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    Summary
    EudraCT Number:2020-002750-24
    Sponsor's Protocol Code Number:N01269
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-02-06
    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 number2020-002750-24
    A.3Full title of the trial
    A Randomized, Dose-Finding and Confirmatory, Double-Blind, Placebo-Controlled, Parallel-Group Multicenter Study With a 2-Stage Adaptive Design and Randomized Withdrawal to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
    Estudio aleatorizado, de búsqueda de dosis y de confirmación, doble ciego, controlado con placebo, de grupos paralelos y multicéntrico con un diseño adaptativo de 2 etapas y retirada aleatorizada para evaluar la eficacia, la seguridad y la tolerabilidad de brivaracetam como monoterapia en pacientes de 2 a 25 años de edad con epilepsia de ausencia infantil o epilepsia de ausencia juvenil.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy, safety, and tolerability of brivaracetam as monotherapy in patients 2 to 25 years of age with childhood absence epilepsy or juvenile absence epilepsy
    Estudio de la eficacia, la seguridad y la tolerabilidad de BRV como monoterapia en los participantes del estudio de 2 a 25 años de edad con epilepsia de ausencia infantil o epilepsia de ausencia juvenil.
    A.4.1Sponsor's protocol code numberN01269
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/173/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUCB Biopharma SRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number+34638210511
    B.5.6E-mailclinicaltrials@ucb.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 Briviact
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    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.3.4Pharmaceutical 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 INNBRIVARACETAM
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeBRV
    D.3.9.3Other descriptive nameucb 34714
    D.3.9.4EV Substance CodeSUB25397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    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 nameBrivaracetam
    D.3.2Product code BRV
    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 INNBRIVARACETAM
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeBRV
    D.3.9.3Other descriptive nameucb 34714
    D.3.9.4EV Substance CodeSUB25397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    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 nameBrivaracetam
    D.3.2Product code BRV
    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 INNBRIVARACETAM
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeBRV
    D.3.9.3Other descriptive nameucb 34714
    D.3.9.4EV Substance CodeSUB25397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    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
    Childhood absence epilepsy and juvenile absence epilepsy
    Epilepsia de ausencia infantil o epilepsia de ausencia juvenil.
    E.1.1.1Medical condition in easily understood language
    Absence seizures are a type of seizure that involves brief, sudden lapses in attention. Symptoms include staring into space for a few seconds, lip smacking, eyelid fluttering, and chewing motions.
    Las crisis de ausencia implican lapsus de atención breves y repentinos. Los síntomas son mirar al espacio fijamente durante unos segundos, fruncir labios, parpadear y hacer movimientos de masticación
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigate the efficacy of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive, with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)
    Investigar la eficacia de brivaracetam en monoterapia en los participantes del estudio de 2 a 25 años de edad, ambos inclusive, con epilepsia de ausencia infantil (EAI) o epilepsia de ausencia juvenil (EAJ).
    E.2.2Secondary objectives of the trial
    Evaluate the safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive, with CAE or JAE
    Evaluar la seguridad y la tolerabilidad de brivaracetam en monoterapia en los participantes del estudio de 2 a 25 años de edad, ambos inclusive, con EAI o EAJ.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Study participant is 2 to 25 years of age inclusive, at the time of signing the informed consent. No study participants from 2 to <4 years of age will be included in Stage 1.
