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    Summary
    EudraCT Number:2020-002819-21
    Sponsor's Protocol Code Number:GWND19189
    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:2022-01-03
    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 number2020-002819-21
    A.3Full title of the trial
    An exploratory, Phase 2, randomized, double-blind, placebo-controlled trial to investigate the safety and efficacy of cannabidiol oral solution (GWP42003-P; CBD-OS) in children and adolescents with Autism Spectrum Disorder.
    Ensayo exploratorio, de fase II, aleatorizado, doble ciego y controlado con placebo para investigar la seguridad y la eficacia de la solución oral de
    canabidiol (GWP42003-P; CBD-OS) en niños y adolescentes con trastorno del espectro autista
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety and Efficacy Study of GWP42003-P (Cannabidiol; CBD) in Children and Young Adults with Autism Spectrum Disorder.
    Un estudio sobre la seguridad y eficacia de GWP42003-P (Cannabidiol; CBD) en niños y adolescente con trastorno del espectro autista.
    A.4.1Sponsor's protocol code numberGWND19189
    A.5.4Other Identifiers
    Name:IND NumberNumber:150775
    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 SponsorGW Research Ltd
    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 supportGW Research Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGW Research Ltd
    B.5.2Functional name of contact pointGW Research Ltd Switchboard
    B.5.3 Address:
    B.5.3.1Street AddressSovereign House, Vision Park, Chivers Way
    B.5.3.2Town/ cityHiston, Cambridge
    B.5.3.3Post codeCB24 9BZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441223266800
    B.5.5Fax number441223235667
    B.5.6E-mailinfo@gwpharm.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 Yes
    D.2.1.1.1Trade name CBD Oral solution, is known as Epidyolex and is the approved name in the EU
    D.2.1.1.2Name of the Marketing Authorisation holderGW Pharma B.V (International)
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCannabidiol (CBD)
    D.3.2Product code GWP42003-P
    D.3.4Pharmaceutical form Oral drops, solution
    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.3.9.2Current sponsor codeGWP42003-P
    D.3.9.3Other descriptive nameCANNABIDIOL
    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 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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Autism Spectrum Disorder (ASD)
    Trastorno del espectro autista
    E.1.1.1Medical condition in easily understood language
    Autism
    Autismo
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063844
    E.1.2Term Autism spectrum disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of GWP42003-P, compared with placebo, in reducing symptom severity in children with ASD.

    To evaluate the safety of GWP42003-P, compared with placebo, in children with ASD.
    Evaluar la eficacia de GWP42003-P, en comparación con placebo, en la reducción de la gravedad de los síntomas en niños con trastorno del espectro
    autista (TEA)

    Evaluar la seguridad de GWP42003-P, en comparación con placebo, en niños con TEA
    E.2.2Secondary objectives of the trial
    • To evaluate changes in anxiety
    • To evaluate changes in repetitive behavior
    • To evaluate the effects in caregiver quality of life
    • To evaluate the PK/pharmacodynamic relationship of GWP42003-P and its metabolites
    • To evaluate performance in a standardized interactions task (at selected sites)
    • To evaluate speech (at selected sites)
    • Evaluar los cambios en la ansiedad
    • Evaluar los cambios en las conductas repetitivas
    • Evaluar los efectos en la calidad de vida del cuidador
    • Evaluar la relación FC/farmacodinámica de GWP42003-P y sus metabolitos
    • Evaluar el rendimiento en una tarea de interacciones estandarizadas (en centros seleccionados)
    • Evaluar el habla (en centros seleccionados)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the trial, patients must fulfill ALL of the following criteria:
    • Male or female aged 6 to 17 years (inclusive).
    • Patient weight is at least 12 kg.
    • Patients (if possessing adequate understanding, in the investigator’s opinion) and their parent(s)/legal representative are willing and able to give informed assent and consent for participation in the trial.
    • Patient and their caregiver are willing and able (in the investigator’s opinion) to comply with all trial requirements.
