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    Summary
    EudraCT Number:2012-001616-33
    Sponsor's Protocol Code Number:MEM-MD-91
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-11
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-001616-33
    A.3Full title of the trial
    An Open-Label Study Of The Safety And Tolerability Of Memantine In Pediatric Patients With Autism, Asperger's Disorder, Or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
    Studio in Aperto sulla Sicurezza e Tollerabilita' di Memantina in pazienti pediatrici affetti da Autismo, Sindrome di Asperger o Disturbo Pervasivo dello Sviluppo non altrimenti specificato (Pervasive Developmental Disorder Not Otherwise Specified, PDD-NOS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Study Of The Safety And Tolerability Of Memantine In Pediatric Patients With Autism, Asperger's Disorder, Or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
    Studio in Aperto sulla Sicurezza e Tollerabilita' di Memantina in pazienti pediatrici affetti da Autismo, Sindrome di Asperger o Disturbo Pervasivo dello Sviluppo non altrimenti specificato (Pervasive Developmental Disorder Not Otherwise Specified, PDD-NOS)
    A.4.1Sponsor's protocol code numberMEM-MD-91
    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 SponsorFOREST RESEARCH INSTITUTE
    B.1.3.4CountryUnited States
    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 supportFOREST RESEARCH INSTITUTE
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles Contact Center
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressThe Alba Campus
    B.5.3.2Town/ cityRosebank, Livingston
    B.5.3.3Post codeEH54 7EG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number862 261 3634
    B.5.5Fax number862 261 3634
    B.5.6E-mailQEudraCThelpdesk@quintilescontact.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 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 nameMemantine Hydrochloride
    D.3.2Product code MRZ 2/145
    D.3.4Pharmaceutical form Prolonged-release capsule
    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 INNMEMANTINE HYDROCHLORIDE
    D.3.9.1CAS number 41100-52-1
    D.3.9.4EV Substance CodeSUB03137MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Autism or Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
    Autismo, Sindrome di Asperger o Disturbo Pervasivo dello Sviluppo non altrimenti specificato (Pervasive Developmental Disorder Not Otherwise Specified, PDD-NOS)
    E.1.1.1Medical condition in easily understood language
    Autism
    Autismo
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008520
    E.1.2Term Childhood autism
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10003484
    E.1.2Term Asperger's disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10034739
    E.1.2Term Pervasive developmental disorder NOS
    E.1.2System Organ Class 10037175 - Psychiatric 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 objective of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in the follow-up randomized withdrawal study
    L'obiettivo principale dello studio è di valutare la sicurezza e la tollerabilità di memantina in pazienti pediatrici (6-12 anni di età) affetti da autismo, sindrome di Asperger o disturbo pervasivo dello sviluppo non altrimenti specificato ( PDD-NOS) e identificare i soggetti responsivi per la partecipazione allo studio di follow-up randomizzato dopo la sospensione
    E.2.2Secondary objectives of the trial
    not applicable
    non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The parents must provide written informed consent before the patient's participation in the study. 2. Male or female outpatients 3. Age of 6-12 4. Females who are 9 years and older or who have had onset of menses must have a negative serum pregnancy test at screening 5. Meet DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) diagnostic criteria for autism, Asperger's Disorder, or PDD-NOS based on both:○ ADOS (Autism Diagnostic Observation Schedule) Modules 2 or 3 ○ ADI-R (Autism Diagnostic Interview–Revised) ADOS completed within the 6 months before Screening and ADI-R completed within the 3 months before Screening are acceptable provided that the assessments were done by a qualified rater. A copy of the scores must be available for the source file and the eCRF. 6. Normal physical examination and laboratory test results at Screening (Visit 0) or any abnormal findings must be deemed not clinically significant by the Investigator and documented 7. Normal sitting pulse rate by vital sign assessment. Any deviation from normal must be judged not clinically significant by the Investigator. Please refer to Appendix V for Normal ranges 8. Normal sitting blood pressure (BP). Any deviation from normal must be judged not clinically significant by the Investigator. 9. Ability to tolerate venipuncture procedures for blood sampling 10.knowledgeable parents capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient, and able to oversee the administration of investigational product. 11. Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study 12. Be able to speak and understand Italian sufficiently, as well as have parents who are able to speak and understand Italian sufficiently, to comprehend the nature of the study and to allow for the completion of all study assessments 13. Verbally fluent (at least three-word phrases). Must use some phrase speech if not verbally fluent 14. An SRS (Social Responsiveness Scale) total raw score > 44 for females and > 53 for males 15. An IQ in the not mentally retarded or mildly retarded range as measured by a standardized score of 50 or higher on the Kaufman Brief Intelligence Test, Version 2, or by other standard IQ test used for non- English speakers and in the countries outside the United States and Canada where the study is being conducted, at Screening (Visit 0)
    1.I genitori devono fornire un consenso informato scritto prima della partecipazione del paziente nello studio. 2.Pazienti ambulatoriali di sesso maschile o femminile. 3.Età 6-12 anni. 4.Le femmine che hanno 9 anni o che hanno avuto inizio delle mestruazioni devono avere un test di gravidanza sul siero negativo allo screening 5.Soddisfare i criteri diagnostici di autismo, sindrome di Asperger o PDD-NOS basati sul Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (Manuale diagnostico e statistico dei disturbi mentali, Quarta edizione, Revisione del testo) (DSM-IV-TR)sulla base di: ADOS (programma per l’osservazione diagnostica dell’autismo)moduli 2 o 3 e ADI-R (intervista diagnostica sull’autismo - rivista). ADOS completata entro i 6 mesi prima dello Screening e ADI-R completata entro i 3 mesi prima dello Screening sono accettabili a condizione che le valutazioni siano state fatte da un rater qualificato. Una copia dei ounteggi deve essere disponibile per la cartella clinica e la eCRF. 6.Esame obiettivo normale e risultati dei test di laboratorio allo screening (visita 0) o eventuali risultati anomali devono essere considerati non clinicamente significativi dallo sperimentatorei e documentati. 7. Normale frequenza cardiaca a riposo dalla valutazione dei segni vitali. Qualsiasi deviazione dalla norma deve essere giudicata clinicamente non significativa dallo sperimentatore. Fare riferimento all'Appendice V per gli intervalli di normalità. 8. Normale pressione sanguigna ortostatica. Qualsiasi deviazione dalla norma deve essere giudicata clinicamente non significativa dallo sperimentatore. 9. Capacità di tollerare le procedure di prelievo di sangue 10. Genitori in grado di fornire informazioni affidabili sulle condizioni del paziente, in grado di partecipare a tutte le visite in ospedale con il paziente, e in grado di controllare la somministrazione del prodotto in sperimentazione. 11. Avere una famiglia che è sufficientemente organizzata e stabile per garantire un adeguato controllo di sicurezza e assistenza continua per le visite ambulatoriali per tutta la durata dello studio 12. Essere in grado di parlare e capire l'italiano a sufficienza,così come avere dei genitori in grado di parlare e capire l'italiano a sufficienza, per comprendere la natura dello studio e per consentire il completamento di tutte le valutazioni di studio 13. Parlata fluente (almeno frasi di tre parole). È necessario utilizzare un discorso con frasi se non c'è una parlata fluente.14.SRS (Scala di Responsività Sociale) con un punteggio totale grezzo&gt; 44 per le femmine e&gt; 53 per i maschi. 15. Un QI nel range del non ritardo mentale o del lieve ritardo misurato mediante un punteggio standardizzato di 50 o superiore secondo il test di intelligenza Kaufman Brief, versione 2, o da altri test QI standard utilizzati per chi non parla inglese e nei paesi al di fuori degli Stati Uniti e Canada, dove lo studio viene condotto, al momento dello screening (visita 0)
    E.4Principal exclusion criteria
    1. History of premature birth (before 35 weeks gestational age or weight of < 5 lb at birth) 2. History of hypersensitivity reaction to memantine, dextromethorphan, amantadine, or any other NMDA receptor antagonists 3. Having any primary psychiatric (Axis I) diagnosis other than autism, Asperger's Disorder, and PDD-NOS 4. Meeting DSM-IV-TR criteria for bipolar I disorder, psychotic disorder not otherwise specified, posttraumatic stress disorder, schizophrenia, or major depressive disorder within the past 6 months 5. An ABC (Aberrant Behavior Checklist) Irritability subscale (ABC-I) score ≥ 17 at Screening (Visit 0) 6. Significant risk of suicidality based on the investigator judgment, ABCI, or if appropriate, as indicated by a response of ''yes'' to questions 3, 4, or 5 in the suicidal ideation section of the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 0) or any suicidal behavior within the past 6 months. 7. Taking, or having taken NMDA antagonists (eg, amantadine, ketamine, dextromethorphan) or any other excluded concomitant medications (Appendix III) within five half-lives or 4 weeks of Screening (Visit 0), whichever is shorter. 