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    Summary
    EudraCT Number:2017-002426-20
    Sponsor's Protocol Code Number:Z7219M01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-20
    Trial results View 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 number2017-002426-20
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain
    Estudio aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de safinamida 100 mg una vez al día, como tratamiento complementario, en pacientes con enfermedad de Parkinson idiopática (EPI) con fluctuaciones motoras y dolor crónico relacionado con la enfermedad de Parkinson
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Safinamide on Parkinson’s Disease Related Chronic Pain
    Efecto de la safinamida en el dolor crónico relacionado con la enfermedad de Parkinson
    A.3.2Name or abbreviated title of the trial where available
    Pain study
    Estudio del dolor
    A.4.1Sponsor's protocol code numberZ7219M01
    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 SponsorZambon SpA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZambon SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZambon SpA
    B.5.2Functional name of contact pointLuca Raiteri
    B.5.3 Address:
    B.5.3.1Street AddressVia Lillo de Duca 10
    B.5.3.2Town/ cityBresso, Milan
    B.5.3.3Post code20091
    B.5.3.4CountryItaly
    B.5.4Telephone number900 834 223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.com
    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 Xadago
    D.2.1.1.2Name of the Marketing Authorisation holderZambon SpA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameXadago
    D.3.4Pharmaceutical form Film-coated 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 INNSafinamide methansulfonate
    D.3.9.1CAS number 202825-46-5
    D.3.9.3Other descriptive nameSAFINAMIDE METHANESULFONATE
    D.3.9.4EV Substance CodeSUB130363
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    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 Xadago
    D.2.1.1.2Name of the Marketing Authorisation holderZambon SpA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameXadago
    D.3.4Pharmaceutical form Film-coated 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 INNSafinamide methansulfonate
    D.3.9.1CAS number 202825-46-5
    D.3.9.3Other descriptive nameSAFINAMIDE METHANESULFONATE
    D.3.9.4EV Substance CodeSUB130363
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the “ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain.
    Enfermedad de Parkinson idiopática, estadio Hoehn y Yahr entre 2-3 inclusive durante la fase "ON", experimentando fluctuaciones motoras mientras se encuentran en dosis estables de L-Dopa (con benserazida/carbidopa o sin esta, con o sin adición de COMT inhibidor) y puede estar recibiendo dosis estables de otros medicamentos para la EP, pero están experimentando más de 2 horas de tiempo de inactivación por día y dolor relacionado con la EP crónica.
    E.1.1.1Medical condition in easily understood language
    chronic pain in PD patients, experiencing motor fluctuations while on stable doses of L-dopa
    Dolor crónico en pacientes con EP, que experimentan fluctuaciones motoras mientras reciben dosis estables de L-dopa
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10013113
    E.1.2Term Disease Parkinson's
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the potential efficacy of safinamide 100 mg once daily, compared to placebo, as add-on therapy, for PD related chronic pain
    Evaluar la posible eficacia de safinamida 100 mg una vez al día, en comparación con placebo, como tratamiento complementario, en el dolor crónico relacionado con la EP.
    E.2.2Secondary objectives of the trial
    - The percentage of pain responders
    - Clinical Global Impression for pain
    - Patient Global Impression for pain
    - Reduction of pain drugs
    - Mood
    - Dyskinesia
    - Safety & Tolerability
    - Porcentaje de pacientes con respuesta del dolor
    - Impresión clínica global del dolor
    - Impresión global del paciente del dolor
    - Reducción de analgésicos
    - Estado de ánimo
    - Discinesia
    - Seguridad y tolerabilidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be 30 years of age or older, at the time of signing the informed consent.
    2. Diagnosed with IPD by using the United Kingdom Parkinson’s Disease Society Brain Bank criteria for more than 5 years duration.
    3. Receiving treatment with a stable dose of oral L-Dopa (including controlled release [CR], immediate release [IR] or a combination of CR/IR), with and without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor and may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine for at least 4 weeks prior to the randomisation (baseline visit).
    4. Hoehn and Yahr stage between 2-3 (inclusive) during the “ON” phase at the screening visit.
    5. Experiencing motor fluctuations following optimum titration of treatment medications and within the 4 weeks immediately prior to randomisation.
    6. Experiencing a minimum of 2.0 hours/day of “OFF” time during the day (excluding morning akinesia).
    7. Experiencing chronic pain (i.e. ongoing for >=3 months prior to screening visit); the Investigator must consider chronic pain directly related to PD and not explained by any other health problem (e.g. peripheral neuropathy, organ disease or arthritis pain) OR consider the intensity of chronic pain specifically aggravated by PD.
