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    Summary
    EudraCT Number:2021-005331-23
    Sponsor's Protocol Code Number:SCOUT-015
    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:2022-04-18
    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 number2021-005331-23
    A.3Full title of the trial
    A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients with Prader-Willi Syndrome
    Estudio en Fase II/III aleatorizado, doble ciego, controlado con placebo de RAD011 (Cannabidiol Solución Oral) para el tratamiento de pacientes con el síndrome de Prader-Willi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients with Prader-Willi Syndrome
    Estudio de RAD011 (Cannabidiol Solución Oral) para el tratamiento de pacientes con el síndrome de Prader-Willi
    A.4.1Sponsor's protocol code numberSCOUT-015
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05098509
    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 SponsorRadius Pharmaceuticals, 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 supportRadius Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadius Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address22 Boston Wharf Rd, 7th Floor
    B.5.3.2Town/ cityBoston
    B.5.3.3Post codeBoston, MA 0221
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617551-4700
    B.5.5Fax number+1617551-4701
    B.5.6E-mailSCOUT015@radiuspharm.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRAD011
    D.3.2Product code RAD011
    D.3.4Pharmaceutical form Oral solution in bottle
    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 INNCannabidiol
    D.3.9.1CAS number 13956-29-1
    D.3.9.4EV Substance CodeSUB26600
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 in bottle
    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
    Hyperphagia related behavior associated with Prader-Willi Syndrome
    Comportamiento relacionado con la hiperfagia asociada al síndrome de Prader-Willi
    E.1.1.1Medical condition in easily understood language
    Uncontrollable appetite behavior associated with Prader-Willi Syndrome
    Comportamiento de apetito no controlado asociado al síndrome de Prader-Willi
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10020710
    E.1.2Term Hyperphagia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 2 Part:
    The primary objective of the Phase 2 part of this study is to assess the safety and tolerability of multiple doses levels of RAD011 in order to select 1 or 2 dose level(s) to further evaluate in the Phase 3 part of the study.
    Phase 3 Part:
    The primary objective of the Phase 3 part of this study is to assess the effect of RAD011 on hyperphagia-related behavior in patients with PWS.
    Fase II:
    El objetivo principal de la Fase II de este estudio es evaluar la seguridad y la tolerabilidad de múltiples niveles de dosis de RAD011 con el fin de seleccionar 1 o 2 niveles de dosis para evaluar en mayor profundidad en la Fase III del estudio.
    Fase III:
    El objetivo principal de la Fase III de este estudio es evaluar el efecto de RAD011 en la conducta relacionada con la hiperfagia en pacientes con el síndrome de Prader Willi (SPW).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the following:
    - Effect of RAD011 on irritability
    - Effect of RAD011 on Clinician Global Impression of Change (CGI-C) in Hyperphagia
    - Effect of RAD011 on Clinician Global Impression of Severity(CGI-S) of Hyperphagia
    - Safety and tolerability of RAD011.

    Other objectives of this study are to assess the following:
    - Effect of RAD011 on Caregiver Global Impression of Change (CaGI-C) in Hyperphagia
    - Effect of RAD011 on Caregiver Global Impression of Severity (CaGI-S) of Hyperphagia
    - Effect of RAD011 on Caregiver Global Impression of Change (CaGI-C) in Irritability
    - Effect of RAD011 on overall behavior
    - Effect of RAD011 on sleep
    - Effect of RAD011 on body mass index (BMI) and weight
    - Effect of RAD011 on skin-picking behavior
    - Effect of RAD011 on total muscle/fat composition (performed at selected US sites).
