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    Summary
    EudraCT Number:2016-000657-12
    Sponsor's Protocol Code Number:ACT14820
    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:2016-10-24
    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 number2016-000657-12
    A.3Full title of the trial
    Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia, seguridad, farmacocinética y farmacodinamia de GZ/SAR402671 en pacientes con Enfermedad de Parkinson en estadio inicial, portadores de la mutación GBA u otra variante pre-especificada
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation
    Estudio global para evaluar la eficacia, seguridad, farmacocinética y farmacodinamia de GZ/SAR402671 en pacientes con Enfermedad de Parkinson, portadores de la mutación del gen GBA (gen de la glucocerebrosidasa)
    A.3.2Name or abbreviated title of the trial where available
    MOVES-PD
    A.4.1Sponsor's protocol code numberACT14820
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1180-6918
    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 SponsorGenzyme Corporation
    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 supportGenzyme Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 9400
    B.5.6E-mailES-unidadestudiosclinicos@sanofi.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 SAR402671, GZ402671 or GZ/SAR402671
    D.3.4Pharmaceutical form 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 INNNA
    D.3.9.1CAS number 1401090-53-6
    D.3.9.2Current sponsor codeGZ/SAR402671
    D.3.9.3Other descriptive nameGenz-682452-AU
    D.3.9.4EV Substance CodeSUB166602
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 SAR402671, GZ402671 or GZ/SAR402671
    D.3.4Pharmaceutical form 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 INNNA
    D.3.9.1CAS number 1401090-53-6
    D.3.9.2Current sponsor codeGZ/SAR402671
    D.3.9.3Other descriptive nameGenz-682452-AU
    D.3.9.4EV Substance CodeSUB166602
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 placeboCapsule
    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
    Parkinson's disease (PD) carrying a GBA mutation
    Enfermedad de Parkinson (EP) portadores de la mutación GBA
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease
    Enfermedad de Parkinson
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -Part 1: To determine the safety and tolerability of GZ/SAR402671 administered orally, as compared to placebo in patients with early-stage Parkinson's disease (PD) carrying a GBA mutation or other pre-specified variants.
    -Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as compared to placebo in patients with early-stage Parkinson's disease carrying a GBA mutation or other prespecified variants.
    Parte 1: Determinar la seguridad y la tolerabilidad de GZ/SAR402671 en comparación con placebo, administrado por vía oral durante 4 semanas en pacientes con Enfermedad de Parkinson (EP) en fase temprana portadores de una mutación en el gen de la glucocerebrosidasa (GBA) u otras variantes de la secuencia pre-especificadas.
    Parte 2: Determinar la eficacia de GZ/SAR402671 en pacientes con EP en estadio inicial portadores de una mutación en GBA or other pre-specified variants, al administrarlo a diario por vía oral.
    E.2.2Secondary objectives of the trial
    Part 1:
    -To assess the pharmacokinetic (PK) profile of oral dosing of GZ/SAR4027671 in plasma when administered in early-stage Parkinson's disease patients carrying a GBA mutation.
    -To assess the exposure of GZ/SAR402671 in cerebrospinal fluid (CSF) when administered in earlystage Parkinson's disease patients carrying a GBA mutation.
    Part 2:
    -To demonstrate overall safety and tolerability of GZ/SAR4027671 administered orally in early-stage Parkinson's disease patients carrying a GBA mutation as compared to placebo.
    -To assess the pharmacodynamic response to daily oral dosing of GZ/SAR402671 in plasma and CSF as measured by glucosylceramide (GL-1) when administered in early-stage Parkinson's disease patients carrying a GBA mutation.
    Parte 1:
    Evaluar el perfil farmacocinético (FC) en plasma de la administración oral en pacientes con EP en fase temprana portadores de una mutación en GBA.
    Evaluar la exposición del líquido cefalorraquídeo (LCR) a GZ/SAR402671 al administrarlo en pacientes con EP en estadio inicial portadores de una mutación en GBA.
    Parte 2:
    Demostrar la seguridad y la tolerabilidad generales de GZ/SAR402671 administrado por vía oral a pacientes con EP en estadio inicial portadores de una mutación en GBA, en comparación con placebo.
    Evaluar la respuesta farmacodinámica en el plasma y en el LCR ante la administración de dosis diarias por vía oral de GZ/SAR402671, medida a través de la GL-1 en pacientes con EP en estadio inicial portadores de una mutación en GBA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male and female adults with a diagnosis of PD and who are heterozygous carriers of a GBA mutation associated with PD.
