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    Summary
    EudraCT Number:2014-002594-11
    Sponsor's Protocol Code Number:GWEP1330
    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:2015-03-27
    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 number2014-002594-11
    A.3Full title of the trial
    A double blind, randomized, placebo-controlled, two-part study to investigate the pharmacokinetics, followed by efficacy and safety of GWP42006 as add-on therapy in patients with inadequately controlled focal seizures.
    Estudio aleatorizado doble ciego controlado con placebo, de dos partes para investigar las características farmacocinéticas, seguido de la eficacia y la seguridad de GWP42006 como terapia complementaria en pacientes con crisis epilépticas focales inadecuadamente controladas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of GWP42006 in people with focal seizures
    Estudio con GWP42006 en pacientes con crisis epilépticas focales
    A.4.1Sponsor's protocol code numberGWEP1330
    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 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 number+441223266800
    B.5.5Fax number+441223235667
    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 nameGWP42006 Oral Solution
    D.3.2Product code GWP42006
    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.3.9.2Current sponsor codeGWP42006
    D.3.9.3Other descriptive nameGWP42006
    D.3.9.4EV Substance CodeSUB123082
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Epilepsy
    Epilepsia
    E.1.1.1Medical condition in easily understood language
    Focal Seizures
    Crisis focales
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10016843
    E.1.2Term Focal seizures
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A:
    To determine the pharmacokinetics (PK) of GWP42006 and human metabolites, 7-hydroxy- cannabidivarin (7-OH-CBDV) and 6-hydroxy- cannabidivarin (6-OHCBDV), in the presence of other antiepileptic drugs (AEDs).
    Part B:
    To evaluate the efficacy of GWP42006, compared with placebo, as add-on therapy to treat inadequately controlled focal seizures.
    Parte A:
    Determinar las características farmacocinéticas (PK) de GWP42006 y los metabolitos humanos, 7-hydroxi-cannabidivarin (7-OH-CBDV) y 6-hydroxi-cannabidivarin (6-OH-CBDV), en presencia de otros fármacos antiepilépticos (FAEs).
    Parte B:
    Evaluar la eficacia de GWP42006, comparado con placebo, como terapia complementaria para el tratamiento de crisis epilépticas focales inadecuadamente controladas.
    E.2.2Secondary objectives of the trial
    Part A:
    • To evaluate the safety and tolerability of GWP42006 compared with placebo, in the presence of other AEDs.
    • To evaluate effects of GWP42006 on plasma concentrations of concomitant AEDs.
    Part B:
    • To evaluate the effect of GWP42006 compared with placebo on other efficacy measures.
    • To evaluate the safety and tolerability of GWP42006 compared with placebo.
    • To evaluate the effect of GWP42006 on health utilization compared with placebo.
    • To evaluate the effects of GWP42006 on cognitive function.
    • To determine trough plasma concentrations of GWP42006, 7-OH-CBDV and 6-OH-CBDV, following multiple doses of GWP42006.
    • To evaluate effects of GWP42006 on plasma concentrations of concomitant AEDs.
    Parte A:
    •Evaluar la seguridad y la tolerabilidad de GWP42006 comparado con placebo, en presencia de otros FAEs.
    •Evaluar los efectos de GWP42006 sobre las concentraciones plasmáticas de FAEs concomitantes.
    Parte B:
    •Evaluar el efecto de GWP42006 comparado con placebo sobre otras mediciones de eficacia.
    •Evaluar la seguridad y la tolerabilidad de GWP42006 comparado con placebo.
    •Evaluar el efecto de GWP42006 sobre la utilización de asistencia sanitaria comparado con placebo.
    •Evaluar los efectos de GWP42006 sobre la función cognitiva.
    •Determinar mediante concentraciones plasmáticas de GWP42006, 7-OH-CBDV y 6-OH-CBDV, después de tomar dosis múltiples de GWP42006.
    •Evaluar los efectos de GWP42006 sobre las concentraciones plasmáticas de FAEs concomitantes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient must be willing and able to give informed assent/consent for participation in the study.
    • Male or female aged between 18 and 65 years, inclusive.
    • Well-documented history of focal epilepsy, with focal seizures as the primary seizure type, compatible electroencephalogram and clinical history.
    • Documented CT/MRI that shows no progressive neurologic abnormality.
    • Has focal seizures despite prior treatment with at least two AEDs (whether as monotherapies or in combination).
    • Patient is willing to keep any factors expected to affect seizures stable (such as the level of alcohol consumption and smoking).
    • Patient is able (in the investigators opinion) and willing to comply with all study requirements (including accurate diary completion).
    • Patient is willing to allow his or her primary care practitioner and consultant to be notified of participation in the study.

