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    Summary
    EudraCT Number:2020-003733-38
    Sponsor's Protocol Code Number:ORP-TMZ-I-b
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-01
    Trial 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 number2020-003733-38
    A.3Full title of the trial
    TEMOkids study (ORP-TMZ-I- b): A Population pharmacokinetic, acceptability and safety study for KIMOZO, a paediatric oral suspension of temozolomide
    Estudio TEMOkids: Un estudio farmacocinético para evaluar la aceptabilidad y la seguridad en la población de Kimozo, una suspensión oral pediátrica de temozolomida
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TEMOkids study: Study of the fate in the body, acceptability and safety study of KIMOZO, a drinkable form of temozolomide adapted to children
    Estudio TEMOkids: estudio del destino en el cuerpo, aceptabilidad y seguridad del uso de KIMOZO, forma potable de temozolomida adecuada para niños
    A.3.2Name or abbreviated title of the trial where available
    TEMOkids study
    Estudio TEMOkids
    A.4.1Sponsor's protocol code numberORP-TMZ-I-b
    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 SponsorORPHELIA Pharma
    B.1.3.4CountryFrance
    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 supportORPHELIA Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationORPHELIA Pharma
    B.5.2Functional name of contact pointContact
    B.5.3 Address:
    B.5.3.1Street Address85 boulevard Saint Michel
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75005
    B.5.3.4CountryFrance
    B.5.4Telephone number33142770818
    B.5.6E-mailcontact@orphelia-pharma.eu
    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 numberEU/3/19/2188
    D.3 Description of the IMP
    D.3.1Product nameKIMOZO
    D.3.2Product code ORP-005
    D.3.4Pharmaceutical form Oral suspension
    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 INNTEMOZOLOMIDE
    D.3.9.1CAS number 85622-93-1
    D.3.9.3Other descriptive nameTEMOZOLOMIDE
    D.3.9.4EV Substance CodeSUB10889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    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
    Different pediatric cancers such as malignant glioma and also relapsed or refractory neuroblastoma, rhabdomyosarcoma, medulloblastoma, and Ewing sarcoma, for which treatment with the cytotoxic temozolomide is recommended as per treatment guidelines.
    Diversos cánceres pediátricos como glioma maligno, neuroblastoma recidivante o refractario, rabdomiosarcoma, meduloblastoma y sarcoma de Ewing, para los cuales se recomienda el tratamiento con el fármaco citotóxico temozolomida en la estrategia de su manejo terapéutico.
    E.1.1.1Medical condition in easily understood language
    Different pediatric cancers for which treatment with the anticancer temozolomide is recommended as per treatment guidelines
    Diversos cánceres pediátricos para los cuales se recomienda el tratamiento con el fármaco contra el cáncer temozolomida en la estrategia de manejo terapéutico.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018337
    E.1.2Term Glioblastoma multiforme
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029260
    E.1.2Term Neuroblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10039022
    E.1.2Term Rhabdomyosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027107
    E.1.2Term Medulloblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate pharmacokinetic parameters of the oral suspension of temozolomide in the paediatric population aged 1 year and over
    Evaluar la farmacocinética de la suspensión oral de temozolomida en una población pediátrica de 1 año o más.
    E.2.2Secondary objectives of the trial
    Evaluate the safety of the oral suspension of temozolomide,
    Evaluate the acceptability of the oral suspension of temozolomide.
    Describe the activity of the oral suspension of temozolomide over the course of a 6-month-treatment period (complete or partial response, disease progression, stable disease) according to the standard follow up exams and tests recommended for each indication
    Evaluar la seguridad del uso de la suspensión oral de temozolomida.
    Evaluar la aceptabilidad de la suspensión oral de temozolomida.
    Describir la actividad de la suspensión oral de temozolomida durante un período de tratamiento de 6 meses (respuesta completa o parcial, progresión de la enfermedad, enfermedad estable) de acuerdo con los controles y exámenes estándar recomendados para cada indicación.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Paediatric patients already receiving commercially available temozolomide-based treatment or naïve paediatric patients requiring temozolomide-based treatment as per investigator’s decision (all indications with 5-day treatment per 21- or 28-day cycle). Indications include those described in the Temodal SmPC (i.e. malignant glioma such as glioblastoma and anaplastic astrocytoma). For patients having no therapeutic alternatives, the IMP may be used in off-label indications in accordance with current treatment protocols recommended by European and International Medical Associations (e.g. SIOPEN, EPSSG, COG, European ITCC, SIOP,…). Such indications include but are not limited to primarily neuroblastoma, medulloblastoma and also rhabdomyosarcoma, or Ewing sarcoma
    • Male and female patients aged 1 to less than 18 years
    • Patients who have signed the informed consent or for which one, both parents or legal guardian (depending on local legislation) have signed the informed consent.
