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    Summary
    EudraCT Number:2014-002939-34
    Sponsor's Protocol Code Number:GWEP1424
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-16
    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 number2014-002939-34
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.
    Estudio aleatorizado doble ciego controlado con placebo para investigar la eficacia y la seguridad del cannabidiol (GWP42003-P) en niños y adultos con Síndromes de Dravet.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome
    Estudio de eficacia y seguridad del cannabidiol (GWP42003-P) en niños y adultos con Síndrome de Dravet.
    A.4.1Sponsor's protocol code numberGWEP1424
    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 Kingdom
    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 AddressPorton Down Science Park
    B.5.3.2Town/ citySalisbury, Wiltshire
    B.5.3.3Post codeSP4 0JQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441980557000
    B.5.5Fax number+441980557111
    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 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 nameCannabidiol (CBD)
    D.3.2Product code GWP42003-P
    D.3.4Pharmaceutical form Oral 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 INNN/A
    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 Yes
    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
    Dravet syndrome
    Síndrome de Dravet
    E.1.1.1Medical condition in easily understood language
    Epilepsy
    Epilepsia
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10073677
    E.1.2Term Severe myoclonic epilepsy of infancy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of GWP42003-P as an adjunctive antiepileptic treatment compared with placebo, with respect to the percentage change from baseline during the maintenance period of the study in convulsive seizure frequency. The dose response effect between two GWP42003-P Dose Levels and placebo will also be explored. Convulsive seizures are defined as tonic-clonic, tonic, clonic or atonic and nonconvulsive seizures as myoclonic, partial or absence.
    Evaluar la eficacia de GWP42003-P como tratamiento antiepiléptico complementario comparado con placebo mediante el porcentaje de cambio en la frecuencia de ataques convulsivos respecto al basal en el periodo de mantenimiento del estudio. También se explorará el efecto dosis-respuesta entre dos niveles de dosis de GWP42003-P y el placebo. Los ataques convulsivos se definen como tonicoclónicos, tónicos, clónicos o atónicos y los ataques no consulvivos como mioclónicos, parciales o de ausencia.
    E.2.2Secondary objectives of the trial
    ?To assess changes from baseline in non-convulsive seizure frequency, usage of rescue medication, number of inpatient hospitalizations due to epilepsy, sleep disruption, daytime sleepiness, quality of life and conduct behavioral and cognitive assessments in patients taking GWP42003-P as an adjunctive treatment, when compared with placebo.
    ?To assess the safety of both GWP42003-P doses when compared with placebo.
    ?Evaluar los cambios en la frecuencia, duración de ataques no convulsivos, respecto al basal, uso de medicación de rescate, número de hospitalizaciones debidas a la epilepsia, alteración del sueño, somnolencia diurna, calidad de vida, el comportamiento adaptivo y la función cognitiva en pacientes que toman GWP42003-P como tratamiento complementario, comparado con el placebo.
    ?Evaluar la seguridad de ambas dosis de GWP42003-P comparado con el placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Patient and/or parent(s)/legal representative must be willing and able to give informed assent/consent for participation in the study.
    ?Patient and their caregiver must be willing and able (in the investigator´s opinion) to comply with all study requirements.
    ?Patient must be male or female aged between two and 18 years (inclusive).
    ? Patient must have a documented history of DS which is not completely controlled by current antiepileptic drugs (AEDs).
    ?Patient must be experiencing four or more convulsive seizures (i.e., tonic-clonic, tonic, clonic, atonic seizures) during the 28-day baseline observation period.
    ?Patient must be taking one or more AEDs at a dose which has/have been stable for at least four weeks.
    ?All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation) must have been stable for four weeks prior to screening and patient and caregiver are willing to maintain a stable regimen throughout the study.
    ?Patient and/or parent(s)/legal representative is willing to allow his or her primary care practitioner and consultant to be notified of participation in the study.
    ?El paciente y/o sus padres/representante legal deben estar dispuestos y ser capaces de dar su consentimiento/asentimiento informado para participar en el estudio (véase la Sección 15.2).
    ?El paciente y su cuidador deben estar dispuestos y ser capaces de (según la opinión del investigador) cumplir con todos los requerimientos del estudio.
    ?El paciente debe ser hombre o mujer de entre dos a 18 años de edad (inclusive).