    Los objetivos secundarios del estudio son evaluar lo siguiente:
    - Efecto de RAD011 en la irritabilidad
    - Efecto de RAD011 en la Escala de Impresión Clínica Global del Cambio (CGI-C) en la hiperfagia
    - Efecto de RAD011 en la Escala de Impresión Clínica Global de la Gravedad (CGI-S) de la hiperfagia
    - Seguridad y tolerabilidad de RAD011
    Los otros objetivos de este estudio son evaluar lo siguiente:
    - Efecto de RAD011 en la Escala de Impresión Global del Cuidador del Cambio (CaGI-C) en la hiperfagia
    - Efecto de RAD011 en la Escala de Impresión Global del Cuidador de la Gravedad (CaGI-S) de la hiperfagia
    - Efecto de RAD011 en la Escala de Impresión Global del Cuidador del Cambio (CaGI-C) en la irritabilidad
    - Efecto de RAD011 en el comportamiento general
    - Efecto de RAD011 en el sueño
    - Efecto de RAD011 en el Índice de Masa Corporal y el peso
    - Efecto de RAD011 en el trastorno de excoriación
    - Efecto de RAD011 en la composición total de músculo/grasa (en centros de EE. UU.)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Presence of a parent/legal guardian that is able to consent for their participation. Parent/caregiver/legal guardian can complete the required assessments throughout the study. Patient consent/assent will be obtained if the patient is 8 years of age or older and has the mental capacity to understand and sign a written consent/assent form and/or give verbal assent
    2. Males and females between:
    a. Phase 2: 12 and 65 years of age (inclusive) at time of consent/assent
    b. Phase 3: 8 and 65 years of age (inclusive) at time of consent/assent
    3. Documentation of genetically confirmed PWS diagnosis
    4. If a caregiver helps in completing the HQ-CT or other questionnaires, the same caregiver is available to complete the questionnaire throughout the duration of the study
    5. If female, is either not of childbearing potential (defined as premenarchal or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or practicing one of the following medically acceptable methods of birth control up to 4 weeks after the last dose of RAD011 or placebo:
    a. Double barrier method (i.e., condom plus occlusive cap (diaphragm or cervical/vault caps), condom or occlusive cap plus spermicide
    b. Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives at a stable dose for a minimum of 1 full cycle (based on the patient’s usual menstrual cycle period) before IP administration
    c. Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
    d. If not using hormonal contraceptives or IUD or IUS, then all male partners throughout the study must have been vasectomized and have received medical assessment of the surgical success
    6. If male, is vasectomized and has received medical assessment of the surgical success or agrees to use an approved method of contraception (double barrier method as described in Inclusion Criterion 5, female partner’s use of an IUD or IUS [in place at least 12 weeks prior to dosing], oral contraceptives or female partner who is surgically sterile or 2 years postmenopausal) and agrees to use this method for 4 weeks after last administration of RAD011 or placebo
    7. If receiving growth hormone (GH), psychotropic therapy, metabolic treatments that could affect appetite (including metformin), and other treatment including thyroid hormone, must be on the same medication and stable dose for at least 90 days prior to consent/assent
    8. Any non-medical interventions (eg, counseling, behavior modification) should be stable for at least 90 days prior to consent/assent
    9. HQ-CT eligibility automatically calculated in the electronic data capture (EDC) system:
    a. Visit 2
    i. Patients with a mean HQ-CT score ≥13 (from Visit 1 and Visit 2) will be eligible to continue in the Tolerability Period
    b. Visit 5
    i. Patients with a mean HQ-CT score ≥13 (from Visit 3, Visit 4 and Visit 5) will be eligible for randomization, and
    ii. Patients with a decrease in HQ-CT score (from Tolerability Period to the Screening Period) ≤7 will be eligible for randomization
    1. Presencia de un progenitor/tutor legal capaz de dar su consentimiento para su participación. Progenitor/cuidador/tutor legal que pueda completar las evaluaciones requeridas a lo largo del estudio. Se obtendrá el consentimiento/asentimiento del paciente si tiene 8 años de edad o más y tiene la capacidad mental para comprender y firmar un formulario de consentimiento/asentimiento por escrito y/o dar su asentimiento verbal
    2. Hombres y mujeres entre:
    a. Fase II: 12 y 65 años de edad (inclusive) en el momento del consentimiento/asentimiento
    b. Fase III: 8 a 65 años de edad (inclusive) en el momento del consentimiento/asentimiento
    3. Documentación del diagnóstico genéticamente confirmado de SPW
    4. Si un cuidador ayuda a rellenar el HQ-CT u otros cuestionarios, el mismo cuidador ha de estar disponible para rellenar el cuestionario a lo largo del estudio