    • Patients having records of coverage by a health insurance
    • Life expectancy ≥ 3 months
    • Adequate haematological function:
    o haemoglobin ≥ 80 g/L (transfusion support authorized)
    o neutrophil count ≥ 1.0 x 10e9 cells/L
    o platelet count ≥ 100 x 10e9 cells/L (without transfusion support)
    o in case of bone marrow involvement: neutrophils ≥ 0.5 x 10e9 cells/L and platelets ≥75 x 10e9 cells/L
    • Adequate renal function:
    o Creatine clearance ≥ 60 mL/min.1.73m² according to the Schwartz formula [1] or its modified form [2]
    • Adequate hepatic function:
    o bilirubin ≤1.5 x ULN
    o AST and ALT ≤ 2.5 x ULN (AST, ALT 5xULN in case of liver metastases)
    • Lansky Score ≥ 70%
    • Los pacientes pediátricos que ya están recibiendo tratamiento basado en la temozolomida disponibles comercialmente o pacientes pediátricos no tratados previamente que requieren un tratamiento a base de temozolomida según la decisión del investigador (todas las indicaciones con tratamiento de 5 días por ciclo de 21 o 28 días). Las indicaciones incluyen las descritas en el RCP de Temodal (es decir, glioma maligno como glioblastoma y astrocitoma anaplásico). Para pacientes que no tienen alternativas terapéuticas, el medicamento en investigación puede usarse en indicaciones no aprobadas de acuerdo con los protocolos de tratamiento actuales recomendados por las asociaciones médicas europeas e internacionales (por ejemplo, SIOPEN, EPSSG, COG, ITCC europeo, SIOP,…). Dichas indicaciones incluyen, entre otras, principalmente neuroblastoma, meduloblastoma y también rabdomiosarcoma o sarcoma de Ewing.
    • Los pacientes masculinos y femeninos de 1 año a menos de 18 años de edad.
    • Los pacientes que hayan firmado el consentimiento informado o para los que uno o ambos padres o tutor (dependiendo de la legislación local) hayan firmado el consentimiento informado.
    • Los pacientes que tengan registros de cobertura de un seguro médico
    • Expectativa de vida ≥ 3 meses
    • Función hematológica adecuada:
    o hemoglobina ≥ 80 g/l (con autorización para realizar transfusiones)
    o recuento de neutrófilos ≥ 1 x 109 células/litro
    o recuento de plaquetas ≥ 100 x 109 células/litro (sin transfusión)
    o en caso de afectación de la médula espinal: neutrófilos ≥ 0,5 x 109 células/litro y plaquetas ≥75 x 109 células/litro
    • Función renal adecuada:
    o Depuración de creatinina 60 ml/min. 1,73m² de acuerdo con la fórmula de Schwartz [1] o su forma modificada [2]
    • Función hepática adecuada:
    o bilirrubina ≤1,5 x ULN
    o AST y ALT ≤ 2,5 x ULN (AST, ALT 5 x ULN en caso de metástasis hepática)
    • Puntuación ≥ 70 % en la escala Lansky
    E.4Principal exclusion criteria
    • Patients who are co-administrated in the two weeks prior to receiving, and on day one of Kimozo administration at day one with sodium valproate as it decreases the clearance of temozolomide
    • Patients with (naso)gastric tube administration of temozolomide during first cycle of treatment
    • Patients already enrolled in studies investigating temozolomide or other investigational new drugs
    • A post-menarche female with a positive blood/urine pregnancy test at inclusion
    • Known contraindication or hypersensitivity to temozolomide or any chemically close substance
    • Los pacientes tratados con valproato de sodio en las dos semanas previas a recibir Kimozo o pacientes a los que se coadministra el día uno de la administración de Kimozo con valproato de sodio, ya que disminuye el aclaramiento de temozolomida.
    • Los pacientes con administración de temozolomida por sonda (naso)gástrica durante el primer ciclo de tratamiento.
    • Los pacientes que ya estén inscritos en estudios que investigan la temozolomida.
    • Una mujer en edad posmenarquia con una prueba de embarazo positiva en sangre u orina en el momento de la inclusión
    • Contraindicación conocida o hipersensibilidad a la temozolomida o cualquier sustancia con una composición química similar.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    Investigated PK parameters will be TMZ apparent clearance (CL/F), distribution volume (V/F) and absorption rate constant (Ka). These PK parameters will be used to derive key estimates of exposure such as TMZ area under the curve between 2 intakes (AUC0-t) and, if feasible, maximum concentration (Cmax) for each included subject and elimination half-life (t1/2), and the total AUC0-∞.
    Population PK parameters will be estimated by a population analysis performed with NONMEM (7.4). Individual Bayesian estimates of the PK parameters will be used to calculate individual AUC24, Cmax, and t1/2.