    • Patient has a diagnosis of ASD as per DSM-5 criteria for ASD, confirmed by ADOS-2 criteria (conducted within 2 years at the trial site or at screening by a qualified assessor). Note: During special circumstances (e.g., COVID-19 pandemic) where the ADOS-2 cannot be performed due to site restrictions (e.g., mandatory use of face masks) and an ADOS-2 conducted within 2 years at the trial site by a qualified assessor is not available, eligibility can be confirmed using: 1) an ADOS-2 performed within 2 years by a qualified assessor(external to the site); 2) if 1) is not available, eligibility may be confirmed using the ADI-R at screening.
    • CGI-S > or = 4 (moderately ill) at screening and randomization.
    • ABC-I subscale score ≥ 15 at screening.
    • IQ > or = 70 at screening, or measured within 1 year of screening, using WASI-II.
    • All medications or interventions (including psychosocial interventions, dietary supplements, probiotics, speech therapy, etc.) for ASD related symptoms must have been stable for 4 weeks prior to screening and randomization, and the patient/caregiver should be willing to maintain a stable regimen throughout the trial.
    • Patients must have the ability to swallow the IMP, provided as a liquid solution.
    • Patient and/or parent(s)/legal representative is willing to allow the responsible authorities to be notified of participation in the trial, if mandated by local law.
    • Patient and/or parent(s)/legal representative is/are willing to allow the patient’s primary care practitioner (if they have one) and consultant (if they have one) to be notified of participation in the trial if the primary care practitioner/consultant is different from the investigator.
    Para la inclusión en el ensayo, los pacientes deben cumplir TODOS los
    criterios siguientes:
    • Hombre o mujer de 6 a 17 años (ambos incluidos).
    • El paciente pesa al menos 12 kg.
    • Los pacientes (si tienen un buen nivel de entendimiento, en opinión del investigador) y su(s) progenitor(es)/su representante legal está(n) dispuesto(s) a y es (son) capaz (capaces) de dar su asentimiento informado y su consentimiento informado para participar en el ensayo.
    • El paciente y su cuidador están dispuestos a y son capaces (en opinión del investigador) de cumplir con todos los requisitos del ensayo.
    • El paciente tiene un diagnóstico de TEA según los criterios DSM-5 para TEA, confirmado por los criterios ADOS-2 (realizado en el plazo de 2 años en el centro del ensayo o en la selección por un evaluador cualificado). Nota: Durante circunstancias especiales (p. ej., la pandemia de COVID-19) en las que los criterios ADOS-2 no puedan realizarse debido a restricciones del centro (p. ej., uso obligatorio de mascarillas faciales) y ADOS-2 realizados en el plazo de 2 años en el centro del ensayo por un evaluador cualificado no estén disponibles, la idoneidad puede confirmarse mediante: 1) ADOS-2 realizados en el plazo de 2 años por un evaluador cualificado (externo al centro); 2) si 1) no está disponible, la idoneidad se puede confirmar mediante ADI-R en la selección.
    • CGI-S > o = 4 (moderadamente enfermo) en la selección y la aleatorización.
    • Puntuación de la subescala ABC-I ≥15 en la selección.
    • CI > o =70 en la selección, o medido en el año anterior a la selección, utilizando WASI-II.
    • Todos los medicamentos o todas las intervenciones (incluidas intervenciones psicosociales, complementos alimenticios, probióticos, terapia del habla, etc.) para los síntomas relacionados con TEA deben haber sido estables durante 4 semanas antes de la selección y la aleatorización, y el paciente/cuidador debe estar dispuesto a mantener una pauta posológica estable durante todo el ensayo.
    • Los pacientes deben tener la capacidad de tragar el PEI, proporcionado en forma de solución líquida.
    • El paciente o su(s) progenitor(es)/su representante legal está(n) dispuesto(s) a permitir que las autoridades responsables sean informadas de su participación en el ensayo, si así lo exige la legislación local.
    • El paciente o su(s) progenitor(es)/su representante legal está(n) dispuesto(s) a permitir que el médico de atención primaria del paciente (si tiene uno) y el médico adjunto (si tiene uno) sean informados de la participación en el ensayo si el médico de atención primaria/médico adjunto es diferente del investigador.
