    Nově prokázaná Parkinsonova nemoc
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the FAIR-PARK II trial is to demonstrate an effect of DFP on the course of PD (including both disease-modifying and symptomatic effects).
    Hlavním cílem FAIR-Park II studie je prokázat vliv DFP na průběh PN
    (jak modifikující efekt na chorobu, tak účinek na symptomy).
    E.2.2Secondary objectives of the trial
    1-The disease-modifying effect
    2- The global effect on motor and non-motor symptoms
    3-Effects on quality of life and autonomy
    4-A health economics assessment will be performed via a specific questionnaire and EQ-5D questionnaire
    5-A biomarker analysis to assess the biomarkers' potential surrogate value :
    • MRI,Dopamine transporter (DaT) scan,Transcranial ultrasound
    • Data from the continuous assessment of PD-relevant domains with an unobtrusive, continuous; quantitative measurement tool
    • Surrogate marker: Iron metabolism: ferritin ,Ceruloplasmin levels, ceruloplasmin ferroxidase activity, and the ceruloplasmin genotype;the COMT Val158Met polymorphism will be assessed
    • Heavy metal assays: blood iron zinc,copper,magnesium,chrome,manganese, nickel,lead and cadmium levels, 24-hour urine copper and zinc levels.
    • Oxidative stress ,A specific biochemistry screen
    • Vitamins B1,B6,B12, E, A,and C,folates.
    • Inflammatory factors: tumour necrosis factor alpha and interleukin-6
    1- Účinek modifikující chorobu
    2- Celkový efekt na motorické a nemotorické příznaky
    3- Vliv na kvalitu života a nezávislost
    4- Posouzení zdravotní ekonomiky se bude provádět prostřednictvím
    specifického dotazníku a EQ-5D dotazníku
    5- Analýza biomarkerů jako prediktorů efektu:
    • MRI, zobrazení dopaminového transportéru (DaT), transkraniální
    ultrazvuk
    • Data z průběžného hodnocení motorického stavu PD- relevantních
    oblastí získaná pomocí kvantitativního nástroje pro měření motoriky
    • Prediktivní biomarkery: metabolismus železa: ferritin, hladiny
    ceruloplasminu, ferroxidázová aktivita ceruloplasminu a genotyp
    ceruloplasminu; COMT Val158Met polymorfismus
    • Detekce těžkých kovů: v krvi hladiny železa, zinku, mědi, hořčíku,
    chromu, manganu, niklu, olova a kadmia, a ve vzorku moči z 24-
    hodinového sběru: měď a zinek.
    • Oxidační stres, specifický biochemický screening
    • Vitamíny B1, B6, B12, E, A a C, foláty.
    • Zánětlivé faktory: tumor nekrotizující faktor alfa a interleukin-6
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult Patients
    2. Parkinson’s disease diagnosed according The Movement Disorder Society Clinical Diagnotic Criteria for Parkinson’s Disease (PD).
    3. Treatment-naïve, i.e. the best population for assessing a disease-modifying effect without the interaction of dopaminergic treatment (no dopaminergic agonists, L-dopa, anticholinergics, monoamine oxidase B inhibitors (e.g. rasagiline) or deep brain stimulation).
    4. Patients covered by a Health Insurance System in countries where required by law
    5. Written informed consent dated and signed prior to the beginning of any procedures related to the clinical trial
    1. Dospělí pacienti
    2. Parkinsonova nemoc diagnostikována podle The Movement Disorder Society Clinical Diagnotic Criteria for Parkinson’s Disease (PD).
    3. Neléčení nemocní, tedy nejlepší populace pro hodnocení chorobu
    modifikujícího efektu bez interakcí s dopaminergní léčbou (bez
    dopaminergních agonistů, L-dopy, anticholinergik, inhibitorů
    monoaminooxidázy B (např rasagilin) nebo hluboké mozkové stimulace).
    4. Pacienti, kteří jsou zdravotními pojištěnci v zemích, kde je to
    požadováno dle zákona
    5. Písemný informovaný souhlas s datem a podpisem před zahájením
    jakýchkoli záležitostí týkajících se klinického hodnocení
    E.4Principal exclusion criteria
    1. Disease duration greater than 18 months.
    2. Patients with high frequency of comorbidity or vital risks that may reasonably impair life expectancy
    3. Subject with handicap required dopaminergic treatment at the inclusion and therefore likely not to bear 9 months without symptomatic treatment
    4. Hoehn and Yahr stage 3 or more.
    5. Significant cognitive impairment (a Mini Mental State Examination score <24 or an equivalent impairment on a similar scale) or dementia diagnosed in accordance with the Movement Disorders Society criteria (Emre et al., 2007).