    ?El paciente debe tener un historial documentado de SD que no esté completamente controlado por los actuales fármacosantiepilépticos ( FAEs).
    ?El paciente debe sufrir cuatro o más ataques convulsivos (es decir, tonicoclónicos, tónicos, clónicos, atónicos) durante el periodo basal de 28 días.
    ?El paciente debe de estar tomando uno o más medicamentos FAE a una dosis estable durante al menos cuatro semanas.
    ?Todos los medicamentos o las intervenciones para la epilepsia (incluyendo la dieta cetogénica o el tratamiento de estimulación del nervio vago) deben haber sido estables durante cuatro semanas antes de la selección y el paciente y el cuidador están dispuestos a mantener un régimen estable durante todo el estudio.
    ?El paciente y/o sus padres/representante legal deben estar dispuestos a permitir que se notifique su participación en el estudio a su médico de atención primaria y especialista.
    E.4Principal exclusion criteria
    ?Patient has clinically significant unstable medical conditions other than epilepsy.
    ?Patient has had clinically relevant symptoms or a clinically significant illness in the four weeks prior to screening or randomization, other than epilepsy.
    ?Patient has clinically significant abnormal laboratory values, in the investigator´s opinion, at screening or randomization.
    ?Patient has clinically relevant abnormalities in the ECG measured at screening or randomization.
    ?Patient has any concurrent cardiovascular conditions which will, in the investigator´s opinion, interfere with the ability to assess their ECGs.
    ?Patient has a history or presence of alcohol or substance abuse within the last two years prior to the study or daily consumption of five or more alcohol-containing beverages.
    ?Patient is currently using, or has in the past used, recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the three months prior to study entry.
    ?Patient is unwilling to abstain from using recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex®) during the study.
    ?Patient has a history of symptoms (e.g., dizziness, light-headedness, blurred vision, palpitations, weakness, syncope) related to a drop in blood pressure due to postural changes.
    ?Patient has ingested alcohol in the 24-hour period prior to the first study visit and/or is unwilling to abstain from drinking alcohol throughout the treatment period.
    ?Patient has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMPs (e.g., sesame oil).
    ?Female patient is of child bearing potential or male patient´s partner is of child bearing potential; unless willing to ensure that they or their partner use effective contraception, for example oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however a male condom should not be used in conjunction with a female condom).
    ?Female patient is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
    ?Patient has been part of a clinical trial involving another IMP in the previous six months.
    ?Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, may influence the result of the study, or affect the patient?s ability to participate in the study.
    ?Patient has significantly impaired hepatic function at screening (Visit 1) or randomization (Visit 2) (Alanine aminotransferase [ALT] >5 x upper limit of normal [ULN] or total bilirubin [TBL] >2 x ULN) OR the ALT or Aspartate aminotransferase (AST) >3 x ULN and (TBL >2 x ULN or international normalized ratio [INR] >1.5). This criterion can only be confirmed once the laboratory results are available; patients randomized into the study who are later found to meet this criterion should be withdrawn from the study.
    ?Following a physical examination the patient has any abnormalities that, in the opinion of the investigator, would prevent the patient from safe participation in the study.
    ?Patient is unwilling to abstain from donation of blood during the study.
    ?There are plans for the patient to travel outside their country of residence during the study.
    ?Patient has previously been randomized into this study.
    ?Any history of suicidal behavior or any suicidal ideation of type four or five on the C-SSRS at screening.
    ?El paciente sufre alguna condición médica inestable clínicamente significativa, exceptuando epilepsia.
    ?El paciente ha sufrido síntomas clínicamente relevantes o una enfermedad clínicamente significativa en las cuatro semanas previas a la visita de selección o aleatorización, exceptuando la epilepsia.
    ?Si, según la opinión del investigador, durante la visita de selección o aleatorización el paciente tiene valores de laboratorio anormales que son clínicamente significativos.
    ?El paciente sufre alguna anormalidad clínica relevante detectada en el ECG durante la visita de selección o aleatorización.
    ?El paciente sufre alguna afección cardiaca concomitante que, en la opinión del investigador, podría interferir con la capacidad para evaluar los ECG del paciente.
    ?El paciente tiene historial o presenta signos de abuso de alcohol u otras sustancias en los últimos dos años antes del estudio o consume diariamente cinco o más bebidas que contienen alcohol.