    E.4Principal exclusion criteria
    The patient may not enter the trial if ANY of the following apply:
    • Current diagnosis of bipolar disorder, psychosis, schizophrenia, schizoaffective disorder, or major depression (patients with depression in remission may be included).
    • Has a diagnosis other than ASD that dominates the clinical presentation (e.g., ADHD).
    • Has a progressive neurological condition.
    • Seizures in the past 24 weeks.
    • Changes in anticonvulsive therapy within the last 12 weeks.
    • Currently taking more than 2 AEDs.
    • Taking sirolimus, everolimus, temsirolimus, or tacrolimus.
    • Taking clobazam.
    • Taking omeprazole, lansoprazole, tolbutamide, or warfarin.
    • Taking repaglinide, pioglitazone, rosiglitazone, montelukast, bupropion, or efavirenz.
    • Currently using or has used recreational or medicinal cannabis, cannabinoid-based medications (including Sativex®, or Epidiolex®/Epidyolex®) within the 12 weeks prior to screening and is unwilling to abstain for the duration of the trial.
    Patient has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP, such as sesame oil.
    • Patient has moderately impaired hepatic function at screening, defined as serum ALT or AST > 2 × ULN or TBL > 2 × ULN’
    This criterion can only be confirmed once the laboratory results are available; patients enrolled into the trial who are later found to meet this criterion must be screen-failed.
    • Patient is male and fertile (i.e., after puberty unless permanently sterile by bilateral orchidectomy) unless willing to ensure that they use male contraception (condom) or remain sexually abstinent during the trial and for 12 weeks thereafter.
    • Patient is female and of childbearing potential (i.e., following menarche and until becoming postmenopausal for > o = 12 consecutive months unless permanently sterile by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) unless willing to ensure that they use a highly effective method of birth control (e.g., hormonal contraception, intrauterine device/hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence) during the trial and for 12 weeks thereafter.
    • Female patient who is pregnant (positive pregnancy test), lactating or planning pregnancy during the course of the trial or within 12 weeks thereafter.
    • Patient has received an IMP within the 12 weeks prior to the screening visit.
    • Patient had brain surgery or traumatic brain injury within 1 year of screening.
    • Patient has any other significant disease or disorder which, in the opinion of the investigator, may either put the patient, other participants, or site staff at risk because of participation in the trial, may influence the result of the trial, or may affect the patient’s ability to take part in the trial.
    • Any abnormalities identified following a physical examination of the patient that, in the opinion of the investigator, would jeopardize the safety of the patient if they took part in the trial.
    • Any history of suicidal behavior (lifelong) or any suicidal ideation of type 4 or 5 on the C-SSRS in the last 4 weeks or at screening or randomization.
    Patient has donated blood during the past 12 weeks and is unwilling to abstain from donation of blood during the trial.
    • Patient has any known or suspected history of alcohol or substance abuse or positive drugs of abuse test at screening (not justified by a known concurrent medication).
    Patient has previously been randomized into this trial.
    • Patient has plans to travel outside their country of residence during the trial, unless the patient has confirmation that the IMP is permitted in the destination country/state.
    El paciente no podrá participar en el ensayo si se da CUALQUIERA de las siguientes circunstancias:
    • Diagnóstico actual de trastorno bipolar, psicosis, esquizofrenia, trastorno esquizoafectivo o depresión mayor (pueden incluirse pacientes con depresión en remisión).
    • Tiene un diagnóstico distinto de TEA que domina la presentación clínica (p. ej., TDAH).
    • Tiene una afección neurológica progresiva.
    • Convulsiones en las últimas 24 semanas.
    • Cambios en el tratamiento anticonvulsivo en las últimas 12 semanas.
    • Está tomando actualmente más de 2 fármacos antiepilépticos (FAE).
    • Está tomando sirolimús, everólimus, temsirólimus o tacrolimús.
    • Está tomando clobazam.
    • Está tomando omeprazol, lansoprazol, tolbutamida o warfarina.
    • Está tomando repaglinida, pioglitazona, rosiglitazona, montelukast, bupropión o efavirenz.
