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    Summary
    EudraCT Number:2012-001616-33
    Sponsor's Protocol Code Number:MEM-MD-91
    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:2012-07-26
    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 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)
    ESTUDIO ABIERTO DE SEGURIDAD Y TOLERABILIDAD DE MEMANTINA EN
    PACIENTES PEDIÁTRICOS CON AUTISMO, SÍNDROME DE ASPERGER O
    TRASTORNO GENERALIZADO DEL DESARROLLO NO ESPECIFICADO (TGDNE)
    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)
    ESTUDIO ABIERTO DE SEGURIDAD Y TOLERABILIDAD DE MEMANTINA EN
    PACIENTES PEDIÁTRICOS CON AUTISMO, SÍNDROME DE ASPERGER O
    TRASTORNO GENERALIZADO DEL DESARROLLO NO ESPECIFICADO (TGDNE)
    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, Inc.
    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 United States
    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.5.6E-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 o síndrome de Asperger o trastorno general del desarrollo no
    especificado (TGD-NE)
    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 10029205 - Nervous system disorders
    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
    Evaluar la seguridad y la tolerabilidad de memantina en pacientes
    pediátricos (6-12 años) con autismo, síndrome de Asperger o trastorno
    generalizado del desarrollo no especificado (TGD-NE) e identificar a los
    pacientes con respuesta para participar en el estudio de seguimiento
    aleatorizado de la retirada
    E.2.2Secondary objectives of the trial
    not applicable
    na
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in the study, patients must meet the following criteria:
    1. Provide written informed assent, when developmentally appropriate, to participate in the study before conduct of any study-specific procedures. The parent/guardian/LAR must provide written informed consent before the patient?s participation in the study. A separate written informed consent for the caregiver must also be obtained before the conduct of any study specific procedures.
    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. A knowledgeable caregiver 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. Every effort should be made to maintain the same caregiver throughout the study
    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 English sufficiently (or their native language if this can be accommodated by the site), as well as have a caregiver and parent/guardian/LAR who is able to speak and understand English sufficiently (or their native language if this can be accommodated by the site), 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. Otorgar su asentimiento informado por escrito, en caso de que tenga
    un desarrollo suficiente, para participar en el estudio antes de realizar
    ningún procedimiento específico del estudio. El
    progenitor/tutor/representante legal deberá otorgar su consentimiento
    informado por escrito antes de la participación del paciente en el
    estudio. También deberá obtenerse el consentimiento informado por escrito del cuidador antes de realizar ningún procedimiento específico
    del estudio.
    2. Pacientes ambulatorios de uno u otro sexo.
    3. Edad de 6-12 años.
    4. Las niñas de 9 años o más de edad o que ya hayan comenzado con la
    menstruación deberán tener una prueba de embarazo en suero negativa
    en la selección.
    5. Cumplir los criterios diagnósticos de autismo, síndrome de Asperger o
    TGD-NO del DSM-IV-TR, basándose en:
    o Escala ADOS, módulos 2 o 3.
    o Escala ADI-R.
    La escala ADOS cumplimentada en los 6 meses previos a la selección y la
    escala ADI-R cumplimentada en los 3 meses previos a la selección serán
    aceptables siempre que las evaluaciones hayan sido realizadas por un
    evaluador cualificado. Una copia de las puntuaciones deberá encontrarse
    disponible para el archivo original y el CRDe.
    6. Exploración física y resultados analíticos normales en la selección
    (visita 0) o presencia de anomalías que el investigador considera sin
    importancia clínica y quedan documentadas.
    7. Frecuencia cardíaca en sedestación normal al evaluar las constantes
    vitales. Toda desviación de la normalidad deberá ser considerada sin
    importancia clínica por el investigador. Consulte los intervalos normales
    en el apéndice V.
    8. Presión arterial (PA) en sedestación normal. Toda desviación de la
    normalidad deberá ser considerada sin importancia clínica por el
    investigador. Consulte los intervalos normales en el apéndice V.
    9. Capacidad para tolerar los procedimientos de punción venosa para
    obtener muestras de sangre.
    10. Un cuidador informado capaz de facilitar información fiable sobre el
    estado del paciente, de acudir a todas las visitas al centro con el
    paciente y de supervisar la administración del producto en investigación.
    Se hará todo lo posible por mantener el mismo cuidador durante todo el
    estudio.
    11. Disponer de una familia suficientemente organizada y estable para
    garantizar una vigilancia adecuada de la seguridad y una asistencia
    continua a las visitas al centro durante el estudio.
