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    Summary
    EudraCT Number:2020-003271-18
    Sponsor's Protocol Code Number:GWSP20105
    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:2021-07-05
    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 number2020-003271-18
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis
    Ensayo clínico cruzado de 2 vías, aleatorizado, doble ciego y controlado con placebo para evaluar el efecto de nabiximols solución para pulverización bucal sobre las variables clínicas de espasticidad en pacientes con esclerosis múltiple
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis
    Un ensayo para comprobar la eficacia de nabiximols en el tratamiento de la espacticidad en pacientes con esclerosis múltiple
    A.4.1Sponsor's protocol code numberGWSP20105
    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 Pharma Limited
    B.1.3.4CountryNetherlands
    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 Pharma Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGW Pharma Limited
    B.5.2Functional name of contact pointRegulatory affairs manager
    B.5.3 Address:
    B.5.3.1Street AddressSovereign House, Vision Park, Chivers Way, Histon
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB24 9BZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441223266800
    B.5.5Fax number441223235667
    B.5.6E-mailgwreg@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 Sativex 2,7mg/2,5 mg Solucion para pulverizacion bucal
    D.2.1.1.2Name of the Marketing Authorisation holderGW Pharma Ltd
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameNabiximols - Sativex
    D.3.4Pharmaceutical form Oromucosal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTetrahydrocannabinol Botanical Drug Substance (THC BDS)
    D.3.9.1CAS number 1972-08-3
    D.3.9.3Other descriptive nameDELTA-9-TETRAHYDROCANNABINOL
    D.3.9.4EV Substance CodeSUB27785
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number27
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCannabidiol Botanical Drug Substance (CBD BDS)
    D.3.9.1CAS number 13956-29-1
    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 number25
    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 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 placeboOromucosal spray, solution
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Symptomatic treatment of spasticity in patients with multiple sclerosis (MS)
    Tratamiento sintomático de la espasticidad en pacientes con esclerosis múltiple (EM)
    E.1.1.1Medical condition in easily understood language
    Treatment of muscle spasm in patients with multiple sclerosis (MS)
    Tratamiento del espasmo muscular en pacientes con esclerosis múltiple (EM)
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10028335
    E.1.2Term Muscle spasticity
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system 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 effect of multiple doses of nabiximols compared with placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs (Lower Limb Muscle Tone-6; LLMT-6) in patients with MS
    Evaluar el efecto de dosis múltiples de nabiximols en comparación con placebo sobre un indicador clínico del tono muscular dependiente de la velocidad en las extremidades inferiores (Tono Muscular de las Extremidades Inferiores-6 [Lower Limb Muscle Tone 6, LLMT-6]) en pacientes con EM.
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of multiple doses of nabiximols compared with placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs (Lower Limb Muscle Tone 4; LLMT-4) in patients with MS
    • To evaluate the safety and tolerability of nabiximols after administration of multiple doses
    • To evaluate the pharmacokinetic (PK) profile of nabiximols after administration of multiple doses

    Exploratory Objectives:
    • To evaluate the effect of nabiximols after administration of multiple doses on walking using the Timed 25-Foot Walk (T25FW) test
    • To evaluate the effect of nabiximols after administration of multiple doses on the following patient-reported outcomes:
    − The 11-point Numerical Rating Scale (NRS) spasticity score
    − Daily spasm count
    − The MS Spasticity Scale (MSSS-88) total and subdomain scores
    •Eval el efecto de dosis múltiples de nabiximols en comparación con placebo sobre un indicador clínico del tono muscular dependiente de la velocidad en las extremidades inferiores (Tono Muscular de las Extremidades Inferiores-4)en pacientes con EM.•Eval la seguridad y la tolerabilidad de nabiximols tras la administración de dosis múltiples.•Eval el perfil FC de nabiximols tras la administración de dosis múltiples. Obj Exploratorios:• Eval el efecto de nabiximols tras la administración de dosis múltiples sobre la capacidad ambulatoria determinada mediante la prueba de la marcha cronometrada de 7,62 m (Timed 25-Foot Walk, T25FW). •Eval el efecto de nabiximols tras la administración de dosis múltiples sobre los siguientes resultados notificados por el paciente:−Puntuación de espasticidad en una Escala de Valoración Numérica (EVN) de 11 puntos.− Recuento diario de espasmos.− Puntuaciones en los distintos dominios y total de la Escala de Espasticidad en EM de 88 ítems.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female, aged 18 years or above.
