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    Summary
    EudraCT Number:2015-001985-25
    Sponsor's Protocol Code Number:250-201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-01-13
    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 number2015-001985-25
    A.3Full title of the trial
    A Phase 1/2 Open-Label Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intracerebroventricular BMN 250 in Patients with Mucopolysaccharidosis Type IIIB (MPS IIIB, Sanfilippo Syndrome Type B)
    Estudio abierto con aumento de la dosis en fase 1/2 para evaluar la seguridad, tolerabilidad, farmacocinética y eficacia del BMN 250 intracerebroventricular en pacientes con mucopolisacaridosis tipo IIIB (MPS IIIB, Síndrome de Sanfilippo tipo B)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1/2 Study to Evaluate the Safety and Efficacy of BMN 250 in Patients with MPS IIIB
    Estudio fase 1/2 para evaluar la seguridad y eficacia de BMN 250 en pacientes con MPS IIIB.
    A.4.1Sponsor's protocol code number250-201
    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 SponsorBioMarin Pharmaceutical 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 supportBioMarin Pharmaceutical Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioMarin Pharmaceutical Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address105 Digital Drive
    B.5.3.2Town/ cityNovato
    B.5.3.3Post code94949
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@bmrn.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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/213/14
    D.3 Description of the IMP
    D.3.1Product nameN/A
    D.3.2Product code BMN 250
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraventricular use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeBMN 250
    D.3.9.3Other descriptive nameRHNAGLU-IGF2
    D.3.9.4EV Substance CodeSUB177868
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Mucopolysaccharidosis Type IIIB (Sanfilippo Syndrome Type B, MPS IIIB)
    Mucopolisacaridosis tipo IIIB (MPS IIIB, Síndrome de Sanfilippo tipo B)
    E.1.1.1Medical condition in easily understood language
    NAGLU deficiency
    Deficiencia NAGLU
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10056918
    E.1.2Term Sanfilippo's syndrome
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10056890
    E.1.2Term Mucopolysaccharidosis III
    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 BMN 250 administered to subjects with MPS IIIB by an implanted intracerebroventricular (ICV) reservoir and catheter.

    To evaluate the impact of BMN 250 on cognitive function in patients with MPS IIIB as assessed by development quotient (DQ).
    Evaluar la seguridad y tolerabilidad del BMN 250 administrado a pacientes con MPS IIIB mediante un depósito implantado y un catéter ICV.

    Evaluar el impacto de BMN 250 en la función cognitiva de pacientes con MPS IIIB, evaluado por el coeficiente de desarrollo (DQ).
    E.2.2Secondary objectives of the trial
    To characterize single- and repeated-dose pharmacokinetics (PK) of BMN 250 in cerebrospinal fluid (CSF) and plasma.

    To characterize immunogenicity of BMN 250 in CSF and serum.

    To evaluate the impact of BMN 250 treatment on CSF, serum, and urine GAGs.

    To evaluate the impact of BMN 250 treatment on brain structure assessed by MRI.
    Caracterizar la farmacocinética (FC) de dosis únicas y repetidas de BMN 250 en el líquido cefalorraquídeo (LCR) y el plasma.

    Caracterizar la inmunogenicidad del BMN 250 en el LCR y el suero.

    Evaluar el impacto del tratamiento con BMN 250 en los GAG en el LCR, el suero y la orina.

    Evaluar el impacto del tratamiento con BMN 250 en la estructura cerebral, evaluado por resonancia magnética (RM).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part 1: Dose Escalation Period:

    Has deficient NAGLU enzyme activity at screening.

    Is between 1 and 10 years of age.

    Has presented with signs/symptoms consistent with MPS IIIB; for individuals who have not presented with signs/symptoms of the disease (e.g., siblings of known patients), the determination of eligibility will be at the discretion of the BioMarin medical monitor in conjunction with the site investigator.

    Written informed consent from parent or legal guardian and assent from subject, if required.

    Has the ability to comply with protocol requirements, in the opinion of the investigator.

    Part 2: Stable Dose Period:

    Participated in and met protocol requirements for transitioning from Study 250-901 or participated in Part 1 of Study 250-201

    Written informed consent from parent or legal guardian and assent from subject, if required
    Parte 1: Período de aumento de la dosis:

    Tener actividad deficiente de la enzima NAGLU en el momento de la selección.

    Tener entre 1 y 10 años de edad

    Haber presentado signos/síntomas compatibles con MPS IIIB; en el caso de los pacientes que no hayan presentado signos/síntomas de enfermedad (p. ej., hermanos de pacientes conocidos), la determinación de la idoneidad quedará a criterio del monitor médico de BioMarin en conjunción con el investigador del centro.

    Consentimiento informado por escrito de los padres o del tutor legal y asentimiento del paciente, si se requiere.