    6. Atypical or secondary parkinsonism (supranuclear palsy, multisystem atrophy, etc.) or significant cortical or subcortical atrophy (i.e. atypical for PD).
    7. Progressing axis I psychiatric disorders (psychosis, hallucinations, substance addiction, bipolar disorder, or severe depression), in accordance with the Diagnostic and Statistical Manual of Mental Disorders.
    8. Subjects undergoing brain stimulation
    9. Due to the high risk of agranulocytosis caused by the IMP and the unknown mechanism by which this agranulocytosis is induced, it is not allowed to combine Deferiprone with other medicinal products causing agranulocytosis (as described in the IB). Such medicinal products are the already mentioned clozapine and also some NSAIDs (e.g. Phenylbutazone or Metamizole), antithyroid agents, sulfonamide antibiotics or metothrexate.
    10. A history of relapsing neutropenia
    11. Hypersensitivity to deferiprone.
    12. Patients with agranulocytosis or with a history of agranulocytosis.
    13. Patients taking a treatment at risk of agranulocytosis (clozapine, Closaril®/Leponex®).
    14. Patients with anaemia (regardless of the latter's aetiology) or a history of another haematological disease. Haemochromatosis is not an exclusion criterion.
    15. Pregnant or breastfeeding women or women of childbearing potential not taking highly effective contraception.
    16. Kidney or liver failure.
    17. Other serious diseases.
    18. Inability to provide informed consent.
    19. Participation in another clinical trial with investigational medicinal product within 3 months prior to inclusion in the study
    20. Patient who has suffered mild or moderate depressive episode and isn’t in remission and on a stable medication for at least 8 weeks
    21. Patient > 130kg

    o Exclusion criteria for the biomarker study and the ancillary study
    (i) MRI:
    • Subjects for whom MRI is contraindicated (metal objects in the body, severe claustrophobia, pacemaker, incompatible surgical material).
    • Very severe rest tremor, which could induce MRI artefacts.
    (ii) Lumbar puncture:
    • Blood coagulation disorders, antiplatelet drugs or anticoagulants.
    • Intracranial hypertension.
    (iii) Contraindications to nitrous oxide:
    • Ventilation with FiO2 >50%, emphysema or pneumothorax
    • Altered states of consciousness, non-cooperative patient (need to stop the nitrous oxide)
     
    1. Doba trvání nemoci delší než 18 měsíců.
    2. Pacienti s četnou komorbiditou nebo vitálními riziky, která mohou mít
    vliv na délku jejich života.
    3. Subjekty s postižením vyžadujícím dopaminergní léčbu při vstupu, a
    kteří se tudíž pravděpodobně bez této symptomatické léčby po dobu 9
    měsíců neobejdou.
    4. Hoehn a Yahr stupeň 3 nebo vyšší.
    5. Významné poruchy kognitivních funkcí (Mini Mental State Examination
    skóre <24 nebo ekvivalentní snížení hodnoty v podobném rozsahu),
    nebo demence diagnostikovaná v souladu s kritérii Movement Disorders
    Society (Emre et al., 2007).
    6. Atypický nebo sekundární parkinsonismus (supranukleární obrna,
    multisystémová atrofie, atd.), nebo anomálie na MRI naznačující
    postižení cév nebo významnou kortikální nebo subkortikální atrofii (tj.
    atypickou pro PN).
    7. Progredující duševní poruchy (psychózy, halucinace, drogová závislost, bipolární porucha, nebo těžká deprese), v souladu s Diagnostic and Statistical Manual of Mental Disorders.
    8. Subjekty se zavedenou hlubokou mozkovou stimulací.
    9. Vzhledem k vysokému riziku agranulocytózy způsobené IMP a neznámému mechanismu, kterým je indukována agranulocytóza, není povoleno kombinovat Deferipron s jinými léčivými přípravky způsobujícími agranulocytózu (jak je popsáno v IB). Takovými léčivými přípravky jsou již zmíněný clozapin a také některé NSAID (např. Fenylbutazon nebo metamizol), antithyroidní látky, sulfonamidové antibiotika nebo metothrexát.
    10. Anamnéza recidivující neutropenie
    11. Hypersenzitivita na deferipron.
    12. Pacienti s agranulocytózou nebo s anamnézou agranulocytózy.
    13. Pacienti léčení rizikem agranulocytózy (klozapin, Closaril® / Leponex®).
    14. Pacienti s anémií (bez ohledu na jejich etiologii) nebo s anamnézou dalšího hematologického onemocnění. Hemochromatóza není kritériem vyloučení.