    12. Capacidad de hablar y entender suficientemente el inglés (o su
    idioma cuando esto sea viable en el centro), además de contar con un
    cuidador y un progenitor/tutor/representante legal capaz de hablar y
    entender suficientemente el inglés (o su idioma cuando esto sea viable
    en el centro), para comprender la naturaleza del estudio y permitir la
    realización de todas las evaluaciones del estudio.
    13. Fluidez verbal (frases con al menos de tres palabras). Debe utilizar
    un habla con algunas frases en caso de que no tenga fluidez verbal.
    14. Puntuación bruta total SRS > 44 en las niñas y > 53 en los niños.
    15. Un CI situado en el intervalo de ausencia de retraso mental o
    retraso leve, según lo determinado mediante una puntuación
    normalizada de 50 o más en la prueba breve de inteligencia de Kaufman,
    versión 2, u otra prueba de CI habitual utilizada para personas no
    angloparlantes y en países distintos de Estados Unidos y Canadá donde
    se esté realizando el estudio, en la selección (visita 0).
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will not be eligible to participate in the
    study:
    1. Have enrolled in Study MEM-MD-57A
    2. History of premature birth (before 35 weeks gestational age or weight of < 5 lb at birth)
    3. History of hypersensitivity reaction to memantine, dextromethorphan, amantadine, or any other NMDA receptor antagonists
    4. Having any primary psychiatric (Axis I) diagnosis other than autism, Asperger?s Disorder, and PDD-NOS
    5. 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
    6. An ABC (Aberrant Behavior Checklist) Irritability subscale (ABC-I) score ? 17 at Screening (Visit 0)
    7. Significant risk of suicidality based on the investigator judgment, ABC-I, 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.
    8. 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.
    9. 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
    10. 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
    11. 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
    12. 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
    13. Treatment with memantine or participation in an investigational study of memantine within 90 days of Screening (Visit 0)
    14. 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
    15. Patients who, in the Investigator?s and/or Sponsor?s opinion, might not be suitable for te study
    16. Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its affiliates or partners, or the study center
    1. Haber sido incluido en el estudio MEM-MD-57A.
    2. Antecedentes de parto prematuro (antes de las 35 semanas de edad
    gestacional o peso < 2,25 kg al nacer).
    3. Antecedentes de reacción de hipersensibilidad a memantina,dextrometorfano, amantadina u otros antagonistas de los receptores de
    NMDA.
    4. Tener un diagnóstico psiquiátrico principal (eje I) diferente de
    autismo, síndrome de Asperger y TGD-NE.
    5. Cumplir los criterios de trastorno bipolar I, trastorno psicótico no
    especificado, trastorno por estrés postraumático, esquizofrenia o
    trastorno depresivo mayor del DSM-IV-TR en los 6 meses precedentes.
    6. Puntuación en la subescala de irritabilidad de la escala ABC (ABC-I) ?
    17 en la selección (visita 0).
    7. Riesgo significativo de suicidio según el criterio del investigador, la
    escala ABC-I o, si procede, según lo indicado por una respuesta "sí" a las
    preguntas 3, 4 o 5 en el apartado de ideación suicida de la Escala de
    valoración del riesgo de suicidio de la Universidad de Columbia (C-SSRS)
    para niños en la selección (visita 0) o cualquier comportamiento suicida
    en los 6 meses precedentes.
    8. Tomar o haber tomado antagonistas del NMDA (por ejemplo,
    amantadina, ketamina o dextrometorfano) u otros medicamentos
    concomitantes excluidos (apéndice III) en un período correspondiente a
    cinco semividas o 4 semanas antes de la selección (visita 0), lo que sea
    más corto.
    9. Antecedentes de una enfermedad neurológica, entre otras, trastornos
    del movimiento, síndrome de Gilles de la Tourette, esclerosis tuberosa,
    síndrome del cromosoma X frágil, síndrome velocardiofacial, síndrome
    de duplicación del cromosoma 15q, síndrome de Angelman,
    epilepsia/trastorno convulsivo activo (definido como actividad
    convulsiva en los 5 años anteriores a la selección (visita 0) excepto
    convulsiones febriles simples, tomografía computarizada/resonancia
    magnética anormal conocida del cerebro o lesión estructural del cerebro.
    10. Trastornos médicos que pudieran interferir en la realización del
    estudio, confundir la interpretación de los resultados del estudio o poner
    en peligro el bienestar del paciente. Estos trastornos comprenden, entre
    otros, datos o antecedentes de neoplasia maligna o cualquier
    enfermedad hematológica, endocrina, cardiovascular (incluidos
    trastornos del ritmo), respiratoria, renal, hepática o digestiva
    importante. Cuando haya antecedentes de una enfermedad de este tipo,
    pero la situación haya permanecido estable durante más de un año y el
    investigador considere que no interferirá en la participación del paciente
    en el estudio, éste podrá ser incluido con la aprobación documentada del
    médico del estudio.
