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    Summary
    EudraCT Number:2013-004427-37
    Sponsor's Protocol Code Number:ESPP001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-09-04
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-004427-37
    A.3Full title of the trial
    Multicentre, randomised, double-blind, dose titration design in patients with Duchenne muscular dystrophy to evaluate the efficacy and the tolerability of the combinations of Ibuprofen (200 mg bid) and Isosorbide Dinitrate (20 mg, 40 mg, 60 mg, 80 mg)

    Studio multicentrico, randomizzato, in doppio cieco, con disegno a scalare in pazienti con Distrofia Muscolare di Duchenne per valutare l’efficacia e la tollerabilità della combinazione di Ibuprofene (200 mg bid) ed Isosorbide Dinitrato (20 mg, 40 mg, 60 mg, 80 mg)”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and tolerability of ibuprofen and isosorbide dinitrate (20 mg, 40 mg, 60 mg, 80 mg)
    Efficacia e tollerabilità di ibuprofen en isosorbide dinitrato (20 mg, 40 mg, 60 mg, 80 mg)
    A.3.2Name or abbreviated title of the trial where available
    ESPP001
    ESPP001
    A.4.1Sponsor's protocol code numberESPP001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPARENT PROJECT ONLUS
    B.1.3.4CountryItaly
    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 supportPARENT PROJECT ONLUS
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTFS Trial Form Support S.r.l
    B.5.2Functional name of contact pointPaola Vietti
    B.5.3 Address:
    B.5.3.1Street AddressViale Parioli n. 12
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00152
    B.5.3.4CountryItaly
    B.5.4Telephone number0039068076072
    B.5.5Fax number00390680693521
    B.5.6E-mailpaola.vietti@tfscro.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 Isosorbide Dinitrate 20 mg
    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 nameIsosorbide Dinitrate
    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 INNISOSORBIDE DINITRATE
    D.3.9.1CAS number 87-33-2
    D.3.9.4EV Substance CodeSUB08335MIG
    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 IBUPROFEN 200MG
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical 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 INNIBUPROFEN
    D.3.9.4EV Substance CodeSUB08098MIG
    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: 3
    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 Isosorbide Dinitrate 40 mg
    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 nameIsosorbide Dinitrate
    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 INNISOSORBIDE DINITRATE
    D.3.9.1CAS number 87-33-2
    D.3.9.4EV Substance CodeSUB08335MIG
    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: 4
    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 Isosorbide Dinitrate 60 mg
    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 nameIsosorbide Dinitrate
    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 INNISOSORBIDE DINITRATE
    D.3.9.1CAS number 87-33-2
    D.3.9.4EV Substance CodeSUB08335MIG
    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: 5
    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 Isosorbide Dinitrate 80 mg
    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 nameIsosorbide Dinitrate
    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 INNISOSORBIDE DINITRATE
    D.3.9.1CAS number 87-33-2
    D.3.9.4EV Substance CodeSUB08335MIG
    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
    Restrictive respiratory syndrome with frequent pulmonary infections and cardiomyopathy.
    wasting of skeletal muscle, severe local inflammation and, at least initially, muscle regeneration.
    Insufficienza respiratoria con infezioni polmonarie frequenti e cardiomiopatie.
    riduzione della tonicità del muscolo scheletrico, frequenti processi infiammatori locali, e inizialmente, rigenerazione del muscolo.
    E.1.1.1Medical condition in easily understood language
    Duchenne muscular dystrophy
    Distrofia muscolare di Duchenne
    E.1.1.2Therapeutic area Body processes [G] - Genetic Phenomena [G05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10064571
    E.1.2Term Gene mutation
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of the combination of ibuprofen and isosorbide dinitrate (ISDN) in delaying the worsening of the muscular motor function in patients with Duchenne muscular dystrophy assessed by the Performance of Upper Limb (PUL) scale.
    Valutare l'efficacia dell'associazione di ibuprofene e isosorbide dinitrato (ISDN) nel rallentare il peggioramento della funzione motoria muscolare in pazienti affetti da distrofia muscolare di Duchenne mediante l'impiego della scala di prestazione degli arti superiori (PUL, performance of upper limb).
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of the combination of ibuprofen and ISDN in Duchenne muscular dystrophy affected patients.
    To assess the efficacy of the combination of ibuprofen and ISDN assessed by other muscular, cardiac and pulmonary measures of functionality and also its impact on quality of life
    Valutare la sicurezza e la tollerabilità dell'associazione di ibuprofene e ISDN in pazienti affetti da distrofia muscolare di Duchenne.
    Valutare l'efficacia dell'associazione di ibuprofene e ISDN mediante ulteriori misurazioni della funzionalità muscolare, cardiaca e polmonare, nonché il suo impatto sulla qualità della vita.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 1. Patient written informed assent and parents/guardians written informed consent: provision of consent to participate in the study as shown by the signature on the Volunteer Consent Form after verbal and written information
    2. Confirmed diagnosis of Duchenne muscular dystrophy (muscle biopsy, genetic and biochemical analysis)
    3. Age ≥10 years and < 18 years
    4. Patients non-ambulant (at least 1 year in a wheelchair) within the last 6 years
    5. Patients who receive the standard of care for Duchenne muscular dystrophy as recommended by the Duchenne muscular dystrophy care recommendations
    6. Patients on chronic glucocorticosteroid treatment: dosage must be stable for at least 6 months prior to the admission to the study
    1. Assenso informato scritto del paziente e consenso informato scritto dei genitori/tutore: il conferimento del consenso alla partecipazione allo studio è attestato dalla firma del Modulo di consenso volontario apposta in seguito alle informazioni ricevute oralmente e per iscritto.