    15. Těhotné nebo kojící ženy nebo ženy ve fertilním věku, které nepoužívají vysoce účinnou antikoncepci.
    16. Selhání ledvin nebo jater.
    17. Jiné závažné nemoci.
    18. Neschopnost poskytnout informovaný souhlas.
    19. Účast na další klinické studii v období 3 měsíců před zařazením do studie.
    20. Pacient, který trpí mírnou nebo středně závažnou epizodou deprese, není v remisi a na stabilní medikaci po dobu nejméně 8 týdnů.
    21. Pacient> 130 kg
    o Kritéria pro vyzaření pro biomarkerovou studii a pomocnou studie
    (i) MRI:
    Vylučovací kritéria pro studium biomarkerů a doplňkovou studii (i) MRI:
    • Subjekty, pro něž MRI je kontraindikováno (kovové předměty v těle,
    závažná klaustrofobie, kardiostimulátor, nekompatibilní chirurgický
    materiál).
    • Velmi těžký klidový třes, což by mohlo vyvolat MRI artefakty.
    (ii) Lumbální punkce:
    • poruchy srážení krve, protisrážlivé léky nebo antikoagulancia.
    • nitrolební hypertenze.
    (iii) Kontraindikace oxidu dusného:
    • Ventilace s FiO2> 50%, rozedma plic nebo pneumotorax
    • změněné stavy vědomí, nespolupracující pacient (kdy je třeba zastavit
    přísun oxidu dusného).
    E.5 End points
    E.5.1Primary end point(s)
    the change in the total MDS-UPDRS
    změna celkového MDS-UPDRS skóre
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 0, week12; week24; week36; week40
    týden 0, týden 12; týden 24; týden 36; týden 40
    E.5.2Secondary end point(s)
    (i) MDS-UPDRS score between baseline and week 40
    (ii) MDS-UPDRS (part I: cognition and behaviour; part II: activities of daily living; part III: motor handicap; part IV: fluctuations), the Stand Walk Sit test, overall cognitive status (score in the Montreal Cognitive Assessment) between baseline and week 36; and between baseline and week 40
    (iii) Effects on quality of life and autonomy will be analyzed as the change in the Parkinson’s Disease Quality of Life (PDQ-39, via a 39-item self-questionnaire) and the Clinical Global Impression scored by the examiner and the patient between baseline and week 36, and between baseline and week 40 f
    (iv) A health economics assessment will be performed via a specific questionnaire and EQ-5D questionnaire (It provides a simple descriptive profile and a single index value for health status) between baseline and week 36, and between baseline and week 40
    (v) A biomarker analysis to assess the biomarkers' potential surrogate value
    -MRI
    - Dopamine transporter (DaT) scan
    - Transcranial ultrasound
    - Data from the continuous assessment of PD-relevant domains with an unobtrusive, continuous
    -A specific biochemistry screen
    (i) MDS-UPDRS skóre mezi výchozím stavem a 40. týdnem
    (ii) MDS-UPDRS (díl I: kognitivní funkce a chování, část II: činnosti
    každodenního života, část III: motorické postižení; část IV: kolísání),
    Stand Walk Sit test, celkový kognitivní stav (skóre v Montreal Cognitive
    Assesment) mezi stavem výchozím a stavem v 36. týdnu; a mezi
    výchozím stavem a stavem ve 40. týdnu
    (iii) Vliv na kvalitu života a nezávislost se analyzují jako změna v kvalitě
    života u Parkinsonovy choroby (PDQ-39, přes položku 39 - sebehodnotící
    dotazník) a Celkový Klinický Dojem hodnocený zkoušejícím a pacientem
    mezi výchozím stavem a v 36. týdnu a mezi výchozím stavem a ve 40.
    týdnu
    (iv) Posouzení zdravotní ekonomiky se bude provádět prostřednictvím
    specifického dotazníku a EQ-5D dotazníku (poskytuje jednoduchý
    popisný profil a jedinou hodnotu indexu pro zdravotní stav) mezi výchozí
    situací a v 36.týdnu a mezi výchozím stavem a v 40.týdnu
    (v) Analýza biomarkerů posuzující jejich náhradní hodnoty
    - MRI
    - Dopaminový transportér (DaT) scan
    - Transkraniální ultrazvuk
    - Data z průběžného hodnocení PD-relevantních oblastí, diskrétní,
    nepřetržitá
    - Specifický biochemický screening
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 0, week36; week40
    týden 0, týden 36; týden 40
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Poslední vizita posledního pacienta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 169
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 169
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 338
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-23
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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