    -Study participant is diagnosed with either childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE) as defined by the International League Against Epilepsy (ILAE) criteria
    -Study participants 2 to <4 years of age and participants who had onset of absence seizures at an age younger than 4 years must have a negative glucose transporter type 1 deficiency syndrome (GLUT1DS) genetic test
    -Study participant is untreated with antiepileptic drugs (AEDs) or pretreated for absence seizures with a maximum of 2 historical AEDs, but without AED treatment for a period of at least 5 half-lives of the AED before randomization into this study. The UCB study physician should be consulted if in doubt
    -Study participant has electroencephalogram (EEG) evidence of bilateral synchronous, symmetric generalized paroxysmal spike waves (2.5-6 hertz) with normal background activity and with at least 1 electrographically recorded seizure lasting 3 seconds or more on a 1-hour EEG with hyperventilation (HV) while awake at Visit 1 (V1), or on an historical EEG up to 12 weeks before enrollment
    -Study participant has a history of clinically evident absence seizures occurring on at least 3 days per week in the 2 weeks prior to enrollment
    -Study participant is without treatment with psychoactive drugs or on a stable dose for at least 2 weeks prior to randomization
    -Study participant has normal neurological examination, head size, development and cognition
    -Body weight is ≥9 kg
    -Male and female
    a) A sexually active male study participant must agree to use contraception during the treatment period and for at least 2 days, corresponding to the time needed to eliminate study treatment, after the last dose of study treatment and refrain from donating sperm during this period
    b) A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
    The study participant is premenarchial
    OR
    A woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the last dose of study treatment, corresponding to the time needed to eliminate study treatment
    - Study participant is capable of and provides consent/assent, and the study participant’s parent/legal representative/caregiver provides signed informed consent for minor study participants, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
    El participante del estudio tiene de 2 a 25 años de edad, ambos inclusive, en el momento de firmar el formulario de consentimiento informado. En la etapa 1, no se incluirá a ningún participante del estudio que tenga de 2 a <4 años de edad.
    -Al participante del estudio se le ha diagnosticado epilepsia de ausencia infantil (EAI) o epilepsia de ausencia juvenil (EAJ), como se define en los criterios de la Liga Internacional contra la Epilepsia (International League Against Epilepsy, ILAE).
    -Los participantes del estudio que tengan de 2 a <4 años de edad y los participantes que sufrieron crisis de ausencia cuando tenían menos de 4 años deben tener una prueba genética del síndrome por deficiencia del transportador de glucosa tipo 1 (GLUT1DS) negativa.
    -El participante del estudio no recibe tratamiento con antiepilépticos (antiepileptic drugs, AED) o ha recibido un tratamiento con anterioridad para las crisis de ausencia con un máximo de 2 AED, pero sin tratamiento con AED durante un periodo de al menos 5 semividas del AED antes de la aleatorización a este estudio. En caso de duda, se debe consultar al médico del estudio de UCB.
    -El participante del estudio tiene indicios en el electroencefalograma (EEG) de ondas agudas (2,5-6 hercios), paroxísticas, generalizadas, simétricas, sincrónicas y bilaterales con una actividad de fondo normal y con al menos 1 crisis registrada electrográficamente con una duración de 3 segundos o más en un EEG de 1 hora con hiperventilación (HV) mientras está despierto en la visita 1 (V1) o en un EEG histórico de hasta 12 semanas antes de la inscripción.
    -El participante del estudio tiene antecedentes de crisis de ausencia clínicamente evidentes producidas al menos 3 días a la semana en las 2 semanas previas a la inscripción.
    -El participante del estudio no ha recibido tratamiento con psicofármacos o ha recibido una dosis estable durante al menos 2 semanas antes de la aleatorización.
    -El participante del estudio tiene una exploración neurológica, un tamaño de la cabeza, un desarrollo y una cognición normales.
    -El peso corporal es ≥9 kg.
    -Hombre y mujer.
    a) Un participante del estudio de sexo masculino sexualmente activo debe aceptar el uso de anticonceptivos durante el periodo de tratamiento y durante al menos 2 días, lo que corresponde al tiempo necesario para eliminar el tratamiento del estudio, después de la última dosis del tratamiento del estudio y abstenerse de donar esperma durante este periodo.
    b) Una participante del estudio de sexo femenino es apta para participar si no está embarazada ni en periodo de lactancia y si cumple, al menos, 1 de los siguientes requisitos:
    La participante del estudio es premenárquica
    O BIEN
    Una mujer en edad fértil (MEF) que acepta seguir las directrices sobre anticoncepción durante el periodo de tratamiento y durante al menos 2 días después de la última dosis del tratamiento del estudio, lo que corresponde al tiempo necesario para eliminar el tratamiento del estudio.