    2. Diagnosi confermata di distrofia muscolare di Duchenne (biopsia muscolare, analisi genetiche e biochimiche).
    3. Età ≥10 anni e <18 anni.
    4. Pazienti che negli ultimi 6 anni hanno mostrato un'incapacità di deambulazione (uso di sedia a rotelle per almeno 1 anno).
    5. Pazienti sottoposti alle terapie standard per la distrofia muscolare di Duchenne, in linea con le raccomandazioni per la cura di tale patologia.
    6. I pazienti che fanno utilizzo cronico di glucocorticoidi dovranno aver mantenuto un dosaggio stabile per almeno 6 mesi prima dell'inclusione nello studio.
    E.4Principal exclusion criteria
    1. Any acute co-morbid condition interfering with the well-being of the patient within 7 days of enrolment (including bacterial infections, viral infectious processes, food poisoning, temperature > 37° C). Patients will be excluded from enrolment until the infection had been appropriately treated and resolved;
    2. any gastrointestinal conditions which, in the opinion of the Investigator, may interfere with the absorption of the drug or render the subjects unable to take oral medication (gastric ulcer, peptic ulcer, stomach acid, frequent diarrhoea, gastrointestinal surgery);
    3. a left ventricular ejection fraction (EF) of < 30%;
    4. forced vital capacity (FVC) < 40% of predicted;
    5. history of recurrent headache;
    6. history or presence of allergy or intolerance to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the responsible physician, contraindicates their participation;
    7. inability to take tablets, as assessed by the Investigator by the end of the screening period;
    8. previous or ongoing medical conditions, medical history, physical findings or laboratory abnormalities that could affect safety, make it unlikely that treatment and follow up will be correctly completed or impair the assessment of study results, in the judgment of the Investigator;
    9. weight of less than 13 kilograms;
    10. participation in any other investigational drug or therapy study within the previous 6 months.
    1. Qualsiasi condizione acuta di co-morbosità che possa interferire con il benessere del paziente entro 7 giorni dall'arruolamento (tra cui le infezioni batteriche , processi infettivi virali , intossicazioni alimentari , temperatura > 37 ° C) . I pazienti saranno esclusi dall'arruolamento fino a quando l'infezione viene trattata in modo appropriato e risolta;
    2. eventuali condizioni gastrointestinali , che , a giudizio dello sperimentatore, possano interferire con l' assorbimento del farmaco o rendere i soggetti non in grado di assumere farmaci per via orale ( ulcera gastrica , ulcera peptica , acidità di stomaco , diarrea frequente , chirurgia gastrointestinale );
    3. una frazione di eiezione ventricolare sinistra ( EF ) < 30 %;
    4. capacità vitale forzata ( FVC ) < 40% del valore;
    5. storia di mal di testa ricorrente;
    6. storia o presenza di allergia o intolleranza ai farmaci o ai loro componenti o a farmaci della loro classe , o una storia di droga o altra allergia che , secondo il parere del medico responsabile sia controindicata per la loro partecipazione;
    7. incapacità ad assumere le compresse durante il periodo di screening, secondo il giudizio dello Sperimentatore ;
    8. condizioni mediche precedenti o in corso, anamnesi, segni vitali o anomalie di laboratorio che, secondo il giudizio dello Sperimentatore, potrebbero compromettere la sicurezza, rendere improbabile il trattamento ed il follow-up e/o mettere in pericolo la valutazione dei risultati dello studio;
    9. peso inferiore a 13 kg;
    10. partecipazione a qualsiasi altro studio con farmaco sperimentale nei 6 mesi precedenti.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will be the mean change (%) from baseline to the end of the study in the MFM score
    L'end point primario sarà la variazione media (%) dal basale alla fine dello studio dello score MFM
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment period: 18 months
    periodo di trattamento: 18 mesi
    E.5.2Secondary end point(s)
    Secondary outcomes include other muscular measures, cardiac and pulmonary function and Quality of Life.
    Gli endpoint secondari includono altre valutazioni muscolari, cardiache, la funzione polmonare e la qualità della vita.
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 months
    18 mesi
    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 trial4
    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 concerned5
    E.8.5The trial involves multiple Member States No
    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
    Last Visit Last Subject
    Ultima visita dell'ultimo paziente
    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 months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 188
    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) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients Age ≥10 years and < 18 years
    Pazienti di età ≥10 anni e < 18 anni
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state188
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 188
    F.4.2.2In the whole clinical trial 188
    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)
    The patients, at the end of the clinical trial, will be continued to be treated according to clinical practice.
    I pazienti, al termine dello studio, continueranno il trattamento richiesto per la cura della patologia, in accordo alla pratica clinica.
    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 Decision2014-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-01
    P. End of Trial
    P.End of Trial StatusOngoing
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    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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