    8. On a stable treatment regimen of analgesics in the 4 weeks prior to the randomisation visit.
    9. Able to maintain an accurate and complete electronic diary with the help of a caregiver.
    10. Male or female
    a. Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix 4), not breastfeeding, and at least one of the following conditions applies:
    i. Not a woman of childbearing potential (WOCBP) as defined in Appendix 4
    or
    ii. A WOCBP who agrees to follow the contraceptive guidance in Appendix 4.
    11. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    1. El participante tiene 30 años o más de edad en el momento de firmar el consentimiento informado.
    2. Diagnóstico de EPI, según los criterios del Parkinson’s Disease Society Brain Bank del Reino Unido, durante más de cinco años.
    3. En tratamiento con una dosis estable de L-dopa oral (incluida L-dopa de liberación controlada [LC], de liberación inmediata [LI] o una combinación de LC/LI), con o sin benserazida/carbidopa y con o sin la adición de un inhibidor de la catecol-O-metiltransferasa (COMT), y posibilidad de estar recibiendo tratamiento concomitante con dosis estables de un agonista dopaminérgico, un anticolinérgico o amantadina durante al menos cuatro semanas antes de la aleatorización (visita basal).
    4. Estadio de Hoehn y Yahr de entre 2 y 3 (inclusive) durante la fase “ON” en la visita de selección.
    5. Aparición de fluctuaciones motoras tras un ajuste óptimo de la medicación terapéutica y en las cuatro semanas inmediatamente anteriores a la aleatorización.
    6. Presencia de un mínimo de 2,0 horas/día de tiempo “OFF” durante el día (excluida la acinesia matutina).
    7. Presencia de dolor crónico (es decir, persistente durante >=3 meses antes de la visita de selección); el investigador debe considerar el dolor crónico relacionado directamente con la PE y no explicado por ningún otro problema de salud (p. ej., neuropatía periférica, enfermedad orgánica o dolor por artritis) O considerar la intensidad del dolor crónico agravado específicamente por la EP.
    8. En tratamiento estable con analgésicos en las cuatro semanas previas a la visita de aleatorización.
    9. Capacidad de llevar un diario electrónico exacto y completo con la ayuda de un cuidador.
    10. Varón o mujer.
    a. Mujeres: Una mujer podrá participar en el estudio si no está embarazada (véase el apéndice 4), no está amamantando y cumple al menos una de las condiciones siguientes:
    i. No es una mujer en edad fértil (MEF), según se define en el apéndice 4.
    O
    ii. Es una MEF y se compromete a seguir las normas relativas a métodos anticonceptivos recogidas en el apéndice 4.
    11. Capacidad para otorgar el consentimiento informado firmado según se describe en la sección 1, lo que incluye el cumplimiento de los requisitos y restricciones que se recogen en el documento de consentimiento informado y en este protocolo.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    1. Any form of Parkinsonism other than IPD.
    2. Diagnosis of chronic migraine (>15 days per month) or cancer pain.
    3. History of bipolar disorder, depression, schizophrenia or other psychotic disorder requiring treatment with neuroleptics.
    4. History of dementia or cognitive dysfunction.
    5. Severe, peak dose or biphasic dyskinesia.
    6. Unpredictable or widely swinging fluctuations.
    7. Ophthalmologic history including any of the following conditions: albinism, uveitis, retinitis pigmentosa, retinal degeneration, active retinopathy, severe progressive diabetic retinopathy, inherited retinopathy or family history of hereditary retinal disease.
    8. Moderate or severe liver failure using the Child-Pugh classification score.
    9. History of drug and/or alcohol abuse within 12 months prior to screening as defined by the current edition of the Diagnostic and Statistical Manual of Mental Disorders.
    10. Allergy/sensitivity or contraindications to the IMPs or their excipients, anticonvulsants, L-dopa or other anti-Parkinsonian drugs.
    Prior/Concomitant Therapy
    11. Treatment with monoamine oxidase inhibitors (MAOIs), levodopa infusion, pethidine, fluoxetine, fluvoxamine less than 4 weeks prior to the randomisation visit.
    12. Use of any investigational drug or device within 30 days prior to screening or 5 half-lives, whichever is the longest, or participation in a previous trial with safinamide or previous treatment with safinamide.
    13. Mini-Mental State Exam (MMSE) total score <24 at screening.
    14. NRS score ≤ 4 points at randomization visit.
    15. Any clinically significant condition which, in the opinion of the Investigator, would not be compatible with study participation or represent a risk for participants while in the study.