    5. Si se trata de una mujer, no debe ser fértil (definiéndose en este caso como estar en la premenarquía o ser estéril quirúrgicamente [ligadura de trompas, ooforectomía bilateral o histerectomía]) o bien debe utilizar uno de los siguientes métodos anticonceptivos aceptables desde el punto de vista médico hasta 4 semanas después de la última dosis de RAD011 o placebo:
    a. Método de doble barrera (es decir, preservativo más capuchón oclusivo [diafragma o capuchón cervical/vaginal], preservativo o capuchón oclusivo más espermicida)
    b. Métodos hormonales como los anticonceptivos orales, implantables, inyectables, anillo vaginal o parche transdérmico en una dosis estable durante un mínimo de 1 ciclo completo (basándose en el periodo del ciclo menstrual habitual de la paciente) antes de la administración del PI
    c. Dispositivo intrauterino (DIU) o sistema intrauterino de liberación de hormonas (SIU)
    d. Si no está usando anticonceptivos hormonales o un DIU/SIU, entonces todos los varones que sean pareja de las pacientes mientras dure el estudio deberán haberse hecho una vasectomía y haber recibido posteriormente una evaluación médica del éxito de la intervención
    6. En caso de ser un paciente varón, debe haberse hecho la vasectomía y haber recibido una prueba clínica del éxito de la intervención, o bien aceptar utilizar un método anticonceptivo aprobado (método de doble barrera como se describe en los Criterios de Inclusión 5, que en caso de tener pareja femenina la mujer tenga puesto un DIU/SIU [puesto desde al menos 12 semanas antes del tratamiento], tomar anticonceptivos orales, ser quirúrgicamente estéril o que haya pasado 2 años desde la menopausia) y acceda a usar este método durante 4 semanas tras la última administración de RAD011 o placebo.
    7. Si está recibiendo hormonas del crecimiento, terapia psicotrópica, tratamientos metabólicos que pudieran afectar al apetito (incluida la metformina) y otros tratamientos que incluyan hormona tiroidea, deben estar tomando la misma medicación y posología estable durante al menos 90 días antes del consentimiento/asentimiento
    8. Cualquier intervención no médica (como terapia de orientación, modificación de la conducta) debe ser estable durante al menos 90 días antes del consentimiento/asentimiento
    9. La elegibilidad según HQ-CT será calculada automáticamente en el sistema de captura de datos electrónica (EDC):
    a. Visita 2
    i. Los pacientes con una puntuación HQ-CT media ≥13 (de la Visita 1 y la Visita 2) serán aptos para continuar en el periodo de tolerabilidad
    b. Visita 5
    i. Los pacientes con una puntuación HQ-CT media ≥13 (de la Visita 3, Visita 4 y Visita 5) serán aptos para la aleatorización, y
    ii. Los pacientes con una reducción en la puntuación HQ-CT (desde el periodo de tolerabilidad hasta el periodo de selección) ≤7 serán aptos para la aleatorización
    E.4Principal exclusion criteria
    1. Hypersensitivity or intolerance to CBD, or any other excipients used in the RAD011 preparation
    2. Known use of cannabis or cannabinoid containing products (including topical products) within 90 days prior to consent/assent
    3. History of chronic liver disease, such as cirrhosis or chronic hepatitis due to any cause
    4. Positive urine test for drugs of abuse, including tetrahydrocannabinol (THC), or known history of drug, alcohol, or substance abuse
    5. Use of prescription or over-the-counter weight loss agents within 90 days prior to consent/assent
    6. Implementation of new food restrictions or environmental restrictions within 90 days of consent/assent
    7. Any significant comorbid condition or disease:
    a. Respiratory disease, heart disease, or psychiatric disorder which in the opinion of the Investigator would preclude the patient from participating or
    b. Uncontrolled type 1 or type 2 diabetes as determined by the Investigator or
    c. Clinically significant ECG abnormalities or other evidence of clinically significant heart disease as determined by the Investigator or
    d. Uncontrolled sleep apnea as determined by the Investigator or
    e. Neutropenia with neutrophil counts <1,000 /microL (grade 3 or grade 4 neutropenia as defined by CTCAE v5.0) or
    f. History or presence of gastrointestinal disorders or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs taken orally as determined by the Investigator
    8. QT interval corrected for heart rate (HR) according to Fridericia's formula (QTcF) meeting the following criteria:
    a. For males and females aged 8 to <20 years: QTcF >439 msec
    b. For males aged 20 to 65 years: QTcF >450 msec
    c. For females aged 20 to 65 years; QTcF >470 msec
    9. At consent/assent, patients with age-matched hypertensive levels of systolic and/or diastolic blood pressure may be excluded at the Investigator’s discretion if deemed to be in the best interest of the patient.