    • Willing and able to give informed consent for participation in the trial.
    • Willing and able (in the investigator’s opinion) to comply with all trial requirements.
    • Has had a diagnosis with any disease subtype of MS, by revised 2017 McDonald criteria, for at least 12 months prior to Visit 1 and is expected to remain stable for the duration of the trial.
    • Has an MAS untransformed score of at least 2 in 2 or more of 6 muscle groups (right knee flexors, left knee flexors, right knee extensors, left knee extensors, right plantar flexors, or left plantar flexors) at Visit 1.
    • If currently receiving approved anti-spasticity therapy, it must be with a stable dosing regimen for at least 30 days prior to Visit 1. The patient must be willing to maintain the same antispasticity medication and not plan to initiate a new course of physiotherapy for the duration of the trial.
    • If currently receiving an approved MS disease-modifying therapy, it must be at a stable dose for at least 3 months prior to Visit 1 and be expected to remain stable for the duration of the trial.
    • If currently receiving dalfampridine or fampridine, it must be at a stable dose for at least 3 months prior to Visit 1 and is expected to remain stable for the duration of the trial.
    • Willing to allow the responsible authorities to be notified of participation in the trial, if mandated by local law.
    • Willing to allow his or her primary care practitioner (if he or she has one) and/or treating neurologist (if he or she has one) to be notified of participation in the trial, if the primary care practitioner/treating neurologist is different from the investigator.
    Additional Inclusion Criteria at Randomization (Visit 2)
    Patients are eligible for randomization in the trial if, in addition to continuing to meet the Screening (Visit 1) inclusion criteria, they also meet the following criterion prior to Visit 2 (Day 1):
    • Completed at least 5 of 7 days of their electronic diary reporting during the 7 days immediately preceding Visit 2 (Day 1).
    • Hombre o mujer, de 18 años en adelante.
    • Voluntad y capacidad de dar el consentimiento informado para participar en el ensayo.
    • Voluntad y capacidad (en opinión del investigador) de cumplir todos los requisitos del ensayo.
    • Diagnóstico de algún subtipo de EM, conforme a los criterios de McDonald revisados de 2017, desde un mínimo de 12 meses antes de la visita 1 y con expectativas de que permanezca estable durante todo el ensayo.
    • Puntuación MAS sin transformar igual o superior a 2, en 2 o más de los 6 grupos musculares (flexores de la rodilla derecha, flexores de la rodilla izquierda, extensores de la rodilla derecha, extensores de la rodilla izquierda, flexores plantares derechos y flexores plantares izquierdos) en la visita 1.
    • En caso de tratamiento en curso con un antiespástico autorizado, la pauta posológica debe haber permanecido estable durante un mínimo de 30 días antes de la visita 1. Voluntad de mantener el mismo medicamento antiespástico y no tener previsto iniciar un nuevo ciclo de fisioterapia durante todo el ensayo por parte del paciente.
    • En caso de tratamiento en curso con un fármaco aprobado modificador de la enfermedad para la EM, la dosis debe haber permanecido estable durante un mínimo de 3 meses antes de la visita 1 y debe estar previsto que permanezca estable durante todo el ensayo.
    • En caso de tratamiento en curso con dalfampridina o fampridina, la dosis debe haber permanecido estable durante un mínimo de 3 meses antes de la visita 1 y debe estar previsto que permanezca estable durante todo el ensayo.
    • Voluntad de permitir que se informe a las autoridades responsables de la participación en el ensayo, si así lo exige la legislación nacional.
    • Voluntad de permitir que se informe al médico de atención primaria (si corresponde) y/o al neurólogo responsable del tratamiento (si corresponde) de la participación en el ensayo, si alguno de estos médicos no es el investigador.
    Criterios de inclusión adicionales en la aleatorización (visita 2)
    Los pacientes son aptos para la aleatorización en el ensayo si, además de seguir cumpliendo los criterios de inclusión de la selección (visita 1), también cumplen el siguiente criterio antes de la visita 2 (día 1):
    • Haber rellenado al menos 5 de los 7 días del diario electrónico durante los 7 días inmediatamente anteriores a la visita 2 (día 1).