    Part A only
    • Currently treated with one to three AEDs as follows:
    -Group 1 - including Carbamazepine, Phenobarbital or Phenytoin and excluding Valproic Acid (VPA).
    -Group 2 - including VPA and excluding Carbamazepine, Phenobarbital or Phenytoin.
    -Group 3 - excluding VPA, Carbamazepine, Phenobarbital and Phenytoin.
    • All medications or interventions for epilepsy (including ketogenic diet and any neurostimulation devices for epilepsy) must have been stable for two weeks prior to screening and the patient is willing to maintain a stable regimen throughout the study.

    Part B only
    • Currently treated with one to three AEDs.
    • All medications or interventions for epilepsy (including ketogenic diet) must have been stable for one month prior to screening and the patient is willing to maintain a stable regimen throughout the study.
    •El paciente debe estar dispuesto y ser capaz de dar su consentimiento informado para participar en el estudio.
    •El paciente debe ser hombre o mujer de entre 18 y 65 años de edad, inclusive.
    •El paciente debe tener un historial documentado de epilepsia focal, con ataques focales como el principal tipo de convulsión, electroencefalograma e historial clínico compatibles.
    •Tomografía computarizada (CT)/resonancia magnética (MRI) documentadas que no muestren ninguna anormalidad neurológica progresiva.
    •Tiene ataques focales a pesar de haber recibido previamente tratamientos con al menos dos FAEs (tanto como monoterapia o en combinación).
    •El paciente está dispuesto a mantener estable cualquier factor que se espere afecte los ataques (por ejemplo el nivel de consumo de alcohol y tabaco).
    •El paciente es capaz (en la opinión del investigador) y está dispuesto a cumplir todos los requerimientos del estudio (incluyendo el registro exacto de información en el diario).
    •El paciente debe estar dispuesto a permitir que se notifique su participación en el estudio a su médico de atención primaria y especialista.
    Parte A solo :
    •El paciente debe de estar tomando de uno a tres FAEs, de la siguiente manera:
    -Grupo 1 - incluyendo Carbamazepina, Fenobarbital o Fenitoína y excluyendo Ácido Valproico (VPA).
    -Grupo 2 - incluyendo VPA y excluyendo Carbamazepina, Fenobarbital o Fenitoína.
    -Grupo 3 - excluyendo VPA, Carbamazepina, Fenobarbital y Fenitoína.
    •Todos los medicamentos o las intervenciones para la epilepsia (incluyendo la dieta cetogénica y los dispositivos de neuroestimulación para la epilepsia) deben haber sido estables durante dos semanas antes de la selección y el paciente debe estar dispuesto a mantener un régimen estable durante todo el estudio.