    • En la actualidad o en el pasado, consumo social o farmacológico del cannabis, medicamentos a base de cannabinoides (incluidos Sativex ® o Epidiolex ® /Epidyolex ®) en las 12 semanas anteriores a la selección y no está dispuesto a renunciar a ello durante el ensayo.
    • El paciente tiene algún tipo de hipersensibilidad conocida o presunta a los cannabinoides o a cualquiera de los excipientes del PEI, como el aceite de sésamo.
    • El paciente presenta función hepática moderadamente deteriorada en la selección, definida como ALT o AST en suero >2 × LSN o BLT >2 × LSN.
    Este criterio solo puede confirmarse una vez que se disponga de los resultados analíticos; los pacientes inscritos en el ensayo que posteriormente se descubra que cumplen este criterio deben considerarse fallos de selección.
    • El paciente es varón y fértil (es decir, después de la pubertad a menos que sea permanentemente estéril mediante orquiectomía bilateral), a menos que esté dispuesto a garantizar que utiliza un anticonceptivo masculino (preservativo) o mantiene la abstinencia sexual durante el ensayo y las 12 semanas siguientes.
    • El paciente es mujer y está en edad fértil (es decir, después de la menarquia y hasta que sea posmenopáusica durante > o = 12 meses consecutivos, a menos que sea permanentemente estéril mediante
    histerectomía, salpingectomía bilateral u ooforectomía bilateral) a menos que esté dispuesta a garantizar que utiliza un método anticonceptivo de alta eficacia (p. ej., anticoncepción hormonal,
    dispositivo intrauterino/sistema liberador de hormonas, ligadura bilateral de trompas, pareja vasectomizada, abstinencia sexual) durante el ensayo y las 12 semanas siguientes.
    • Paciente embarazada (prueba de embarazo positiva), en periodo de lactancia o planificando un embarazo durante el curso del ensayo o en las 12 semanas siguientes.
    • El paciente ha recibido un PEI en las 12 semanas anteriores a la visita de selección.
    • El paciente se sometió una cirugía cerebral o sufrió una lesión cerebral traumática en el plazo de un año anterior a la selección.
    • El paciente tiene alguna otra enfermedad significativa o algún otro trastorno significativo que, en opinión del investigador, puede poner al paciente, a otros participantes o al personal del centro en peligro debido a su participación en el ensayo, puede influir en el resultado del mismo o afectar a la capacidad del paciente para participar en él.
    • Cualquier anomalía identificada tras una exploración física del paciente que, en opinión del investigador, pondría en peligro la seguridad del paciente si participase en el ensayo.
    • Cualquier antecedente de comportamiento suicida (permanente) o cualquier pensamiento suicida de tipo 4 o 5 en la C-SSRS en las últimas 4 semanas o en la selección o aleatorización.
    • El paciente ha donado sangre durante las últimas 12 semanas y no está dispuesto a abstenerse de donar sangre durante el ensayo.
    • El paciente tiene antecedentes conocidos o sospecha de alcoholismo o drogadicción o un resultado positivo en la prueba de consumo de drogas en la selección (no justificado por un medicamento
    concomitante conocido).
    • El paciente se ha aleatorizado previamente a este ensayo.
    • El paciente tiene previsto desplazarse fuera de su país de residencia durante el ensayo, a menos que el paciente tenga confirmación de que el PEI está permitido en el país/estado de destino.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints:
    Behavior
    • ABC Subscales
    Social Communication
    • VABS-3
    Overall Condition
    • CGI-I
    • CGI-S

    Safety Endpoints:
    • AEs.
    • Clinical laboratory parameters.
    • Vital signs.
    • Physical examination procedures.
    • 12-lead ECG.
    • C-SSRS.
    Criterios de valoración de eficacia:
    Comportamiento
    • Subescalas ABC
    Comunicación social
    • VABS-3
    Estado general
    • CGI-I
    • CGI-S

    Criterios de valoración de seguridad:
    • AA.
    • Parámetros analíticos clínicos.
    • Constantes vitales.
    • Procedimientos de exploración física.
    • ECG de 12 derivaciones.
