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    Summary
    EudraCT Number:2014-002246-41
    Sponsor's Protocol Code Number:BP29420
    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:2015-03-03
    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 number2014-002246-41
    A.3Full title of the trial
    A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO6885247 FOLLOWING 12 WEEKS OF TREATMENT IN ADULT AND PEDIATRIC PATIENTS WITH SPINAL MUSCULAR ATROPHY (MOONFISH)
    Estudio multicéntrico, aleatorizado, doble ciego controlado con placebo, de dosis múltiple, para evaluar la seguridad, tolerancia, farmacocinética y farmacodinámica, tras 12 semanas de tratamiento con RO6885247, en pacientes adultos y pediátricos con atrofia muscular espinal
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of RO6885247 in Adult and Pediatric Patients with Spinal Muscular Atrophy (MOONFISH)
    Estudio de RO6885247 en adultos y pacientes pedíatricos con atrofia muscular espiral (MOONFISH)
    A.3.2Name or abbreviated title of the trial where available
    MOONFISH
    A.4.1Sponsor's protocol code numberBP29420
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02240355
    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 SponsorRoche Farma S.A., en nombre de F. Hoffmann-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34 91 325 73 00
    B.5.6E-mailglobal.rochegenentechtrials@roche.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.3.2Product code RO6885247/F03
    D.3.4Pharmaceutical form Powder for oral solution
    D.3.4.1Specific paediatric formulation Yes
    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 INNn.a.
    D.3.9.1CAS number 1449598-06-4
    D.3.9.2Current sponsor codeRO6885247
    D.3.9.3Other descriptive namen.a.
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 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.3.2Product code RO6885247/F02
    D.3.4Pharmaceutical form Powder for oral solution
    D.3.4.1Specific paediatric formulation Yes
    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 INNn.a.
    D.3.9.1CAS number 1449598-06-4
    D.3.9.2Current sponsor codeRO6885247
    D.3.9.3Other descriptive namen.a.
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboOral solution
    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
    Spinal Muscular Atrophy
    Atrofia muscular espinal
    E.1.1.1Medical condition in easily understood language
    Spinal Muscular Atrophy, a genetic progressive neuromuscular disease characterized by profound weakness and muscle atrophy that is the leading genetic cause of death in babies and toddlers.
    Atrofia muscular espinal, enfermedad genética neuromuscular progresiva caracterizada por debilidad profunda y atrofia muscular que es la principal causa genética de muertes en bebés y niños.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10041582
    E.1.2Term Spinal muscular atrophy
    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 evaluate the safety and tolerability of 12 weeks treatment with RO6885247 in adult and pediatric patients with spinal muscular atrophy (SMA)
    Evaluar la seguridad y la tolerancia de un tratamiento de 12 semanas con RO6885247 en pacientes adultos y pediátricos con atrofia muscular espinal (AME)
    E.2.2Secondary objectives of the trial
    Pharmacokinetics
    - To investigate the multiple-dose pharmacokinetics (PK) of RO6885247 and its metabolite(s), if appropriate
    - To gain preliminary information on the potential effect of food on the PK of RO6885247

    Pharmacodynamics
    - To investigate pharmacodynamic (PD) effects of RO6885247 as assessed by Survival of Motor Neuron 2 (SMN2) splicing modification and increase in SMN protein
    - To investigate the PK/PD relationship of RO6885247 by PK/PD modeling (PD to include SMN2 messenger RNA [mRNA] and SMN protein)
    - To investigate the effect of 12 weeks of treatment with RO6885247 on muscle electrophysiology as assessed by Compound Muscle Action Potential (CMAP) (optional for patients aged 7 months or below)
    - To investigate the effect of 12 weeks of treatment with RO6885247 on Electrical Impedance Myography (EIM) (optional)
    Farmacocinética:
    - Investigar la farmacocinética (FC) de dosis múltiples de RO6885247 y sus metabolitos, si procede.
    - Obtener información preliminar sobre el efecto potencial de los alimentos sobre la farmacocinética de RO6885247.

    Farmacodinámica:
    - Investigar los efectos de farmacodinámica (FD) de RO6885247 de acuerdo con la evaluación de la modificación del proceso de corte de SMN2 y el aumento de la proteína SMN.
    - Investigar la relación FC/FD de RO6885247 mediante modelos de FC/FD (FD para incluir ARNm del gen SMN2 y la proteína SMN).
    - Investigar el efecto de 12 semanas de tratamiento con RO6885247 sobre la electrofisiología muscular según la evaluación del potencial de acción muscular compuesto (PAMC) (opcional para pacientes de 7 meses o menores).