8. Medical history of neurological disease including, but not limited to, movement disorder; Tourette syndrome; tuberous sclerosis; fragile X syndrome; velocardiofacial syndrome; chromosome 15q duplication syndrome; Angelman syndrome; active epilepsy/seizure disorder (defined as seizure activity within 5 years of screening (Visit 0) except simple febrile seizures; known abnormal computed tomography/magnetic resonance imaging of the brain; or a structural lesion of the brain 9. Medical conditions that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well-being. Such conditions include, but are not limited to, evidence or history of malignancy or any significant hematologic, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease. If there is a history of such disease but the condition has been stable for more than 1 year and is judged by the Investigator not to interfere with the patient's participation in the study, the patient may be included, with the documented approval of the Study Physician 10. Clinically significant ECG abnormalities. Any deviation from normal must be judged not clinically significant by the Investigator. Please refer to Appendix V for out of normal ranges ECG values and findings 11. Participation in any other clinical investigation using an experimental drug or requiring repeated blood draws within 30 days of the start of this study or participation in a blood donation program within the past 60 days 12. Treatment with memantine or participation in an investigational study of memantine within 90 days of Screening (Visit 0) 13. Female patients of child-bearing potential who are not using or not willing to use a conventional method of contraception approved by the PI. Abstinence is an acceptable method of contraception 14. Patients who, in the Investigator's and/or Sponsor's opinion, might not be suitable for te study 15. Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its affiliates or partners, or the study center
    1.Storia di nascita prematura (prima di 35 settimane di gravidanza o il peso di &lt;5 lb al momento della nascita).2. Storia di reazione di ipersensibilità ad memantina, destrometorfano, amantadina, o qualsiasi altro antagonista del recettore NMDA 3. Pazienti con diagnosi di qualsiasi disturbo psichiatrico primario (Asse I) diverso da autismo, disturbo di Asperger e PDD-NOS 4. Paziente che soddisfa i criteri DSM-IV-TR per disturbo bipolare I, disturbo psicotico non altrimenti specificato, disturbo da stress post-traumatico, schizofrenia o disturbo depressivo maggiore negli ultimi 6 mesi 5.Sottoscala ABC(Aberrant Behavior Checklist) di irritabilità (ABC-I) con punteggio≥ 17 allo screening (visita 0) 6. Significativo rischio di suicidio in base al giudizio dello sperimentatore, ABC-I, o, se del caso, come indicato dalla risposta SI' alle domande 3, 4 o 5 nella sezione di ideazione suicidaria della Columbia-Suicide Severity Rating Scale dei bambini( C-SSRS) al momento dello screening (visita 0) o di comportamenti suicidi negli ultimi 6 mesi. 7. Assumere o aver assunto antagonisti NMDA (ad esempio amantadina, ketamina, destrometorfano) o qualsiasi altro farmaco concomitante proibito (appendice III), entro cinque emivite o 4 settimane di screening (visita 0), quale accada prima. 8. Storia medica di malattia neurologica tra cui, ma non solo, disturbi del movimento, sindrome di Tourette,sclerosi tuberosa, sindrome dell'X fragile,sindrome di velocardiofacciale, sindrome della duplicazione del cromosoma 15q; sindrome di Angelman,epilessia attiva/crisi convulsive (definiti come attività convulsiva entro 5 anni dallo screening (visita 0), tranne convulsioni febbrili semplici;tomografia computerizzata/risonanza magnetica del cervello anomala riconosciuta, o una lesione strutturale del cervello.9. condizioni mediche che potrebbero interferire con lo svolgimento dello studio,confondere l'interpretazione dei risultati dello studio,o mettere in pericolo il benessere del paziente. Tali condizioni includono, ma non sono limitati a, prove o storia di tumore maligno o di qualsiasi patologia ematologica, endocrina, cardiovascolare (incluso qualsiasi disturbo del ritmo), respiratoria, renale, epatica o gastrointestinale significativa.Se c'è una storia clinica di tali malattie, ma la condizione è stabile per più di 1 anno ed è giudicato dallo sperimentatore non interferire con la partecipazione del paziente nello studio, il paziente può essere incluso, con l'approvazione documentata del Medico dello Studio. 11.Anomalie dell'ECG clinicamente significative. Qualsiasi deviazione dalla norma deve essere giudicata clinicamente non significativa dallo sperimentatore. Fare riferimento all'Appendice V per i valori ed i risultati di ECG fuori dal range di normalità. 12.La partecipazione a qualsiasi altra indagine clinica con un farmaco sperimentale o che richieda prelievi di sangue ripetuti entro 30 giorni dall'inizio di questo studio o la partecipazione ad un programma di donazione di sangue negli ultimi 60 giorni 12.Trattamento con memantina o la partecipazione a uno studio sperimentale con memantina entro 90 giorni dallo screening (visita 0) 13. pazienti di sesso femminile in età fertile che non usano o non vogliono utilizzare un metodo convenzionale di contraccezione approvato dallo sperimentatore. L'astinenza è un metodo accettabile di contraccezione 14. I pazienti che, a giudizio dello sperimentatore e/o dello Sponsor, potrebbero non essere adatti per lo studio 15. Dipendente o parente stretto di un dipendente di Forest Laboratories, Inc., o di una delle sue affiliate o partner, o del centro