    10. Pregnant (determined by a positive serum pregnancy test) or lactating female
    11. Unwillingness or inability to follow the procedures outlined in the protocol
    12. Estimated glomerular filtration rate <30 mL/min/1.73m2 or protein/creatinine ratio ≥0.4
    13. Bilirubin >1.5 × upper limit of normal (ULN), or aspartate aminotransferase (AST), alanine aminotransferase (ALT) >3 × ULN, or international normalized ratio (INR) >1.5 × ULN
    14. Patient judged by the Investigator or Sponsor (or designee) as unable to comply with the treatment protocol, including appropriate supportive care, follow up, and research tests
    15. Other genetic, hormonal, chromosomal, cognitive, or behavioral impairment
    16. If living in a group home, patient spends less than 25 waking hours with their caregiver per week
    17. Significant risk of committing suicide based on history, routine psychiatric examination, or based on the Investigator's judgment
    18. Participation in any other study involving an investigational product or device within 4 weeks or 5 half-lives (whichever is longer) of consent/assent or longer as required by local regulations
    1. Hipersensibilidad o intolerancia al CBD o a cualquier otro excipiente utilizado en la preparación de RAD011
    2. Uso conocido de productos que contengan cannabis o cannabinoides (incluidos productos de uso tópico) en los 90 días anteriores al consentimiento/asentimiento
    3. Historial de enfermedad hepática crónica, como cirrosis o hepatitis crónica por cualquier causa
    4. Test de orina positivo para abuso de drogas, incluyendo tetrahidrocannabinol (THC) o historial conocido de abuso de drogas, alcohol o sustancias
    5. Uso de productos para perder peso, con o sin receta, en los 90 días anteriores al consentimiento/asentimiento
    6. Implementación de restricciones alimentarias o ambientales en los 90 días anteriores al consentimiento/asentimiento
    7. Cualquier condición o enfermedad comórbida significativa:
    a. Enfermedad respiratoria, enfermedad cardíaca o trastorno psiquiátrico que, según la opinión del investigador, podría impedir la participación del paciente o
    b. Diabetes tipo 1 o tipo 2 no controlada según lo determine el investigador o
    c. Anormalidades en el ECG clínicamente significativas u otra evidencia de enfermedad cardíaca clínicamente significativa según la opinión del investigador o
    d. Apnea del sueño no controlada según lo determinado por el investigador o
    e. Neutropenia con recuento de neutrófilos <1.000/microl (neutropenia de grado 3 o grado 4 según lo definido por CTCAE v5.0) o
    f. Historial o presencia de trastornos gastrointestinales o cualquier otra condición conocida que interfiera en la absorción, distribución, metabolismo o excreción de los fármacos administrados oralmente, según la opinión del investigador
    8. Intervalo QT corregido para el ritmo cardíaco de acuerdo a la fórmula de Fridericia (QTcF), que cumpla con los siguientes criterios:
    a. Para hombres y mujeres de 8 a <20 años de edad: QTcF >439 mseg
    b. Para hombres de 20 a 65 años de edad: QTcF >450 mseg
    c. Para mujeres de 20 a 65 años de edad: QTcF >470 mseg
    9. En el consentimiento/asentimiento, los pacientes con unos niveles de hipertensión de la tensión arterial sistólica y/o diastólica acordes a su edad pueden quedar excluidos si el investigador considera que es lo mejor para el paciente.