    - Investigar el efecto de 12 semanas de tratamiento con RO6885247 sobre la miografía de impedancia eléctrica (EIM).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Males and females aged below 7 months (inclusive) or 2 to 55 years (inclusive)
    - Confirmed diagnosis of 5q-autosomal recessive SMA (Types 1 to 3). For patients aged 7 months or below, clinical symptoms attributable to type 1 SMA and two SMN2 copies.
    - Able and willing to provide informed consent and to comply with the study protocol. Alternatively, a legally authorized representative must be able to consent for the patient and assent must be given by the patient wherever possible.
    - Female patients of childbearing potential and male patients with a female partner of childbearing potential must agree with the required contraceptive methods as defined per protocol.
    - Pacientes de ambos sexos, de entre 2 y 55 años (incluidos) o de hasta 7 meses de edad.
    - Diagnóstico confirmado de AME autosómica recesiva ligada al cromosoma 5q. Para pacientes de hasta 7 meses de edad o menores, síntomas clínicos atribuibles a AME de tipo 1 y 2 copias del gen SMN2.
    - Capaz y dispuesto a otorgar su consentimiento y cumplir el protocolo del estudio. Como alternativa, un representante legalmente autorizado debe dar su consentimiento en nombre del paciente y se debe dar el asentimiento por el paciente siempre que sea posible.
    - Las mujeres en edad fértil y pacientes varones con pareja en edad fértil deben comprometerse deben comprometerse a utilizar métodos anticonceptivos tal y como se especifica en el protocolo.
    E.4Principal exclusion criteria
    - Concomitant or previous participation in any investigational drug or device study within 90 days prior to screening
    - Concomitant or previous participation in a SMN2-targeting antisense oligonucleotide study within 12 months prior to screening
    - Concomitant or previous participation at any time in a gene therapy study
    - History of cell therapy
    - Hospitalization for pulmonary event within the last 2 months or planned at the time of screening (for patients aged 2-55 years)
    - Surgery for scoliosis in the last 6 months from screening or planned within 6 months from screening
    - Unstable gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease
    - Clinically relevant ECG abnormalities at screening or baseline; personal or family history (first degree relatives) of congenital long QT syndrome
    - Clinically significant abnormalities in laboratory test results at screening
    - Any concomitant disease or condition that could interfere with the conduct of the study, or pose an unacceptable risk to the patient in this study
    - Use of prohibited medications as per protocol within 90 days prior to randomization. Patients who are on inhaled corticosteroids, administered either through a nebulizer or an inhaler, are allowed.
    - Recently initiated treatment (within <6 months prior to randomization) with oral salbutamol or another beta2-adrenergic agonist taken orally is not allowed. Patients who have been on oral salbutamol (or another beta2-adrenergic agonist) for at least 6 months before randomization are allowed. Use of inhaled beta2-adrenergic agonists is allowed.
    - Ascertained or presumptive hypersensitivity (e.g. anaphylactic reaction) to RO6885247 or to the constituents of its formulation
    - Patients aged 7 months or below requiring invasive ventilation, tracheotomy, day-time non-invasive ventilation or patients with nocturnal hypoxemia; patients having had severe pneumonia and have not fully recovered their pulmonary function at the time of screening; patients with contractures or hip subluxation/dislocation at birth; patients with non-SMA related morbidities.
    - Participación simultánea o anterior en cualquier estudio de investigación sobre fármacos o dispositivos durante los 90 días anteriores a la selección.
    - Participación simultánea o anterior en un estudio sobre oligonucleótidos antisentido dirigidos a SM/V2 durante los 12 meses anteriores a la selección.
    - Participación simultánea o previa en cualquier fase de un estudio sobre terapia génica.
    - Antecedentes de cualquier tipo de terapia celular.
    - Hospitalización por episodio pulmonar durante los últimos 2 meses o prevista en el momento de la selección (para pacientes de 2 a 55 años).
    - Cirugía de escoliosis realizada o planificada en los 6 meses posteriores a la selección.
    - Enfermedad inestable en el sistema gastrointestinal, renal, hepático, cardiovascular o endocrino.
    - Anomalías ECG de importancia clínica en el momento de la selección o en el momento basal; historial personal o familiar (familiares consanguíneos) de síndrome de QT largo congénito.
    - Anomalías de importancia clínica en resultados de análisis durante selección.
    - Cualquier tratamiento o enfermedad o trastorno concomitante que pudiera interferir en el desarrollo del estudio, o que pudiera suponer un riesgo inaceptable para el paciente en este estudio.