    ?El paciente utiliza en la actualidad o ha utilizado en el pasado, cannabis recreativo, cannabis medicinal o medicamentos sintéticos a base de cannabinoides (incluyendo Sativex®) tres meses antes de su participación en el estudio.
    ?El paciente no está dispuesto a abstenerse de utilizar cannabis recreativo, cannabis medicinal o medicamentos sintéticos a base de cannabinoides (incluyendo Sativex®) durante el estudio.
    ?El paciente tiene un historial de síntomas (p. ej., vértigo, mareos, visión borrosa, palpitaciones, debilidad, síncope) relacionados con una caída en la presión arterial debida a cambios posturales.
    ?El paciente ha ingerido alcohol 24 horas antes de la primera visita del estudio y/o es reacio a abstenerse de beber alcohol durante el periodo de tratamiento.
    ?El paciente sufre o se sospecha que sufre alguna hipersensibilidad conocida a los cannabinoides o a alguno de los excipientes de los MI (p. ej., al aceite de sésamo).
    ?Una paciente con potencial para procrear o un paciente cuya pareja tenga potencial para procrear, a menos que estén dispuestos a asegurar que tanto ella como su pareja utilizarán métodos anticonceptivos eficaces, por ejemplo anticonceptivos orales, de doble barrera, dispositivos intrauterinos, durante el estudio y tres meses después del estudio (no obstante el condón masculino no debería utilizarse en conjunción con el condón femenino).
    ?Una paciente embarazada, que esté dando pecho o planificando un embarazo durante el transcurso del estudio y tres meses después del estudio.
    ?El paciente ha participado en algún ensayo clínico asociado con algún medicamento en investigación en los seis meses anteriores a este estudio.
    ?Cualquier otra enfermedad o trastorno que, según la opinión del investigador, podría poner en peligro al paciente al participar en el estudio, podría influir en el resultado del estudio o afectar la capacidad del paciente para participar en el estudio.
    ?El paciente sufre disfunción hepática importante en la visita de selección (Visita 1) o en la visita de aleatorización (Visita 2) (alanina aminotransferasa [ALT] >5 x límite superior normal [ULN] o bilirrubina total [TBL] >2 x ULN) O ALT o aspartato aminotransferasa (AST) >3 x ULN y (TBL >2 x ULN o razón internacional normalizada [INR] >1.5). Este criterio solamente puede confirmarse una vez de que estén disponibles los resultados de laboratorio; los pacientes que participen en el estudio y que posteriormente se descubra que cumplen este criterio deberían ser retirados del estudio.
    ?Tras la exploración física el paciente tiene alguna anormalidad que, según la opinión del investigador, pondría en riesgo la participación del paciente en el estudio de forma segura.
    ?El paciente es reacio a abstenerse de donar sangre durante el estudio.
    ?El paciente tiene previsto viajar fuera de su país de residencia durante el estudio.
    ?El paciente ha estado anteriormente aleatorizado en este estudio.
    ?Historial de comportamiento suicida o cualquier ideación suicida de tipo cuatro o cinco en la escala C-SSRS en la visita de selección
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the mean percentage change from baseline in convulsive seizure frequency during the maintenance period (Day 15 to the end of the evaluable period) in patients taking GWP42003-P compared with placebo.
    La variable principal es el porcentaje medio de cambio en la frecuencia de ataques convulsivos respecto al basal, durante el periodo de mantenimiento (día 15 hasta el final del periodo de evaluación) en pacientes que hayan tomado GWP42003-P comparado con el placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessed from Visit 3 to Visit 8 (Day 15 to Day 99).
    Evaluado desde la visita 3 a la visita 8 (del día 15 al día 99).
    E.5.2Secondary end point(s)
    The following endpoints will be compared between the three treatment groups over the 12-week, double-blind maintenance period:
    ?Number of patients experiencing a >25% worsening, -25 to +25% no change, 25-50% improvement, 50-75% improvement or >75% improvement in convulsive seizures from baseline.
    ? Number of patients who are convulsive seizure free.
    ? Percentage changes from baseline in non-convulsive seizure frequency.
    ?Change in types of seizures.
    ?Changes from baseline in duration of seizure subtypes as assessed by the Caregiver Global Impression of Change in Seizure Duration
    (CGICSD).
    ? Changes from baseline in usage of rescue medication.
    ?Changes from baseline in number of inpatient hospitalizations due to epilepsy.