    E.4Principal exclusion criteria
    • Has taken nabiximols, cannabis, or a cannabis-derived product for medicinal or recreational purposes in the 30 days prior to Visit 1 or unable to abstain for the duration of the study.
    • Did not tolerate or did not respond adequately to treatment with nabiximols or another cannabis-based medication if exposed at any time before the 30-day period prior to Visit 1.
    • Any concomitant disease or disorder that has spasticity-like symptoms or that may influence the patient’s level of spasticity.
    • Medical history suggests that relapse/remission is likely to occur during the trial, which, in the opinion of the investigator, is expected to influence the patient’s spasticity.
    • Has had a relapse of MS within the 60 days prior to Visit 1.
    • Currently using botulinum toxin injection for the relief of spasticity (within 6 months of Visit 1) or is unwilling to abstain for the duration of the trial.
    • Currently taking antipsychotic medication.
    • Currently taking benzodiazepines unless doses and dosing regimen have been stable for at least 30 days prior to Visit 1.
    • Clinically suspected to have a contracture in one of the muscle groups of the lower limbs, preventing assessment with the MAS.
    • Has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP.
    • Has experienced myocardial infarction or clinically significant cardiac dysfunction within the 12 months prior to Visit 1 or has a cardiac disorder that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction.
    • Has a diastolic blood pressure of < 50 mmHg or > 105 mmHg or systolic blood pressure < 90 mmHg or > 150 mmHg (when measured in a sitting position at rest for 5 minutes) or a postural drop in the systolic blood pressure of > 20 mmHg at Visit 1 or Visit 2. All measurements will be performed singly and can be repeated once, if any are outside the reference range but not considered clinically significant.
    • Has clinically significant impaired renal function at Visit 1, as evidenced by an estimated creatinine clearance lower than 50 mL/min. All measurements will be performed singly and can be repeated once, if any are outside the reference range but not considered clinically significant.
    • Has moderately impaired hepatic function at Visit 1, defined as serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × upper limit of normal (ULN). All measurements will be performed singly and can be repeated once, if any are outside the reference range but not considered clinically significant.
    • Male and fertile (i.e., after puberty unless permanently sterile by bilateral orchiectomy) unless willing to ensure that he uses male contraception (condom or vasectomy) or remains sexually abstinent during the trial and for 3 months thereafter.
    • Female and of childbearing potential (i.e., following menarche and until becoming postmenopausal for ≥ 12 consecutive months unless permanently sterile by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) unless willing to ensure that she uses a highly effective method of birth control (e.g., intrauterine device/hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence) during the trial and for 3 months thereafter. Patients using combined hormonal methods or a progestogen-only pill or injection or implant should use an additional barrier method such as a male condom or diaphragm during the trial and for 3 months thereafter.
    • Female and pregnant (positive pregnancy test at Visit 1 or Visit 2), lactating, or planning pregnancy during the course of the trial or within 3 months thereafter.
    • Haber consumido nabiximols, cannabis o un derivado del cannabis con fines médicos o recreativos en los 30 días anteriores a la visita 1 o incapacidad de abstenerse de consumirlos durante el ensayo.
    • Intolerancia o respuesta inadecuada al tratamiento con nabiximols u otro medicamento a base de cannabis, en caso de exposición anterior al período de 30 días previos a la visita 1.
    • Cualquier enfermedad o trastorno concomitante que curse con síntomas seudoespásticos o que pueda influir en el nivel de espasticidad del paciente.
    • Antecedentes médicos indicativos de una recidiva/remisión probable durante el ensayo que, en opinión del investigador, se espera que vaya a influir en la espasticidad del paciente.
    • Recidiva de la EM en los 60 días previos a la visita 1.
    • Uso de inyecciones de toxina botulínica para el alivio de la espasticidad (en los 6 meses anteriores a la visita 1) o renuencia a abstenerse de utilizarlas durante el ensayo.
    • Tratamiento en curso con antipsicóticos.
    • Tratamiento en curso con benzodiazepinas, a menos que la dosis y la pauta posológica hayan sido estables durante un mínimo de 30 días antes de la visita 1.