    11. Anomalías electrocardiográficas clínicamente importantes. Toda
    desviación de la normalidad deberá ser considerada sin importancia
    clínica por el investigador. Consulte en el apéndice V los valores y
    resultados del ECG fuera de los intervalos normales.
    12. Participación en otro estudio clínico con un fármaco experimental o
    necesidad de extracciones repetidas de sangre en los 30 días anteriores
    al comienzo del estudio o participación en un programa de donación de
    sangre en los 60 días precedentes.
    13. Tratamiento con memantina o participación en un estudio de
    investigación de memantina en los 90 días anteriores a la selección
    (visita 0).
    14. Niñas en edad fértil que no estén utilizando o no se muestren
    dispuestas a utilizar un método anticonceptivo convencional aprobado
    por el IP. La abstinencia será un método anticonceptivo aceptable.
    15. Pacientes que, a criterio del promotor o investigador, podrían no ser
    aptos para el estudio.
    16. Empleados y familiares directos de empleados de Forest
    Laboratories, Inc., de cualquiera de sus filiales o socios o del centro de
    estudio.
    Toda la información diagnóstica (por ejemplo, escalas diagnósticas
    utilizadas o antecedentes médicosHistoria clínica) deberá quedar documentada en los documentos originales y deberá dar lugar a un
    diagnóstico de autismo, síndrome de Asperger o TGD-NE.
    Todas las excepciones a los criterios de inclusión y exclusión se
    considerarán caso por caso y tendrán que quedar documentadas en los
    documentos originales y el CRDe. Todas las excepciones precisarán la
    aprobación del promotor antes de que el paciente sea incluido en el
    estudio. En relación con la exploración física, evaluaciones analíticas,
    constantes vitales y hallazgos del ECG, todas las anomalías deberán ser
    consideradas sin importancia clínica por el investigador y quedar
    documentadas como tales en los documentos originales y el CRDe.
    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) Han completado al menos 12 semanas de exposición al producto en
    investigación y
    2) Cumplen el criterio de respuesta, de pacientes con respuesta en dos
    visitas consecutivas separadas por al menos dos semanas. Se
    considerará que un paciente ha tenido respuesta cuando presente una
    mejoría de al menos 10 puntos (reducción de la puntuación) en la escala
    SRS en relación con la puntuación bruta total de la 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.
    Cabe esperar que los pacientes que cumplan estos criterios en cualquier
    momento a partir de la visita 5 se incorporen a un estudio de de
    seguimiento aleatorizado, de la retirada (MEM-MD-68). Los pacientes
    que no cumplan los criterios anteriores seguirán participando en este
    estudio hasta la visita final (visita 8).
    E.5.2Secondary end point(s)
    No secondary objectives
    No hay objetivos secundarios
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable as no secondary objectives
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 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
    Belgium
    Colombia
    Denmark
    Finland
    France
    Germany
    Hungary
    Iceland
    Ireland
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    New Zealand
    Norway
    Philippines
    Poland
    Russian Federation
    Serbia
    Singapore
    South Africa
    Spain
    Sweden
    Taiwan
    Thailand
    Ukraine
    United Kingdom
    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
    This study will be terminated when the required number of patients transition into the follow-up randomized withdrawal study. Patients active at the time of study termination will return to the site for final evaluations (Visit 8/ET) at the earliest opportunity and will be considered study completers, 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 completion.
    Este estudio finalizará cuando se alcance el nº exigido de pacientes q. se incorporen al estudio de seguimiento aleatorizado de retirada. Los pacientes activos en la finalización del estudio deberán acudir al centro para someterse a las evaluaciones finales (visita 8/RP), se les considerará pacientes completadoss y serán aptos para incorporarse al estudio abierto de seguimiento.
    Forest Research Institute Inc., se reserva el derecho a poner fin al estudio antes de su finalización.
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months13
    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 parent/guardian/LAR will provide informed consent. When determined the child is capable of assent, child assent will also be obtained.
    Los padres del paciente, su cuidador o tutores legales aportarán el
    consentimiento informado. Si el niño tiene la capacidad de consentir,
    también se aportará un consentimiento para niños
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    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 withdrawal 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 MEM-MD-69.
    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 Medicines for Children Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-09
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