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    Summary
    EudraCT Number:2015-003679-31
    Sponsor's Protocol Code Number:2015_22
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-01-13
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-003679-31
    A.3Full title of the trial
    Conservative iron chelation as a disease-modifying strategy in Parkinson?s disease: a multicentre, parallel-group, placebo-controlled, randomized clinical trial of deferiprone
    Quelación conservadora de hierro como estrategia modificadora de la enfermedad de Parkinson: ensayo clínico de deferiprona multicéntrico, de grupos paralelos, aleatorizado, controlado con placebo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    New therapeutic strategy in Parkinson?s disease
    Nueva estrategia terapéutica en la Enfermedad de Parkinson
    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 pointAmélie Herbaut Lecocq
    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-maildrc@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 Yes
    D.2.1.1.1Trade name Ferriprox 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderApotex Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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
    Enfermedad de Parkinson de novo
    E.1.1.1Medical condition in easily understood language
    De Novo Parkinson?s disease
    Enfermedad de Parkinson de novo
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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).
    Demostrar un efecto de la deferiprona en el curso de la enfermedad de Parkinson (incluyendo efectos modificadores de la enfermedad y efectos sintomáticos)
    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- biomarker analysis to assess the biomarkers' potential surrogate
    value
    1- efecto modificador de la enfermedad
    2- efecto global en síntomas motores y no-motores
    3- efectos en la calidad de visa y autonomía
    4- evaluación del impacto económico en salud mediante cuestionario EQ-5D
    5-Búsqueda de potenciales biomarcadores.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult patients
    1.2. Parkinson?s disease diagnosed according UK Parkinson?s disease Society Brain Bank Clinical Diagnostic Criteria and based on the presence of at least two of the three cardinal features of the disease (rest tremor, bradykinesia and rigidity). If rest tremor is not present, subjects must have unilateral onset of symptoms.
    2. Aged under 80.
    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 countires where required by law.
    5. Written informed consent dated and signed prior to the beginning of any procedures related to the clinical trial
    1. Pacientes adultos
    2. Enfermedad de Parkinson diagnosticada de acuerdo con los criterios clínicos de diagnóstico de la UK Parkinson?s disease Society Brain Bank y basados en la presencia de almenos dos de los tres ejes centrales de la enfermedad (temblor en reposo, bradiquinesia y rigidez). Si el temblor en reposo no está presente los sujetos deben tener inicio de síntomas unilateral.
    3. Naïve para tratamiento es decir la mejor población para evaluar un efecto modificador de la enfermedad sin interacción de fármacos dopaminérgicos (sin agonistas dopaminérgicos, L-dopa, anticolinérgicos, inhibidores de la monoamin oxidasa B (ej. rasagilina) o estimulación cerebral profunda.
    4. Pacientes con cobertura sanitaria nacional en países en los que sea un requisito legal
    5. Que hayan firmado y fechado consentimiento por escrito antes del inicio de cualquier procedimiento relacionado con el ensayo clínico.
    E.4Principal exclusion criteria
    1. 1. Disease duration greater than 18 months.
    2. Patients with high frequency of comorbidity or vital risks that may reasonably impair life expectancy
    3. Subjects with a handicap likely to require symptomatic dopaminergic treatment in the coming nine months 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 anomalies on MRI suggestive of vascular involvement 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. Positive HIV serology.
    10. Hypersensitivity to deferiprone.
    11. Patients with agranulocytosis or with a history of agranulocytosis.
    12. Patients taking a treatment at risk of agranulocytosis (clozapine, Closaril®/Leponex®).
    13. Patients with anaemia (regardless of the latter's aetiology) or a history of another haematological disease. Haemochromatosis is not an exclusion criterion.
    14. Pregnant or breastfeeding women or menopausal women of childbearing potential not taking highly effective contraception.
    15. Kidney or liver failure.
    16. Other serious diseases.
    17. Inability to provide informed consent.
    18. Participation in another clinical trial within 3 months prior to inclusion in the study
    19. Patient who has suffered mild or moderate depressive episode and isn?t in remission and on a stable medication for at least 8 weeks.