    E.5 End points
    E.5.1Primary end point(s)
    1) Complete at least 12 weeks of exposure to investigational product and 2) Meet the responder criterion at two consecutive visits separated by at least two weeks. A patient will be considered a responder if he or she presented at least 10 points improvement (reduction in score) in SRS relative to the Visit 1 total raw score.
    1) Completare almeno 12 settimane di esposizione al prodotto in studio 2) Soddisfare il criterio di responsività in due visite consecutive separate da almeno due settimane. Un paziente sarà considerato rispondente se lui o lei ha presentato un miglioramento di almeno 10 punti (riduzione del punteggio) in SRS rispetto al punteggio totale grezzo della Visita 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients meeting the confirmed responder criteria any time at or after Visit 5 (end of Week 12) will be expected to transition to a follow-up randomized withdrawal study (MEM-MD-68). SRS will be administered at Visits 0, 1, 4A, 5, 5A, 6, 6A, 7, 7A, 8, and confirmatory visits.
    I pazienti che soddisfano i criteri di responsività confermati in qualsiasi momento o dopo la visita di 5 (fine della settimana 12) dovranno passare ad uno studio di sospensione di follow-up randomizzato(MEM-MD-68). SRS sarà valutato alle visite 0, 1, 4A, 5A, 5, 6, 6 bis, 7, 7A, 8, e alle visite di conferma.
    E.5.2Secondary end point(s)
    No secondary objectives
    Non ci sono obiettivi secondari
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable as no secondary objectives
    Non applicabile in quanto non ci sono obiettivi secondari
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial0
    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 EEA31
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Colombia
    Korea, Republic of
    Mexico
    New Zealand
    Philippines
    Russian Federation
    Singapore
    South Africa
    Taiwan
    Ukraine
    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
    The study will be terminated when the required number of patients transition into the follow-up randomized study. Patients active at the time of end of study will perform Visit 8 and will be eligible to continue in a follow-up open-label study. Forest, reserves the right to terminate the study in its entirety or at a specific study center before study comp
    Lo studio terminerà quando il numero richiesto di pazienti passerà allo studio di FU randomizzato.Pazienti attivi alla fine dello studio faranno la Visita 8 appena possibile e potranno entrare nello studio di FU in aperto.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months13
    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 Yes
    F.1.1Number of subjects for this age range: 192
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 164
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 28
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The patient's parents will provide informed consent.
    I genitori del bambino firmeranno il consenso informato.
    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 96
    F.4.2.2In the whole clinical trial 192
    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)
    Patients meeting the confirmed responder criteria any time at or after Visit 5 will be expected to transition to a follow-up randomized study MEM-MD-68.They will be randomized to one of three double-blind treatment arms(full or reduced dose or placebo).Patients not meeting the SRS responder criteria will continue in this study until the Final Visit.Patients who are non-responders at the end of the study may be eligible to transition to a follow-up open-label study
    yI pazienti che soddisfano i criteri di risposta confermati in qualsiasi momento o dopo Visita 5 dovranno passare allo studio MEM-MD-68 di follow-up randomizzato.Saranno randomizzati ad uno dei tre bracci di trattamento in doppio cieco(dose piena o ridotta o placebo).I pazienti che non soddisfano i criteri di risposta SRS continueranno in questo studio fino alla visita finale.I pazienti non-responder alla fine dello studio possono essere elegibili a passare nello studio di FU in apert
    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 Decision2012-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-09
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