    - Uso de medicamentes prohibidos por protocolo en los 90 días anteriores a la aleatorización. Se permitirá pacientes que tomen corticoesteroides inhalados, ya sea mediante nebulizador o inhalador.
    - No se permiten tratamientos recientemente iniciados (dentro de los 6 meses anteriores a la aleatorización) con salbutamol oral u otro agonista ?2 adrenérgico administrado por vía oral. Se permitirá la participación de aquellos pacientes que hayan tomado salbutamol oral (u otro agonista ?2 adrenérgico) dentro de los 6 meses anteriores a la aleatorización. Se permite el uso de agonistas ?2 adrenérgicos inhalados (por ejemplo, para el tratamiento del asma).
    - Hipersensibilidad demostrada o posible (por ejemplo, reacción anafiláctica) al RO6885247 o a los componentes de su formulación
    - Para pacientes de hasta 7 meses de edad en el momento de la selección:
    Pacientes que requieren ventilación invasiva o traqueostomía; ventilación no invasiva durante el día o que sufren hipoxemia nocturna (saturación de O2 < 93%); pacientes con neumonía grave que no han recuperado por completo su función pulmonar en el momento de la selección; pacientes con contracturas y/o dislocación o subluxación de cadera al nacer; pacientes con presencia de morbilidades no relacionadas con la AME.
    E.5 End points
    E.5.1Primary end point(s)
    Safety: Incidence of adverse events (AEs)
    Seguridad:
    Incidencia de acontecimientos adversos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 20 weeks
    Hasta 20 semanas.
    E.5.2Secondary end point(s)
    1. Pharmacokinetics: RO6885247 plasma concentrations
    2. Pharmacokinetics: RO6885247 exposure, area under the concentration-time curve (AUC-tau, over the 24-hour dosing interval)
    3. Pharmacodynamics: SMN protein levels in blood
    4. Effect of RO6885247 on muscle electrophysiology, as assessed by Compound Muscle Action Potential (CMAP)
    5. Effect of RO6885247 on Electrical Impedance Myography
    6. Pharmacodynamics: In vivo splicing modification of SMN2 mRNA in blood
    1. Farmacocinetica: vonventraciones en plasma de RO6885247 .
    2 Farmacocinetica: RO6885247 AUCT (durante un intervalo de administración de 24 horas).
    3. Farmacocinética: niveles de la proteína SMN en sangre.
    4. Efecto de RO6885247 en la electrofisiología del músculo, evualuado por PAMC.
    5. Efecto de RO6885247 en EIM.
    6. Farmacocinética: Modificación de corte in vivo de ARNm del gen SMN2 en sangre.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to 16 weeks for patients aged 2-55 years-old; up to 20 weeks for patients aged 7 months or below (at screening)
    2. Up to 12 weeks for patients aged 2-55 years-old; up to 20 weeks for patients aged 7 months or below (at screening)
    3-6: Up to 20 weeks
    1. Hasta 16 semanas para pacientes de - a 55 años de edad; hasta 20 semanas para pacientes de hasta 7 meses de edad (en selección).
    2. Hasta 12 semanas para pacientes de 2 a 55 años de edad; hasta 20 semanas para pacientes de hasta 7 meses de edad (en selección).
    3-6. Hasta 20 semanas.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, clinical genotyping
    Tolerancia, genotipado clínico.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Ib, multiple dose study
    Ib, estudio de dosis múltiple.
    E.7.2Therapeutic exploratory (Phase II) No
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    France
    Italy
    Netherlands
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The date when the last patient?s last visit (LPLV) occurs
    El estudio se considera finalizado con la última visita del último paciente (UVUP).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 52
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 16
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 24
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    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
    children (see above)
    Niños (ver más arriba)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 64
    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)
    Should PD proof of mechanism on SMN2 mRNA be shown in this study and no safety concerns emerge, the Sponsor envisages providing access to RO6885247 to SMA patients enrolled in this study:
    - without any treatment interruption for infant patients with type 1 SMA
    - after the conclusion of this study and after completion of the nonclinical toxicology studies necessary to support chronic treatment in humans for patients aged 2-55 years.

    Please refer to Protocol section 4.3.5 for further details.
    Si se demostrara en este estudio el mecanismo de acción farmacodinámico de SMN2 mRNA y no surgieran problemas de seguridad, el promotor prevee proporcionar acceso a RO6885247 a pacientes con AME incluidos en este estudio:
    Sin ninguna interrupción de tratamiento para pacientes infantiles con AME tipo 1.
    Tras la finalización de este estudio y después de completarse los estudios no clínicos de toxicología necesarios para el apoyar el tratmiento crónico para pacientes entre 2-55 años.
    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 Decision2015-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-15
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