    -El participante del estudio puede proporcionar y proporciona su consentimiento/asentimiento y el progenitor/representante legal/cuidador del participante del estudio proporciona su consentimiento informado firmado para los participantes menores del estudio, que incluye el cumplimiento de los requisitos y las restricciones mencionadas en el formulario de consentimiento informado (FCI) y en este protocolo.
    E.4Principal exclusion criteria
    -Study participant has a history of nonfebrile seizures other than absence seizures (eg, generalized tonic-clonic seizures or myoclonic seizures)
    -Study participant has a history of absence status epilepticus
    -Study participant has a history or presence of paroxysmal nonepileptic seizures
    -Study participant has a clinically relevant electrocardiogram (ECG) abnormality in the opinion of the Principal Investigator
    -Study participant has hepatic impairment (Child Pugh Score A,B, C, or D) based on the Investigator’s assessment
    -Study participant has a history of major psychiatric disease or any clinically significant medical condition that would preclude appropriate study participation
    -Study participant has active suicidal ideation prior to study entry as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS; for study participants 6 years or older) or clinical judgement (for study participants younger than 6 years). The study participant should be referred immediately to a Mental Healthcare Professional
    -Study participant has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt). The study participant should be immediately evaluated by a Mental Healthcare Professional to address safety concerns
    - Study participant with known fructose intolerance or hypersensitivity of any of the ingredients in brivaracetam oral solution
    - Study participant has end-stage kidney disease requiring dialysis
    -Concomitant use of rifampicin/rifampin; prior use must have been stopped at least 2 months before randomization
    -Concomitant use of strong CYP2C19 inhibitors like fluconazole, fluoxetine and fluvoxamine, prior use must have been stopped at least 1 week before randomization
    -Study participant has participated in another study of an investigational medicinal product (IMP; and/or an investigational device) within the previous 30 days prior to informed consent
    -Study participant has clinical or EEG findings not consistent with a diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)
    --El participante del estudio tiene antecedentes de crisis no febriles aparte de crisis de ausencia (p. ej., crisis tonicoclónicas generalizadas o crisis mioclónicas).
    -El participante del estudio tiene antecedentes de estado epiléptico de ausencia.
    -El participante del estudio tiene antecedentes de crisis paroxísticas no epilépticas o las padece en la actualidad.
    -El participante del estudio presente una anomalía clínicamente relevante en el electrocardiograma (ECG) en opinión del investigador principal.
    -El participante del estudio tiene una insuficiencia hepática (Puntuación Child Pugh A,B, C, o D) según la evaluación del investigador.
    -El participante del estudio tiene antecedentes de enfermedad psiquiátrica grave o cualquier afección médica clínicamente significativa que impediría la participación adecuada en el estudio.
    -El participante del estudio tiene pensamientos suicidas activos antes de la entrada en el estudio, como lo indica una respuesta positiva (“Sí”) a la pregunta 4 o a la pregunta 5 de la Escala Columbia para Evaluar el Riesgo de Suicidio (Columbia-Suicide Severity Rating Scale, C-SSRS; para los participantes del estudio de 6 años o mayores) o el juicio clínico (para los participantes del estudio menores de 6 años). El participante del estudio debe ser derivado inmediatamente a un profesional de salud mental.
    -El participante del estudio tiene antecedentes permanentes de intento de suicidio (incluido un intento activo, intento interrumpido o intento frustrado). El participante del estudio debe ser evaluado inmediatamente por un profesional de salud mental para abordar los problemas de seguridad.
    - Participante del estudio con intolerancia conocida a la fructosa o hipersensibilidad a cualquiera de los ingredientes de la solución oral de brivaracetam
    - El participante del estudio tiene una enfermedad renal en etapa terminal que requiere diálisis
    -Uso concomitante de rifampicina/rifampina; el uso previo debe haberse suspendido al menos 2 meses antes de la aleatorización.
    -Uso concomitante de inhibidores potentes de CYP2C19 como fluconazol, fluoxetina y fluvoxamina; el uso previo debe haberse suspendido al menos 1 semana antes de la aleatorización.