    • C-SSRS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy Endpoints:
    ABC Subscales: Visits 1, 2, 5, 7 & 8
    VABS-3: Visits 2, 5, 7 & 8
    CGI-I: Visits 5, 7 & 8
    CGI-S: Visits 1, 2, 5, 7 & 8)

    Safety Endpoints:
    AEs: at each visit
    Clinical laboratory parameters: Visits 1, 5, 8 (if not tapering) & 9
    Vital signs: Visits 1, 2, 5, 7, 8 & 9
    Physical examination procedures: Visits 1 & 9
    12-lead ECG: Visits 1 & 9
    C-SSRS: Visits 1, 2, 5, 7, 8 & 9
    Criterios de valoración de eficacia:
    Subescalas ABC: Visitas 1, 2, 5, 7 y 8
    VABS-3: Visitas 2, 5, 7 y 8
    CG-I: Visitas 5, 7 y 8
    CG-S: Visitas 1, 2, 5, 6, 7 y 8

    Criterios de valoración de seguridad:
    AA: en cada visita
    Parámetros de laboratorio: Visitas 1, 5 y 8 (si no en descenso) y 9
    Constantes: Visitas 1, 2, 5, 7, 8 y 9
    Exploración física: Visitas 1 y 9
    EGC 12 derivaciones: Visitas 1 y 9
    C-SSRS: Visitas 1, 2, 5, 7, 8 y 9
    E.5.2Secondary end point(s)
    Exploratory Endpoints:

    • PARS
    • RBS-R
    • CarerQoL
    • Explore potential correlations between plasma exposure of GWP42003-P and its metabolites with markers of efficacy
    • BOSCC
    • Speech analytics
    Criterios exploratorios:
    • PARS
    • RBS-R
    • CarerQoL
    • Explorar potenciales correlaciones entre exposición plasmática a GWP42003-P y sus metabolitos con marcadores de eficacia
    • BOSCC
    • Speech analytics
    E.5.2.1Timepoint(s) of evaluation of this end point
    PARS: Visits 2 & 8
    RBS-R: Visits 2, 5, 7 & 8
    CarerQoL: Visits 2 & 8
    Explore potential correlations between plasma exposure of GWP42003-P and its metabolites with markers of efficacy: At study end.
    BOSCC: Visits 2 & 8
    Speech analytics: Visits 2 & 8
    PARS: Visitas 2 y 8
    RBS-R: Visitas 2, 5, 7 y 8
    CarerQoL: Visitas 2 y 8
    Explorar potenciales correlaciones entre exposición plasmática a GWP42003-P y sus metabolitos con marcadores de eficacia: al final del estudio
    BOSCC: Visitas 2 y 8
    Speech analytics: Visitas 2 y 8
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Germany
    Spain
    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
    Last patient last visit or last contact, whichever occurs last.
    Última visita del último paciente o último contacto, lo que ocurra primero
    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: 160
    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: 80
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 80
    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
    Patients who are minors and therefore unable to give consent personally.

    Patients who are affected by a neurodevelopmental disorder (Autism Spectrum Disorder) and therefore may be unable to give consent personally.
    Pacientes menores que no pueden dar el consentimiento personalmente.
    Pacientes afectos de un desorden del desarrollo neurológico (desorden del espectro autista) y por tanto no pueden dar su consentimiento en persona.
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients who are affected by a neurodevelopmental disorder (Autism Spectrum Disorder)
    Pacientes afectos de un desorden del desarrollo neurológico (desorden del espectro autista)
    F.4 Planned number of subjects to be included
    F.4.1In the member state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 160
    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)
    No post-trial access to the IMP will be provided. Post trial treatment and care will be managed by the patient's GP/Doctor/Family Doctor or Hospital, in line with expected normal treatment for ASD.
    No se proporcionará el medicamento en investigación tras la finalización del ensayo. El tratamiento tras el ensayo será según lo prescriba el médico del hospital o médico de atención primaria según estándar de tratamiento para el trastorno del espectro autista
    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 Decision2022-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-20
    P. End of Trial
    P.End of Trial StatusOngoing
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