    10. Mujer embarazada (determinado por un test de embarazo en suero positivo) o en periodo de lactancia
    11. Falta de disposición o incapacidad para seguir los procedimientos descritos en el protocolo
    12. Tasa de filtración glomerular estimada <30 ml/min/1,73 m2 o ratio de proteínas/creatinina ≥0,4
    13. Bilirrubina >1,5 veces el Límite Superior de la Normalidad (LSN), o aspartato aminotransferasa (AST), alanina aminotransferasa (ALT) >3 veces LSN, o Ratio Normalizado Internacional (RNI) >1,5 veces LSN
    14. Paciente que a juzgar por el investigador o el promotor (o una persona designada) sea incapaz de cumplir con el protocolo del tratamiento, incluyendo un apropiado servicio de apoyo, seguimiento y pruebas de la investigación
    15. Otros impedimentos genéticos, hormonales, cromosomales, cognitivos o conductuales
    16. Si vive en una residencia, el paciente pasa menos de 25 horas de vigilia a la semana con su cuidador
    17. Riesgo significativo de suicidio basándose en su historial, examen psiquiátrico rutinario o según la opinión del investigador
    18. Participación en otro estudio con un medicamento o producto en investigación a menos de 4 semanas o 5 vidas medias (lo que sea más largo) del consentimiento/asentimiento o más si así lo exigen las regulaciones locales
    E.5 End points
    E.5.1Primary end point(s)
    - Change in HQ-CT scores from Baseline through End of Study/Week 34 Visit for RAD011 compared to placebo
    Cambio en las puntuaciones HQ-CT desde el momento basal hasta la visita de final del estudio/Semana 34 para RAD011 comparado con placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline through End of Study/Week 34 Visit
    Desde el momento basal hasta la visita de final del estudio/Semana 34
    E.5.2Secondary end point(s)
    - Change in PWS-associated Irritability from Baseline through End of Study/Week 34 Visit using the Aberrant Behavior Checklist (ABC) questionnaire – Irritability subscale (ABC-I) for RAD011 compared to placebo
    - Change in hyperphagia as defined by the Clinician Global Impression of Change (CGI-C) in Hyperphagia through End of Study/Week 34 Visit
    - Change in Clinician Global Impression of Severity (CGI-S) of Hyperphagia Scale from Baseline through End of Study/Week 34 Visit
    - Cambio en la irritabilidad asociada al SPW desde el momento basal hasta la visita de fin del estudio/Semana 34 usando el Cuestionario de Conductas Anómalas (ABC); subescala de Irritabilidad (ABC-I) para RAD011 comparado con placebo
    - Cambio en la hiperfagia según lo definido en la Escala de Impresión Clínica Global del Cambio (CGI-C) en la hiperfagia hasta la visita de fin del estudio/semana 34
    - Cambio en la Escala de Impresión Clínica Global de la Gravedad (CGI-S) de la hiperfagia desde el momento basal hasta la visita de fin del estudio/semana 34
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Baseline through End of Study/Week 34 Visit for all secondary endpoints.
    Desde el momento basal hasta la visita de fin del estudio/semana 34 para todos los criterios secundarios.
    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) 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) Yes
    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 trial6
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Canada
    United States
    France
    Italy
    Sweden
    United Kingdom
    Spain
    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 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: 163
    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: 25
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 138
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    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
    - Adult patients unable to decide autonomously
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 220
    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)
    All patients completing the End of Study Visit may be offered enrollment in a long-term extension study. Otherwise, patients will be treated as per standard of care.
    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 Decision2022-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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