    Parte B solo :
    •El paciente debe de estar tomando de uno a tres FAEs.
    •Todos los medicamentos o las intervenciones para la epilepsia (incluyendo la dieta cetogénica) deben haber sido estables durante un mes antes de la selección y el paciente debe estar dispuesto a mantener un régimen estable durante todo el estudio.
    E.4Principal exclusion criteria
    •Time of onset of epilepsy treatment is less than two years prior to enrolment.
    •Episode(s) of status epilepticus during one year prior to screening.
    •History of pseudo-seizures.
    •Patient has clinically significant unstable medical conditions other than epilepsy.
    •Patient has an illness in the four weeks prior to screening or randomization, other than epilepsy, which in the opinion of the investigator would affect seizure frequency.
    •Patient has, in the investigator’s opinion, clinically significantly abnormal laboratory values.
    •Patient has significantly impaired hepatic function at Visit 1 (ALT >5 X ULN or TBL >2 X ULN) OR the ALT or AST >3 X ULN and TBL >2 X ULN (or INR >1.5).
    •In the opinion of the investigator the patient has clinically significant abnormalities in the 12-lead electrocardiogram (ECG) measured at screening or randomization or any concurrent cardiovascular conditions, which will interfere with the ability to read their ECGs.
    •Active suicidal plan/intent in the past six months, or a history of suicide attempt in the last two years, or more than one lifetime suicide attempt.
    •Patient has a history or presence of alcohol or substance abuse within the two years prior to screening 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 cannabinoid based medications within the three months prior to screening and is unwilling to abstain for the duration for the study.
    •Patient has taken St John’s Wort in the two weeks prior to screening and/or is unwilling to abstain throughout the study.
    •Any known or suspected hypersensitivity to cannabinoids, sesame oil or any of the excipients of the IMP(s).
    •Female patients of child bearing potential and male patients whose partner is of child bearing potential, unless willing to ensure that they and/or their partner use a highly effective method of contraception.
    •Female patient who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
    •Patients who have received an IMP within the 12 weeks prior to the screening visit.
    •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 the patient’s ability to participate in 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.
    •Unwilling to abstain from donation of blood during the study.
    •Travel outside the country of residence planned during the study.
    •Patients previously randomized into this study.
    •Patient has consumed grapefruit or grapefruit juice three days prior to randomization and/or unwilling to abstain in the three days prior to PK sampling visits.
    Part B only
    •Vagus Nerve Stimulation, Deep Brain Stimulation, Responsive Neurostimulator System or other epilepsy neurostimulation device have been implanted or activated less than one year prior to screening, and/or stimulation parameters have been stable for less than one month, and/or battery life of unit not anticipated to extend for duration of trial.
    •El periodo de inicio del tratamiento epiléptico es inferior a dos años antes de la participación en el estudio.
    •Episodio(s) de estado epiléptico durante un año antes de la selección.
    •Historial de crisis pseudoepilépticas.
    •El paciente sufre alguna condición médica inestable clínicamente significativa, exceptuando epilepsia.
    •El paciente ha sufrido alguna enfermedad en las cuatro semanas previas a la visita de selección o aleatorización, exceptuando la epilepsia, que, según la opinión del investigador podría afectar la frecuencia de las crisis.
    •Si, según la opinión del investigador, el paciente tiene valores de laboratorio anormales que son clínicamente significativos.
    •El paciente sufre disfunción hepática importante en la Visita 1 (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).
    •Si, según la opinión del investigador el paciente sufre alguna anormalidad clínica significativa detectada en el electrocardiograma de 12 derivaciones (ECG) durante la visita de selección o aleatorización o alguna afección cardiaca concomitante que podría interferir con la capacidad para evaluar los ECG del paciente.
    •El paciente ha tenido algún plan/intención suicida en los últimos seis meses o tiene historial de comportamiento suicida en los últimos dos años o más de un intento suicida durante su vida.
    •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 o medicinal o medicamentos a base de cannabinoides tres meses antes de la selección para el estudio y no está dispuesto a abstenerse durante la duración del estudio.
    •El paciente ha tomado hierba de San Juan en las dos semanas antes de la visita de selección y/o es reacio a abstenerse de tomarla durante todo el estudio.
    •El paciente sufre o se sospecha que sufre alguna hipersensibilidad conocida a los cannabinoides, aceite de sésamo o a alguno de los excipientes de los MI.
    •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 un método anticonceptivo altamente eficaz.
    •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 recibido algún MI en las 12 semanas anteriores a la visita de selección.
    •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.
    •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.
    •El paciente ha tomado pomelo o zumo de pomelo tres días antes de la aleatorización y/o es reacio a abstenerse en los tres días previos a las visitas de toma de muestra para la PK.
    Parte B solo:
    •Estimulación del nervio vago, estimulación cerebral profunda, sistema neuroestimulador responsivo o tiene implantado o activado algún otro dispositivo neuroestimulador durante menos de un año antes de la visita de selección, y/o los parámetros de estimulación han permanecido estables durante menos de un mes, y/o no se espera que la autonomía de la batería de la unidad dure la totalidad del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Part A - Primary endpoint is the plasma concentrations of GWP42006, 7-OHCBDV and 6-OH-CBDV with the aim of defining Cmax, Cmin, tmax, AUC0-t, AUC0-inf, and t1/2.

    Part B - Primary endpoint is the mean percentage change from baseline to the end of treatment in focal seizure frequency in patients taking GWP42006 compared to placebo.
    Parte A:
    Concentraciones plasmáticas de GWP42006, 7-OH-CBDV y 6-OH-CBDV con el objetivo de definir Cmax, Cmin, tmax, AUC0-t, AUC0-inf y t1/2.
    Parte B:
    Porcentaje medio de cambio en la frecuencia de crisis focales desde el periodo basal hasta el final del tratamiento en pacientes que han tomado GWP42006 comparado con el placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A:
    •Visit A2 - pre-IMP-dose and 30min, 1h, 2h, 4h and 8h after IMP dose.
    •Visit A4 - pre-IMP-dose and 30min, 1h, 2h, 4h and 8h after IMP dose.
    •Visit A5 - 24 +/- 6h after last IMP dose.
    •Visit A6 - 72 +/- 24h after last IMP dose.
    Part B:
    •Baseline (Visit B1 to B2) and last 28 days of the evaluable period
    Parte A :
    - Visita A2. Pre-MI-dosis y 30min, 1h, 2h, 4h y 8h despues de la dosis del MI.
    - Visita A4. Pre-MI-dosis y 30min, 1h, 2h, 4h y 8h despues de la dosis del MI.
    •Visita A5 - 24 +/- 6h despues de la última dosis de MI.
    •Visita A6 - 72 +/- 24h despues de la última dosis de MI.
    Parte B:
    •Selección (de Visita B1 a B2) y los últimos 28 dias del periodo evaluable.
    E.5.2Secondary end point(s)
    The secondary endpoints for Part A are:
    • Safety and tolerability (adverse events [AEs], clinical laboratory testing, vital signs)
    • Plasma concentrations of concomitant AEDs.