    -Patients carrying known sequence variants associated with GBA-PD (such as E326K) must have rapid eye movement (REM) sleep behavior disorder (RBD) confirmed by historically documented polysomnography or by questionnaire.
    -Age ≥18 years to 70 years inclusive at the time of informed consent signing.
    -Has symptoms of PD ≥2 years.
    -Hoehn and Yahr (H and Y) stage of 2 or lower at baseline.
    -Stable medication regimen of PD drugs for at least 30 days (at least 60 days for rasagiline) prior to randomization.
    -The patient is willing to abstain from grapefruit containing products for 72 hours prior to administration of the first dose of GZ/SAR402671 and for duration of the entire treatment period (Periods 2 and 3).
    -Signed written consent.
    I 01. Sujetos de sexo masculino o femenino con diagnóstico de EP (con al menos dos de los signos siguientes: temblor de reposo, inestabilidad postural, acinesia/hipocinesia y rigidez muscular) y que sean portadores heterocigóticos de una mutación en GBA.
    I 02. En los pacientes portadores de variantes de secuencias conocidas asociadas a EP-GBA debe confirmarse el trastorno de conducta del sueño REM (TCR) mediante una polisomnografía documentada históricamente o un cuestionario de detección del TCR.
    I 03. Edad desde mayor o igual a 18 años hasta 70 años, inclusive, en el momento de la firma del consentimiento informado.
    I 04. Presentar síntomas de EP durante mayor o igual a 2 años.
    I 05. Estadio de la EP de Hoehn y Yahr (HyY) menor o igual a 2 al inicio.
    I 06. Si está en tratamiento con levodopa o con un agonista dopaminérgico, la medicación debe permanecer estable durante al menos 30 días (como mínimo 60 días para la rasagilina) antes de la aleatorización.
    I 07. Colaborador, capaz de ingerir medicación por vía oral y de llevar a cabo todos los aspectos del estudio solo, según el criterio del investigador.
    I 08. Paciente dispuesto a abstenerse de consumir pomelo, zumo de pomelo o productos a base de pomelo durante las 72 horas previas a la administración de la primera dosis de GZ/SAR402671 y durante todo el periodo de tratamiento (Parte 1 y Parte 2, Periodos 2 y 3).
    I 09. Capaz de proporcionar un consentimiento informado por
    escrito firmado.
    E.4Principal exclusion criteria
    -Parkinsonism due to drug(s) or toxin(s).
    -Patients carrying mutations in genes other than GBA that have been associated with an increased risk for PD, specifically LRKK2 (G2019S).
    -Patients with Gaucher disease (GD), defined by the presence of 2 mutated GBA alleles.
    -Montreal Cognitive Assessment score <20 at Screening Visit.
    -Patients with prior surgical history of deep brain stimulation (DBS).
    -Patients with baseline brain MRI without contrast showing a structural abnormality that is a possible cause of their PD signs or symptoms.
    -Hepatic insufficiency with liver function tests (LFT) >2 times upper limit of normal at Screening Visit.
    -The patient has prior known positive result on any of the following tests: hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV 1 and anti-HIV 2 Ab). Patients with a positive hepatitis B surface antibody (HBsAb) test with a history of prior hepatitis B immunization are eligible if other criteria are met (ie, negative tests for : HBsAg, hepatitis B core antibody [HBcAb],and hepatitis C [HCVAb].
    -Renal insufficiency as defined by creatine >1.5 times normal at Screening Visit.
    -The patient has received strong or moderate inducers or inhibitors of CYP3A4 within 30 days or 5 half-lives from screening, whichever is longer, prior to randomization.
    -The patient has, according to World Health Organization (WHO) Grading, a cortical cataract > onequarter the lens circumference (grade cortical catact-2 [COR-2]) or a posterior subcapsular cataract >2 mm (grade posterior subscapsular cataract [PSC-2]). Patient with nuclear cataracts will not be excluded.
    -The patient is currently receiving potentially cataractogenic medications, including chronic regimen (more frequently than every 2 weeks) of any dose or route of corticosteroids or any medication that can cause cataract, according to the prescribing information.
    -If female, pregnancy (defined as positive beta-human chorionic gonadotrophin [Beta-HCG] blood test) or lactating or breast-feeding.
    -Any medical disorders that, in the opinion of the Investigator, could interfere with study-related procedures. This includes condition(s) that preclude the safety performance of routine lumbar punctures, such as prohibitive spinal diseases, bleeding diasthesis, or clinically significant coagulopathy or thrombocytopenia.
    -Current participation in another investigational interventional study.