    Según la opinión del investigador, es capaz de cumplir los requisitos del protocolo

    Parte 2: Período de dosis estable:

    Haber participado y cumplido los requisitos del protocolo para pasar del estudio 250-901 o haber participado en la parte 1 del estudio 250-201.

    Consentimiento informado por escrito de los padres o del tutor legal y asentimiento del paciente, si se requiere.
    E.4Principal exclusion criteria
    Part 1: Dose Escalation Phase:

    Has received stem cell, gene therapy, or enzyme replacement therapy for MPS IIIB.

    Has contraindications for neurosurgery (e.g., congenital heart disease, severe respiratory impairment, or clotting abnormalities).

    Has contraindications for MRI scans (e.g., cardiac pacemaker, metal fragment or chip in the eye, or aneurysm clip in the brain).

    Has a history of poorly controlled seizure disorder.

    Is prone to complications from intraventricular drug administration, including patients with hydrocephalus or ventricular shunts.

    Has received any investigational medication within 30 days prior to the Baseline visit or is scheduled to receive any investigational drug during the course of the study.

    Has a medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise the subject's ability to comply with protocol requirements, the subject's well-being or safety, or the interpretability of the subject's clinical data.

    Is pregnant at any time during the study

    Part 2: Stable Dose Period:
    Has received stem cell, gene therapy or ERT for MPS IIIB

    Has contraindications for neurosurgery (e.g., congenital heart disease, severe respiratory impairment, or clotting abnormalities)

    Has contraindications for MRI scans (e.g., cardiac pacemaker, metal fragment or chip in the eye, or aneurysm clip in the brain)

    Is prone to complications from intraventricular drug administration, including patients with hydrocephalus or ventricular shunts

    Has received any investigational medication within 30 days prior to the Baseline visit or is scheduled to receive any investigational drug during the course of the study

    Has a medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise the subject´s ability to comply with protocol requirements, the subject´s well-being or safety, or the interpretability of the subject´s clinical data.

    Is pregnant at any time during the study
    Parte 1: Período de aumento de la dosis
    Haber recibido células madre, terapia génica o tratamiento enzimático sustitutivo (TES) para la MPS IIIB.

    Tener contraindicaciones para la neurocirugía (p. ej. cardiopatía congénita, trastorno respiratorio grave o alteraciones de la coagulación).

    Tener contraindicaciones para las exploraciones por RM (p. ej., marcapasos cardíaco, fragmento metálico o chip en el ojo o un clip para aneurisma en el cerebro).

    Tener antecedentes de trastorno convulsivo mal controlado.

    Ser propenso a tener complicaciones por la administración intraventricular de medicamentos, incluidos pacientes con hidrocefalia o derivaciones ventriculares.

    Haber recibido algún medicamento en fase de investigación en los 30 días anteriores a la visita inicial o tener programada la administración de algún medicamento en fase de investigación durante el transcurso del estudio.

    Tener un problema médico o circunstancias atenuantes que, en opinión del investigador, podrían afectar a la capacidad del paciente para cumplir los requisitos del protocolo, el bienestar o la seguridad del paciente o la interpretación de los datos clínicos del paciente.

    Estar embarazada en cualquier momento durante el estudio.

    Parte 2: Período de dosis estable:
    Haber recibido células madre, terapia génica o tratamiento enzimático sustitutivo (TES) para la MPS IIIB.

    Tener contraindicaciones para la neurocirugía (p. ej. cardiopatía congénita, trastorno respiratorio grave o alteraciones de la coagulación).

    Tener contraindicaciones para las exploraciones por RM (p. ej., marcapasos cardíaco, fragmento metálico o chip en el ojo o un clip para aneurisma en el cerebro).

    Ser propenso a tener complicaciones por la administración intraventricular de medicamentos, incluidos pacientes con hidrocefalia o derivaciones ventriculares.

    Haber recibido algún medicamento en fase de investigación en los 30 días anteriores a la visita inicial o tener programada la administración de algún medicamento en fase de investigación durante el transcurso del estudio.

    Tener un problema médico o circunstancias atenuantes que, en opinión del investigador,podrían afectar a la capacidad del paciente para cumplir los requisitos del protocolo, el bienestar o la seguridad del paciente o la interpretación de los datos clínicos del paciente.

    Estar embarazada en cualquier momento durante el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the safety and tolerability of BMN 250 administered to subjects with MPS IIIB by an implanted intracerebroventricular (ICV) reservoir and catheter.

    To evaluate the impact of BMN 250 on cognitive function in patients with MPS IIIB as assessed by developmental quotient (DQ).
    Evaluar la seguridad y tolerabilidad del BMN 250 administrado a pacientes con MPS IIIB mediante un depósito implantado y un catéter ICV.