    • Sospecha clínica de contractura en uno de los grupos musculares de las extremidades inferiores que impida la evaluación con la MAS.
    • Sospecha o certeza de hipersensibilidad a los cannabinoides o a cualquiera de los excipientes del MI.
    • Infarto de miocardio o disfunción cardíaca clínicamente significativa en los 12 meses anteriores a la visita 1, o trastorno cardíaco que, en opinión del investigador, ponga al paciente en riesgo de sufrir una arritmia de importancia clínica o un infarto de miocardio.
    • Tensión arterial diastólica <50 mm Hg o >105 mm Hg o tensión arterial sistólica <90 mm Hg o >150 mm Hg (tomada en sedestación tras un reposo de 5 minutos) o descenso ortostático de la tensión arterial sistólica >20 mm Hg en la visita 1 o la visita 2. Todas las mediciones se realizarán de manera individual y se pueden repetir una vez, si existen valores fuera del intervalo de referencia pero no se consideran clínicamente significativos.
    • Insuficiencia renal clínicamente significativa en la visita 1, demostrada por un aclaramiento de creatinina estimado inferior a 50 ml/min. Todas las mediciones se realizarán de manera individual y se pueden repetir una vez, si existen valores fuera del intervalo de referencia pero no se consideran clínicamente significativos.
    • Insuficiencia hepática moderada en la visita 1, definida por un valor sérico de alanina aminotransferasa (ALT) o de aspartato aminotransferasa (AST) >2 × límite superior de la normalidad (LSN). Todas las mediciones se realizarán de manera individual y se pueden repetir una vez, si existen valores fuera del intervalo de referencia pero no se consideran clínicamente significativos.
    • Hombres fértiles (es decir, pospuberales, a menos que sean estériles de forma permanente por orquiectomía bilateral), salvo que estén dispuestos a utilizar métodos anticonceptivos masculinos (preservativo o vasectomía) o mantengan la abstinencia sexual durante el ensayo y los 3 meses posteriores.
    • Mujeres con capacidad de concebir (es decir, posmenárquicas y hasta la posmenopausia durante un período ≥12 meses consecutivos, a menos que sean estériles de forma permanente por histerectomía, salpingectomía bilateral u ovariectomía bilateral) salvo que estén dispuestas a utilizar un método anticonceptivo muy eficaz (p. ej., dispositivo intrauterino/sistema de liberación de hormonas, oclusión tubárica bilateral, pareja vasectomizada o abstinencia sexual) durante el ensayo y los 3 meses posteriores. Las pacientes que utilicen métodos hormonales combinados o una píldora, inyección o implante de solo progesterona deben usar un método de barrera adicional, como un preservativo masculino o diafragma durante el ensayo y los 3 meses posteriores.
    • Mujer embarazada (resultado positivo en la prueba de embarazo de la visita 1 o la visita 2), en período de lactancia o que tiene previsto quedarse embarazada durante el ensayo o en los 3 meses posteriores.
    E.5 End points
    E.5.1Primary end point(s)
    Change in Lower Limb Muscle Tone-6 (LLMT-6; defined as the average of the 6 individual MAS transformed scores of knee flexors, knee extensors, and plantar flexors on both sides of the body) from Day 1 predose to Day 21 and from Day 31 predose to Day 51
    The MAS scores are transformed using the following algorithm: MAS untransformed [to MAS transformed] scores; 0[0], 1[1], 1+[2], 2[3], 3[4], and 4[5].
    Cambio en el Tono Muscular de las Extremidades Inferiores-6 (LLMT-6; definido como el promedio de las 6 puntuaciones individuales transformadas de la MAS de los flexores y extensores de la rodilla y los flexores plantares en ambos lados del cuerpo) desde el día 1 predosis hasta el día 21 y desde el día 31 predosis hasta el día 51.
    Las puntuaciones MAS se transforman con el siguiente algoritmo: Puntuaciones MAS no transformadas [a puntuaciones MAS transformadas]; 0[0], 1[1], 1+[2], 2[3], 3[4] y 4[5].
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Day 1 predose to Day 21 and from Day 31 predose to Day 51
    Desde el día 1 predosis hasta el día 21 y desde el día 31 predosis hasta el día 51.