    - Parkinsonismo causado por fármacos o toxinas.
    - Pacientes portadores de la mutación LRRK2 G2019S.
    - Pacientes con enfermedad de Gaucher (EG), definida a través de síntomas y signos clínicos (es decir, hepatoesplenomegalia, citopenia, osteopatía) o deficiencia pronunciada de la actividad de la glucocerebrosidasa (GCasa) compatible con EG.
    - Puntuación en el MoCA menor a 20.
    - Pacientes con antecedentes quirúrgicos de estimulación cerebral profunda.
    - Pacientes con una RM basal sin contraste que muestre anomalías estructurales que puedan constituir una posible etiología para los signos y síntomas relacionados de la EP.
    - Cualquier trastorno médico o hallazgo clínicamente relevante en la exploración física, los antecedentes médicos o las pruebas analíticas que, en opinión del Investigador, pueda interferir en los procedimientos relacionados con el estudio (como por ejemplo, insuficiencia cardíaca, hipopotasemia, etc.). Esto incluye aquellas afecciones que impidan llevar a cabo la PL de manera segura, como enfermedad medular lumbar prohibitiva, diátesis hemorrágica, o coagulopatía o trombocitopenia clínicamente significativas.
    - Insuficiencia renal definida por la creatina 1,5 veces superior a los valores normales en la visita de selección.
    - Paciente que haya recibido inductores o inhibidores potentes o moderados del CYP3A4 durante los 30 días o las 5 semividas previas a la selección, lo que suponga más tiempo, antes de la aleatorización.
    - Paciente que presente, según la clasificación de la Organización Mundial de la Salud (OMS), una catarata cortical > un cuarto de la circunferencia del cristalino (catarata cortical de grado 2) o una catarata subcapsular posterior > 2 mm (catarata subcapsular posterior de grado 2). No se excluirá a los pacientes con cataratas nucleares.
    - Paciente que esté recibiendo medicación potencialmente cataratógena, incluidas las pautas crónicas (con una frecuencia mayor de cada 2 semanas) sea cual sea la dosis
    o la vía de administración de corticoesteroides o de cualquier medicamento que pueda provocar cataratas, según la Ficha Técnica.

    - Si es mujer, embarazo (definido como resultado positivo en la prueba de gonadotropina coriónica humana β [β-HCG] en sangre) o que esté en periodo de lactancia o amamantando.
    - Cualquier trastorno médicos que, en opinión del investigador, podría interferir con los procedimientos relacionados con el estudio. Esto incluye la condición (s) que impide el funcionamiento de la seguridad de las punciones lumbares de rutina, tales como las enfermedades de la columna vertebral, diátesis sangrante, o coagulopatía clínicamente significativo o trombocitopenia.
    - Pacientes que estén participando actualmente en otro estudio de intervención en fase de investigación.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in Movement Disorder Society Unified Parkinson’s Disease Rating Scale Part II and III score
    Cambio desde el inicio en Escala unificada para la evaluación de la Enfermedad de Parkinson de la Sociedad de Trastornos del Movimiento (MDS-UPDRS) PARTES II+III
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 52
    Desde la basal a la semana 52
    E.5.2Secondary end point(s)
    - Change from baseline in Parkinson's Disease Cognitive Rating Scale
    - Change from baseline in Movement Disorder Society Unified Parkinson’s Disease Rating Scale Part I, II, and III score
    - Change from baseline in Hoehn and Yahr score
    - Cambio respecto al inicio en la Escala de puntuación cognitiva de la Enfermedad de Parkinson
    - Cambio respecto al inicio en la Escala unificada para la evaluación de la Enfermedad de Parkinson de la Sociedad de Trastornos del Movimiento (MDSUPDRS) PARTES I+II+III.
    - Cambio respecto al inicio en la puntuación de Hoehn y Yahr.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to Week 52
    Desde la basal a la semana 52
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 EEA17
    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
    Austria
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Norway
    Portugal
    Singapore
    Spain
    Sweden
    Taiwan
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 218
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 58
    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 No
    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 95
    F.4.2.2In the whole clinical trial 276
    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)
    At the end of a 52-week main placebo-controlled treatment period, all patients will be evaluated for possibility to transition to receive active treatment for 104 weeks plus 6 week post-treatment observation.
    Al final del período de tratamiento principal controlado con placebo de 52 semanas, todos los pacientes serán evaluados para posibilidad de transición para recibir el tratamiento activo durante 104 semanas más observación post-tratamiento de 6 semanas.
    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 Decision2016-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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