    -El participante del estudio ha participado en otro estudio de un producto en investigación (PEI o un dispositivo en investigación) en los 30 días anteriores al consentimiento informado.
    -El participante del estudio tiene hallazgos clínicos o del EEG no congruentes con un diagnóstico de epilepsia de ausencia infantil (EAI) o epilepsia de ausencia juvenil (EAJ).
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of participants who met the criteria for absence seizure freedom within 4 days prior to or during the 24-hour ambulatory electroencephalogram (EEG) at Day 14
    Porcentaje de participantes que cumplieron los criterios de no presentar crisis de ausencia en los 4 días anteriores o durante el electroencefalograma (EEG) ambulatorio de 24 horas el día 14.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14
    Día 14
    E.5.2Secondary end point(s)
    1. Percentage of participants who met the criteria for absence seizure freedom during the randomized withdrawal (RDW) period as determined by electroencephalogram (EEG)
    2. Percent change from Baseline to Day 14 in number of absence seizures on 24-hour ambulatory electroencephalogram (EEG)
    3. Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Day 14
    4. Percentage of participants who met the criteria for absence seizure freedom on 24-hour ambulatory electroencephalogram (EEG) at Week 12
    5. Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Week 12
    6. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
    7. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment
    8. Percentage of participants with serious adverse events (SAEs) during the study
    9. Percentage of participants with drug-related treatment-emergent adverse events (TEAEs) during the study
    1. Porcentaje de participantes que cumplieron los criterios de no presentar crisis de ausencia durante el periodo de retirada aleatorizada (RA) determinado por el electroencefalograma (EEG).
    2. Porcentaje de cambio con respecto al inicio hasta el día 14 en el número de crisis de ausencia en el electroencefalograma (EEG) ambulatorio de 24 horas.
    3. Porcentaje de participantes que cumplieron los criterios de no presentar crisis de ausencia en función del diario durante los 4 días previos a la visita del día 14.
    4. Porcentaje de participantes que cumplieron los criterios de no presentar crisis de ausencia en el electroencefalograma (EEG) ambulatorio de 24 horas en la semana 12.
    5. Porcentaje de participantes que cumplieron los criterios de no presentar crisis de ausencia en función del diario durante los 4 días previos a la visita de la semana 12.
    6. Porcentaje de participantes con acontecimientos adversos surgidos durante el tratamiento (AAST) durante el estudio.
    7. Porcentaje de participantes con acontecimientos adversos surgidos durante el tratamiento (AAST) que provocaron la interrupción del tratamiento del estudio.
    8. Porcentaje de participantes con acontecimientos adversos graves (AAG) durante el estudio.
    9. Porcentaje de participantes con acontecimientos adversos surgidos durante el tratamiento (AAST) relacionados con el fármaco durante el estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From Week 13 to Week 17
    2. From Baseline to Day 14
    3. Day 14
    4.; 5. Week 12
    6.; 9.: From Day 1 until End of Safety Follow-Up (up to Week 23)
    7. From Day 1 until End of Down Titration Period (up to Week 21)
    8. From Screening Period (Day -14 to Day -2) until End of Safety Follow-Up (up to Week 23)
    1. Desde la semana 13 hasta la semana 17.
    2. Desde el inicio hasta el día 14.
    3. Día 14.
    4.; 5. Semana 12.
    6.; 9.: desde el día 1 hasta el final del seguimiento de la seguridad (hasta la semana 23).
    7. Desde el día 1 hasta el final del periodo de ajuste de la dosis a la baja (hasta la semana 21).
    8. Desde el periodo de selección (día -14 a día -2) hasta el final del seguimiento de la seguridad (hasta la semana 23).
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Ukraine
    Australia
    United States
    Belgium
    Germany
    Hungary
    Italy
    Poland
    Romania
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último paciente
    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 months11
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days25
    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: 128
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 64
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 64
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 32
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    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)
    Eligible subjects will be able to enroll in the follow up study EP0132.
    Los sujetos elegibles podrán inscribirse en el estudio de seguimiento EP0132.
    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 Decision2021-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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