    ? Changes from baseline in Sleep Disruption 0-10 Numerical Rating Scale (0-10 NRS) score.
    ?Changes from baseline in Epworth Daytime Sleepiness Scale (EDSS) score.
    ? Changes from baseline in the Quality of Life in Childhood Epilepsy (QOLCE) score.
    ? Changes from baseline in the Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) score.
    ? Change in cognitive function as measured with a cognitive assessment battery.
    ? Caregiver Global Impression of Change (CGIC).
    The safety profile of GWP42003-P compared with placebo will also be the assessed at each Dose Level by measuring:
    ?Adverse events (AEs).
    ?Vital signs.
    ?Physical examination parameters.
    ?12-lead Electrocardiogram (ECG).
    ?Laboratory parameters.
    ?Columbia-Suicide Severity Rating Scale (C-SSRS) score.
    ?Cannabis Withdrawal Scale (CWS) or Pediatric Cannabinoid Withdrawal Scale (PCWS) score
    ? Abuse liability.
    Durante el periodo de mantenimiento doble ciego de 12 semanas, se compararán las siguientes variables entre los tres grupos de tratamiento:
    ?Número de pacientes que han experimentado un empeoramiento de >25%, ?25 a +25% sin cambio, una mejoría de 25?50%, una mejoría de 50?75% o una mejoría de >75% en la incidencia de ataques convulsivos, respecto al basal.
    ?Número de pacientes sin ataques convulsivos.
    ?Cambio respecto al basal en la frecuencia de ataques no convulsivos
    ?Cambio en el tipo de ataques.
    ?Cambios respecto al basal en la duración de otros tipos de ataques según se haya valorado en la Impresión General del Cuidador del Cambio en la Duración de los Ataques (CGICSD).
    ?Cambio en el uso de medicación de rescate respecto al basal.
    ?Cambio respecto al basal en el número de hospitalizaciones asociadas con la epilepsia
    ?Cambio respecto al basal en la escala de clasificación numérica 0?10 (0?10 NRS) de alteración del sueño. (Sleep Disruption Scale).
    ?Cambio respecto al basal en la escala de somnolencia de Epworth (EDSS).
    ?Cambio respecto al basal en la calidad de vida según se haya medido con Calidad de vida en niños con epilepsia (QOLCE),
    ?Cambio respecto al basal en las escalas de conducta adaptiva de Vineland, segunda edición (Vineland-II),
    ?Cambio respecto al basal en la función cognitiva según se haya medido con una batería de evaluación cognitiva.
    ?Cambio en la impresión general del cambio del cuidador (CGIC).
    Para cada nivel de dosis también se evaluará el perfil de seguridad de GWP42003-P comparado con el placebo, midiendo:
    ?Acontecimientos adversos (AAs).
    ?Signos vitales.
    ?Parámetros del examen físico.
    ?Electrocardiograma de 12 derivaciones (ECG).
    ?Parámetros de laboratorio.
    ?Puntuación en la escala de calificación de la severidad del suicidio de Columbia (C-SSRS).
    ?Puntuación en la escala de abstinencia al cannabis (CWS) o en la escala pediátrica de abstinencia a los cannabinoides (PCWS).
    ?Propensión al abuso del uso del fármaco.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessed from Visit 3 to Visit 8 (Day 15 to Day 99).
    Evaluado desde la Visita 3 hasta la Visita 8 (desde día 15 hasta día 99).
    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 No
    E.6.7Pharmacodynamic No
    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) No
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Israel
    Netherlands
    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
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 120
    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: 40
    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
    Some patients entering this study will be unable to give consent personally due to Mental Disability or Cognitive Impairment. In these cases consent/assent will be sought from patient and/or parent(s)/legal representative.
    Algunos pacientes que se incluyan en el estudio serán incapaces de dar consentimiento informado debido a discapacidad mental o deterioro cognitivo.En estos casos elconsentimiento/asentimiento se obtentrá del pacientey/o padre(s)/representante legal.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 120
    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)
    Following study completion, all patients will be invited to continue to receive GWP42003-P in an open label extension (OLE) study (under a separate protocol).
    Tras la finalización del estudio, se le ofrecerá a todos los pacientes la posibilidad de continuar recibiendo GWP42003-P en un estudio de extensión abierto (OLE) (bajo otro protocolo)
    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 Decision2015-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-09
    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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