    For Part B, efficacy safety and other endpoints are as follows:
    Efficacy endpoints:

    • Number of patients considered treatment responders defined as those with a ≥25%, ≥50%, ≥75% and 100% reduction in focal seizure frequency.
    • Proportion of patients with a 0-24%, ≥25-50%, ≥50%-74% and ≥75%-100% reduction in focal seizure frequency.
    • Change in seizure subtypes frequency.
    • Change in composite seizure score.
    • Change in number of focal seizure free days.
    • Change in use of rescue medication.
    • Subject Global Impression of Change (SGIC).
    • Physician Global Impression of Change (PGIC).

    Safety and tolerability endpoints:
    • AEs.
    • Clinical laboratory testing.
    • Vital signs.
    • Columbia Suicide Severity Rating Scale (C-SSRS).
    • Cannabis Withdrawal Scale (CWS) score.
    • Abuse liability.

    Other endpoints:
    • Change in number of inpatient hospitalizations or out of visit contact with
    medical staff due to epilepsy.
    • Cognitive assessment scores.
    • Plasma concentrations of GWP42006, 7-OH-CBDV and 6-OH-CBDV.
    • Plasma concentrations of concomitant AEDs.
    Los objetivos secundarios de la parte A son los siguientes.

    •Seguridad y tolerabilidad (acontecimientos adversos [AAs], pruebas clínicas de laboratorio, signos vitales).
    •Concentraciones plasmáticas de FAEs concomitantes.

    Para la parte B, eficacia y seguridad y los otros objetivos son los siguientes :
    Eficacia:
    •Número de pacientes que se ha considerado que han respondido al tratamiento, definido como aquellos que han experimentado una reducción en los ataques focales de un ≥25%, ≥50%, ≥75% y una reducción del 100% en la frecuencia de ataques focales.
    •Proporción de pacientes que han experimentado una reducción en la frecuencia de ataques focales de 0-24%, ≥25-50%, ≥50%-74% y ≥75%-100%.
    •Cambio en la frecuencia de subtipos de ataques.
    •Cambio en la puntuación de ataques compuestos.
    •Cambio en el número de días sin ataques focales.
    •Cambio en el uso de medicación de rescate.
    •Cambio en la impresión general del cambio del paciente (SGIC).
    •Cambio en la impresión general del cambio del médico (PGIC).
    Seguridad y tolerabilidad:
    •AAs.
    •Pruebas clínicas de laboratorio.
    •Signos vitales.
    •Escala de calificación de la severidad del suicidio de Columbia (C-SSRS).
    •Puntuación en la escala de abstinencia al cannabis (CWS).
    •Propensión al abuso del uso del fármaco.
    Otras:
    •Cambio en el número de hospitalizaciones o contacto fuera de horas con personal médico, asociados con la epilepsia.
    •Puntuaciones de las evaluaciones cognitivas.
    •Concentraciones plasmáticas de GWP42006, 7-OH-CBDV y 6-OH-CBDV.
    •Concentraciones plasmáticas de FAEs concomitantes
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A:
    •Safety and tolerability - Visit A1 to visit A7
    •AEDs - Visits A2(baseline) and A4
    Part B:
    •Safety and tolerability - Visit B1 to visit B9
    •Efficacy - Baseline (Visit B1 to B2) and last 28 days of the evaluable period; Visit B7 for PGIC and SGIC.
    •Other endpoints - Visits B2 (baseline) and B7; Visit B7for plasma concentrations of GWP42006 and metabolites.
    Parte A :

    - Seguridad y tolerabilidad- de Visita A1 a visita A7.
    - FAES- Visita A2 (selección) y A4.
    Parte B :
    - Seguridad y tolerabilidad- de Visita B1 a visita B9.
    - Eficacia. Selección (de visita B1 a B2) y los últimos 28 días del periodo evaluable. Visita B7 para PGIC y SGIC.
    - Otros objetivos :
    visita B2 (selección) y B7, visita B7 para concentraciones plasmáticas de GWP2006 y metabolitos.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic 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) 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 trial8
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 127
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 130
    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)
    Normal standard of care will resume as clinical evidence of the efficacy of GWP42006 in this population has yet to be determined.
    Tras su finalización en el ensayo, los pacientes reanudarán su asistencia médica habitual debido a que la
    eficacia clinica de GWP42006 en esta población aun no se ha determinado.
    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 Decision2015-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-01
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