    Evaluar el impacto de BMN 250 en la función cognitiva de pacientes con MPS IIIB, evaluado por el coeficiente de desarrollo (DQ).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety and tolerability reviews include: continuous monitoring of AEs and concomitant medications; clinical lab assessments at Screening, prior to/day after first dose at each dose level and Q4W until next dose escalation in Part1, and Screening, prior to/day after first dose and Q4W thereafter in Part2;CSF for cell count, protein, glucose collected prior to weekly infusions; pre/post-dose blood samples for serial PK analysis monitored for glucose level; complete physical exam at Screening, Baseline and dose escalation visits in Part1 and Baseline and Weeks 24 and 48 in Part2; brief physical exams at weekly dosing visits when complete exams not performed; ECG and EEG at Screening and end of study.

    Neurocognitive tests at Baseline in Part1, and Baseline, Weeks 12, 24, 36, 48 in Part2.
    Las evaluaciones de seguridad y tolerabilidad incluyen: monitorización continua de AA y medicación concomitante; evaluaciones de lab clínico en S, antes de/ día tras primera dosis en cada nivel de dosis y C4S hasta próx aumento de dosis en P1, y selección, antes de/ día tras primera dosis y C4S en P2; LCR para conteo de células, proteínas, glucosa recolectada antes de infusiones semanales; muestras de sangre pre/ post dosis para análisis PK serie monitorizado para nivel de glucosa; examen físico completo en visitas de selección, basal y escalada de dosis en P1 y basal y en S24 y 48 en P2; exámenes físicos breves en visitas semanales de dosificación cuando no se han hecho completos; ECG y EEG en selección y final del estudio.
    Pruebas neurocognitivas en basal P1 y B, S 12, 24, 36, 48 en P2.
    E.5.2Secondary end point(s)
    The secondary objectives of this study are:
    *to characterize single- and repeated-dose pharmacokinetics (PK) of BMN 250 in cerebrospinal fluid (CSF) and plasma
    *to characterize immunogenicity of BMN 250 in CSF and serum
    *to evaluate the impact of BMN 250 treatment on CSF, serum and urine GAGs
    *to evaluate the impact of BMN 250 treatment on brain structure assessed by magnetic resonance imaging (MRI)
    Los objetivos secundarios de este estudio son:
    -Caracterizar la farmacocinética (FC) de dosis únicas y repetidas de BMN 250 en el líquido cefalorraquídeo (LCR) y el plasma.
    - Caracterizar la inmunogenicidad del BMN 250 en el LCR y el suero.
    - Evaluar el impacto del tratamiento con BMN 250 en los GAG en el LCR, el suero y la orina.
    - Evaluar el impacto del tratamiento con BMN 250 en la estructura cerebral, evaluado por resonancia magnética (RM).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Sampling of CSF and blood (plasma) for serial PK and GAG analyses will be following the first dose and subsequent dose escalations in Part 1 and for the doses administered at Baseline, and Weeks 5, 12 and 36 in Part 2. CSF and blood (plasma) samples will also be used for trough PK performed Q4W in Part 2.

    CSF and serum will be drawn throughout the study to analyze immunogenicity.

    Urine will be collected for GAGs/creatinine analysis prior to initial dosing at each dose level and Q4W until the next dose escalation in Part 1, and Baseline and Q4W thereafter in Part 2.

    Brain structure will be evaluated by MRI during both Part 1 and Part 2 Baseline visits and at Weeks 24 and 48 in Part 2.
    Muestras de LCR y sangre (plasma) para análisis de PC serial y GAG seguirán la primera dosis y escaladas de dosis posteriores en parte 1 y para dosis administradas en Basal, y semanas 5, 12 y 36 en la Parte 2. LCR y smuestras de sangre (plasma) se utilizarán también para PKC realizada C4S en Parte 2.

    LCR y suero se extraerán durante todo el estudio para analizar la inmunogenicidad.

    La orina se recogerá para su análisis GAG / creatinina antes de la primera dosis en cada nivel de dosis y C4S hasta el próximo aumento de la dosis en la parte 1, y la línea de base y C4S a partir de entonces en la parte 2.

    La estructura del cerebro será evaluado por RM tanto en Parte 1 y Parte 2 durante las visitas Basales, y en semanas 24 y 48 en la parte 2.
    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 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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 No
    E.8.1.2Open Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Baseline Control
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Baseline Control
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Brazil
    Colombia
    Germany
    Spain
    Taiwan
    Turkey
    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
    LVLS
    UVUP
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 33
    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: 5
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 28
    F.1.1.6Adolescents (12-17 years) No
    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 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
    The subjects included in this trial are between 1 to 10 years of age. Therefore before any study-related procedures are performed, parents or legal guardians of the subjects must provide informed consent, and if required, subjects must assent.
    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 15
    F.4.2.2In the whole clinical trial 33
    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)
    Expected normal treatment for the condition
    Tratamiento normal esperado para la condición
    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 Decision2016-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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