    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. La duración de la enfermedad es superior a 18 meses
    2. Pacientes con alta frecuencia de comorbilidad o riesgos vitales que perjudiquen razonablemente la esperanza de vida
    3. Sujetos con una limitación que requiera tratamiento dopaminérgico en la inclusión y que por tanto no se puede plantear 9 mesessin recibir tratamiento sintomático.
    4. Estadío Hoehn and Yahr de 3 o superior.
    5. Deterioro cognitivo significativo (Puntuación < 24 en test Mini mental o un deterioro equivalente en escala similar) o demencia diagnosticada de acuerdo con criterios de ?Movement Disorders Society? (Emre et al., 2007)
    6. Parkisonismo atípico o secundario (parálisis supranuclear, atrifia multisistema, etc) o anormalidades en RM que sugieran implicación vascular o atrofia cortical o subcortical significativa (es decir atípica para EP)
    7. Trastorno psiquiátrico progresivo Axis I (psicosis, alucinaciones, adicción a sustancias, desorden bipolar o depresión severa) de acuerdo con el ?Diagnostic and Statistical Manual of Mental Disorders?
    8. Pacientes bajo estimulación cerebral
    9. Serología positiva de VIH
    10. Hipersensibilidad a deferiprona
    11. Pacientes con agranulocitosis o con historia de agranulocitosis.
    12. Pacientes en tratamiento por riesgo de agranulocitosis (clozapina, closaril®/leponex®)
    13. Pacientes con anemia (independientemente de la etiología posterior) o historia de otra enfermedad hematológica. Hematocromatosis no es un criterio de exclusión.
    14. Embarazadas, lactantes o mujeres en edad fértil que no utilicen métodos anticonceptivos de alta efectividad.
    15. Fallo renal o hepático
    16. Otras enfermedades graves
    17. Incapacidad para otorgar consentimiento informado
    18. Participación en otro ensayo clínico dentro de los 3 meses previos a la inclusión en el estudio.
    19. Pacientes que han padecido algún episodio de depresión moderada o leve y que no está en remisión o en tratamiento estable de al menos 8 semanas.
    Criterios de exclusión para estudio de biomarcadores y estudis adicionales
    (i) RM:
    ? Sujetos en lso que la RM está contraindicada (con algún objeto metálico en organismo,con claustrofobia grave, marcapasos, material quirúrgico incompatible).
    ? Temblor en reposo muy grave, que podría implicar artefactos en la RM.
    (ii) Punción lumbar:
    ? Sangre coagulación trastornos, antiplaqueta fármacos or anticoagulantes.
    ? Hipertensión intracranial.
    (iii) Contraindicaciones a óxido nitroso:
    ? Ventilación con FiO2 >50%, efisema o neumotórax
    ? Estado de consciencia alterado, paciente no cooperador (necesidad de detener el óxido nitroso)
    E.5 End points
    E.5.1Primary end point(s)
    the change in the total MDS-UPDRS
    Cambio den la puntuación total de la MDS-UPDRS
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 0, week12; week24; week36; week40
    semana 0, semana 12, semana 24, semana 36 y semana 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) safety criteria
    Exploratory variables: A biomarker analysis
    (i) cambios en la puntuación global en la escala MDS-UPDRS entre la basal y la semana 40
    (ii) Efecto global en síntomas motores y no-motores: se analizará como el cambio en las diferentes subescalas del MDS-UPDRS (parte I: cognición y conducta; parte II: actividades del día a día; parte III: limitaciones motoras; parte IV: fluctuación) y partes II+III del MDS-UPDRS, el test Stand Walk Sit, estatus cognitivo global (puntuación en Montreal Cognitive Assessment)
    (iii) Los efectos en la calidad de vida y autonomía se evaluarán como cambios en las puntuaciones en la escala Parkinson?s Disease Quality of Life (PDQ-39; un cuestionario de autoevaluación de 39 puntos) y la escala Clinical Global Impression
    (iv) La evaluación del impacto económico en salud se realizará mediante la utilización de un cuestionario específico y el cuestionario EQ-5D
    (V)criterios de seguridad
    variables exploratorias: biomarcadores
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 0, week36; week40
    semanas 3, 36 y 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Última visita de último paciente
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 338
    F.4.2.2In the whole clinical trial 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
    ninguno
    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 Decision2016-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-15
    P. End of Trial
    P.End of Trial StatusOngoing
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