    Criterios primarios de valoración:
    Los parámetros farmacocinéticos investigados serán la depuración aparente de la temozolomida (CL/F), el volumen de distribución (V/F) y la constante de velocidad de absorción (Ka). Estos parámetros farmacocinéticos se utilizarán para obtener estimaciones fundamentales de exposición como el área de temozolomida por debajo de la curva entre dos ingestas (AUC0-t) y, en caso de ser posible, la concentración máxima (Cmax) para cada sujeto incluido y la semivida de eliminación (t1/2)
    Los parámetros farmacocinéticos de la población se calcularán mediante un análisis de la población realizado con NONMEM (7.4). Se usarán estimaciones individuales obtenidas por inferencia bayesiana de los parámetros farmacocinéticos para calcular los parámetros AUC24, Cmax y t1/2 individuales.
    E.5.1.1Timepoint(s) of evaluation of this end point
    A total of 6 blood samples of 1 ml will be drawn per patient in a single daytime hospitalisation. Blood samples will be collected in prechilled K2-EDTA tubes prior to Kimozo administration and at 0.10-0.20 (6-12 min), 0.33-0.66 (20-40 min), 0.75-1.5 (45-90 min), 2.0-3.0 and 6.0-8.0 hours post-dose. The administered dose and exact time for each sample will be recorded. Should a patient be naïve to any prior treatment with TMZ, the pre-treatment sample is not necessary.
    Se extraerán un total de 6 muestras de sangre de 1 ml por paciente en una sola hospitalización de día. Las muestras de sangre se extraerán en tubos K2-EDTA preenfriados antes de la administración de Kimozo y a 0.10-0.20 (6-12 min), 0.33-0.66 (20-40 min), 0.75-1.5 (45-90 min), 2.0-3.0 y 6,0 a 8,0 horas después de la dosis. Se registrará la dosis administrada y el tiempo exacto para cada muestra. Si un paciente no ha recibido ningún tratamiento previo con temolozomida la muestra de pretratamiento no es necesaria.
    E.5.2Secondary end point(s)
    Secondary endpoints:
    • Acceptability
    The acceptability of the oral suspension of temozolomide will be scored with a standardized assessment tool: CAST - ClinSearch Acceptability Score Test. This tool measures 9 observational drivers of medicine acceptability.
    • Safety
    All Safety events will be collected throughout the study, including buccal tolerance
    • Activity
    The clinical activity of the oral suspension of temozolomide during the compassionate use period will be described according to the standard follow-up exams and tests (i.e. complete or partial response, disease progression, stable disease)
    Criterios secundarios de valoración:
    • Aceptabilidad
    La aceptabilidad de la suspensión oral de temozolomida se clasificará con una herramienta de evaluación estandarizada: CAST - ClinSearch Acceptability Score Test®. Esta herramienta mide nueve indicadores observacionales de la aceptabilidad del medicamento.
    •Seguridad
    Todos los eventos adversos, incluida la tolerancia oral, se recopilarán durante todo el estudio.
    • Actividad
    La actividad clínica de la suspensión oral de temozolomida durante la fase de tratamiento compasivo se describirá utilizando los exámenes y pruebas utilizados por el centro de investigación en la práctica actual (respuesta completa o parcial, progresión de la enfermedad, enfermedad estable)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints:
    • Acceptability
    A paper diary will be filled-in to assess palatability/acceptability of the oral suspension of temozolomide.
    • Safety
    Safety events recorded by the caregiver in the patient diary will be medically controlled on a monthly basis by the principal investigator.
    Safety follow-up during the 1st cycle : 21 or 28 days, including buccal tolerance at day 5 and until day 21 or 28
    Safety follow-up during the compassionate-use period for 5 potential additional treatment cycles.
    • Activity
    The clinical activity during the compassionate use period will be assessed when planned for the standard follow-up exams and tests
    Criterios secundarios de valoración:
    • Aceptabilidad
    Se completará un diario en papel para evaluar la palatabilidad/aceptabilidad de la suspensión oral de temozolomida
    • Seguridad
    Los eventos adversos, registrados en el diario del paciente por la persona responsable del niño, serán revisados ​​médicamente por el investigador mensualmente
    Seguimiento de la tolerancia durante el 1er ciclo: durante 21 o 28 días, incluida la tolerancia oral el D5 y hasta 21 o 28 días.
    Seguimiento de la tolerancia durante la fase compasiva durante 5 posibles ciclos de tratamiento adicionales
    • Actividad
    La actividad clínica durante la fase compasiva se evaluará durante los exámenes y pruebas en la práctica actual
    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 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) 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
    population pharmacokinetic study
    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 No
    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 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.8.2.4Number 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 EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 40
    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: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    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
    paediatric patients from the age of 1 year to be included, thus incapable of giving consent personnally
    des patients pédiatriques à partir de 1 ans, incapables de donner personnellement leur consentement, seront inclus
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Already included in the protocol, a follow up compassionate period of up to 5 additional treatment cycles after the main study period made of 1 cycle of treatment with the oral suspension of the cytotoxic drug temozolomide
    Inclus dans le protocole, une période compassionnelle de suivi comprenant jusqu'à 5 cycles de traitement additionnel après la période principale de l'étude faite d'un seul cycle de traitement avec la suspension buvable du médicament cytotoxique témozolomide
    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 Decision2021-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-29
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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