    Quedará excluido del estudio todo participante que cumpla alguno de los criterios siguientes:
    1. Cualquier forma de parkinsonismo distinta de la EPI.
    2. Diagnóstico de migraña crónica (> 15 días al mes) o dolor oncológico.
    3. Antecedentes de trastorno bipolar, depresión, esquizofrenia u otro trastorno psicótico que requiera tratamiento con neurolépticos.
    4. Antecedentes de demencia o disfunción cognitiva.
    5. Discinesia grave, de dosis máxima o bifásica.
    6. Fluctuaciones impredecibles o muy oscilantes.
    7. Antecedentes oftalmológicos que incluyan alguno de los trastornos siguientes: albinismo, uveítis, retinitis pigmentaria, degeneración retiniana, retinopatía activa, retinopatía diabética progresiva grave, retinopatía hereditaria o antecedentes familiares de retinopatía hereditaria.
    8. Insuficiencia hepática moderada o grave según la puntuación de Child-Pugh.
    9. Antecedentes de abuso de drogas o alcohol en los 12 meses previos a la selección, según se define en la edición vigente del Manual diagnóstico y estadístico de los trastornos mentales.
    10. Alergia/sensibilidad o contraindicaciones de los productos en investigación o sus excipientes, antiepilépticos, L-dopa u otros antiparkinsonianos.
    Tratamiento previo y concomitante
    11. Tratamiento con inhibidores de la monoaminooxidasa (IMAO), infusión de levodopa, petidina, fluoxetina o fluvoxamina menos de cuatro semanas antes de la visita de aleatorización.
    12. Uso de cualquier fármaco o dispositivo en investigación en los 30 días previos a la selección o el equivalente a cinco semividas del fármaco, lo que sea más largo, o participación en un ensayo previo con safinamida o tratamiento previo con safinamida.
    13. Puntuación total en el miniexamen cognoscitivo (MEC) < 24 en el período de selección.
    14. Puntuación en la EVN <= 4 puntos en la visita de aleatorización.
    15. Cualquier trastorno clínicamente significativo que, en opinión del investigador, no sería compatible con la participación en el estudio o representaría un riesgo para los participantes durante el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline to week 16 in pain severity (“average worst pain experienced in the last 7 days”), as assessed by an 11-point Numerical Rating Scale (NRS).
    Variación entre el momento basal y la semana 16 de la intensidad del dolor (“promedio del peor dolor experimentado en los últimos 7 días”), evaluada mediante una escala de valoración numérica (EVN) de 11 puntos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, Day 112
    Dia 1, dia 112
    E.5.2Secondary end point(s)
    - Participants with reduction in pain severity of >= 2 points (“average worst pain experienced in the last 7 days”), at week 16 as assessed by an 11-point NRS, compared to baseline.
    - The CGI-S score for pain at week 16.
    - The change from baseline to week 16 in the CGI-C score for pain.
    - The change from baseline to week 16 in the PGI-C score for pain.
    - The percentage of reduction in number of concomitant pain drugs from baseline to week 16.
    - Descriptive Safety & Tolerability
    - The number of patients with at least one intake of PRN pain medication.
    Amount of PRN pain medications.
    - The change from baseline to week 16 in the HADS score.
    - The change from baseline to week 16 in the MDS-UPDRS (total score and subscores) during the “ON” phase.
    - Participantes con una reducción de la intensidad del dolor >=2 puntos (“promedio del peor dolor experimentado en los últimos 7 días”) en la semana 16, evaluada mediante una EVN de 11 puntos, en comparación con el momento basal.
    - Puntuación CGI-S de dolor en la semana 16.
    - Variación de la puntuación CGI-S de dolor entre el momento basal y la semana 16.
    -Variación de la puntuación PGI-C de dolor entre el momento basal y la semana 16.
    - Porcentaje de reducción del número de analgésicos concomitantes entre el momento basal y la semana 16.
    - Número de pacientes con al menos una toma de analgésicos a demanda.
    - Cantidad de analgésicos a demanda.
    - Variación de la puntuación HADS entre el momento basal y la semana 16.
    - Variación de la puntuación MDS-UPDRS (puntuación total y subpuntuaciones) entre el momento basal y la semana 16 durante la fase “ON”.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, Day 28, Day 56, Day 112
    Dia 1, dia 28, dia 56, dia 112
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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 No
    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 del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days15
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 77
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 177
    F.4.2.2In the whole clinical trial 177
    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)
    Subject will be released into local standard of care.
    El paciente seguirá la práctica habitual
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation FCRIN NS-Park Network
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-03
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