    E.5.2Secondary end point(s)
    Efficacy:
    • Change in Lower Limb Muscle Tone-4 (LLMT-4; defined as the average of the 4 individual MAS transformed scores of knee flexors and knee extensors on both sides of the body) from Day 1 predose to Day 21 and from Day 31 predose to Day 51
    Safety:
    • Frequency of treatment-emergent adverse events (TEAEs)
    • Change from baseline to each assessment time point by treatment period for the following:
    • Clinical laboratory parameters
    • Vital signs
    • Physical examination procedures
    • 12-lead electrocardiograms (ECGs)
    • Columbia-Suicide Severity Rating Scale (C-SSRS) at screening, and at each subsequent time point with reference to the last assessment (since last visit)
    Pharmacokinetics:
    • Plasma concentrations for Δ9-tetrahydrocannabinol (THC) and its relevant metabolites (11-hydroxy-Δ9-tetrahydrocannabinol and 11-carboxy-Δ9-tetrahydrocannabinol) and cannabidiol (CBD) and its relevant metabolites (7-hydroxy-cannabidiol and 7-carboxy-cannabidiol) at distinct time points during each treatment period (Visits 2, 4, 5, 6, 8, and 9)
    Eficacia:
    • Cambio en el Tono Muscular de las Extremidades Inferiores-4 (LLMT-4; definido como el promedio de las 4 puntuaciones individuales transformadas de la MAS de los flexores y extensores de la rodilla en ambos lados del cuerpo) desde el día 1 predosis hasta el día 21 y desde el día 31 predosis hasta el día 51.
    Seguridad:
    • Frecuencia de acontecimientos adversos surgidos durante el tratamiento (AAST).
    • Cambio desde el inicio hasta cada punto temporal de evaluación por período de tratamiento en lo siguiente:
    • Parámetros de los análisis clínicos
    • Constantes vitales
    • Hallazgos de la exploración física
    • Electrocardiogramas (ECG) de 12 derivaciones
    • Escala Columbia para evaluar el riesgo de suicidio (Columbia-Suicide Severity Rating Scale, C-SSRS) en la selección y en cada punto temporal posterior en relación con la última evaluación (desde la última visita).
    Farmacocinética:
    • Concentraciones plasmáticas de Δ9 tetrahidrocannabinol (THC) y sus metabolitos pertinentes (11 hidroxi-Δ9 tetrahidrocannabinol y 11-carboxi-Δ9 tetrahidrocannabinol) y de cannabidiol (CBD) y sus metabolitos pertinentes (7 hidroxi-cannabidiol y 7-carboxi-cannabidiol) en distintos puntos temporales de cada período de tratamiento (visitas 2, 4, 5, 6, 8 y 9).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: from Day 1 predose to Day 21 and from Day 31 predose to Day 51

    Safety: Change from baseline to each assessment time point by treatment period; Columbia-Suicide Severity Rating Scale (C-SSRS) at screening, and at each subsequent time point with reference to the last assessment (since last visit)

    Pharmacokinetics: at distinct time points during each treatment period (Visits 2, 4, 5, 6, 8, and 9)
    Eficacia: Desde el día 1 predosis hasta el día 21 y desde el día 31 predosis hasta el día 51.

    Seguridad: Cambio desde el inicio hasta cada punto temporal de evaluación por período de tratamiento; Escala Columbia para evaluar el riesgo de suicidio (Columbia-Suicide Severity Rating Scale, C-SSRS) en la selección, y en cada punto temporal posterior en relación con la última evaluación (desde la última visita).

    Farmacocinética: En distintos puntos temporales de cada período de tratamiento (visitas 2, 4, 5, 6, 8 y 9).
    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 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) 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 Yes
    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 concerned5
    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 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
    Belgium
    Poland
    Spain
    Sweden
    United Kingdom
    Czechia
    E.8.7Trial has a data monitoring committee No
    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
    UVUP
    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 months0
    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 months2
    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: 169
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 177
    F.4.2.2In the whole clinical trial 190
    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)
    There will be no post-trial provision of Nabiximols.
    No habrá suministro de nabiximols después de finalizar el ensayo
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-11-11
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