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    Summary
    EudraCT Number:2020-003698-24
    Sponsor's Protocol Code Number:40411813EPY2001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-02-08
    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 number2020-003698-24
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-40411813 as Adjunctive Therapy in Subjects with Focal Onset Seizures with Suboptimal Response to Levetiracetam
    Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y multicéntrico para evaluar la eficacia, la seguridad y la tolerabilidad de JNJ-40411813 como tratamiento complementario en sujetos con crisis epilépticas de inicio focal con respuesta subóptima a levetiracetam.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate JNJ-40411813 in combination with levetiracetam in epilepsy
    Estudio para investigar JNJ-40411813 en combinación con levetiracetam en la epilepsia
    A.3.2Name or abbreviated title of the trial where available
    A study to investigate JNJ-40411813 in combination with levetiracetam in epilepsy
    Estudio para investigar JNJ-40411813 en combinación con levetiracetam en la epilepsia
    A.4.1Sponsor's protocol code number40411813EPY2001
    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 SponsorJanssen-Cilag International NV
    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 supportJanssen Research and Development LLC, US
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag S.A.
    B.5.2Functional name of contact pointGlobal Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number34661 310112
    B.5.5Fax number34917228628
    B.5.6E-mailpblanco3@its.jnj.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 nameJNJ-40411813
    D.3.2Product code JNJ-40411813
    D.3.4Pharmaceutical form Tablet
    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 INNNOT APPLICABLE
    D.3.9.1CAS number 1127498-036
    D.3.9.2Current sponsor codeJNJ-40411813
    D.3.9.3Other descriptive nameJNJ-40411813-AAA
    D.3.9.4EV Substance CodeSUB30639
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 nameJNJ-40411813
    D.3.2Product code JNJ-40411813
    D.3.4Pharmaceutical form Tablet
    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 INNNOT APPLICABLE
    D.3.9.1CAS number 1127498-036
    D.3.9.2Current sponsor codeJNJ-40411813
    D.3.9.3Other descriptive nameJNJ-40411813-AAA
    D.3.9.4EV Substance CodeSUB30639
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 placeboTablet
    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
    Focal Onset Seizures
    Crisis epilépticas de inicio focal
    E.1.1.1Medical condition in easily understood language
    Seizures
    Crisis epilépticas
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10015037
    E.1.2Term Epilepsy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065337
    E.1.2Term Focal epilepsy
    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
    The primary objective of this study is to evaluate the efficacy of adjunctive JNJ 40411813 compared to placebo in participants with focal onset seizures who are receiving levetiracetam and up to 3 other anti-epileptic drugs (AEDs)
    El objetivo principal de este estudio es evaluar la eficacia de hasta 3 niveles de dosis de JNJ-40411813 como tratamiento complementario en comparación con placebo en función del tiempo hasta el recuento de crisis mensuales en el momento de referencia en participantes con crisis de inicio focal que reciben levetiracetam y hasta otros 3 fármacos antiepilépticos (FAEs).
    E.2.2Secondary objectives of the trial
    -To evaluate the overall safety and tolerability of adjunctive JNJ-40411813 compared to placebo in participants with focal onset seizures who are receiving levetiracetam and up to 3 other AEDs.
    -To evaluate the efficacy of adjunctive JNJ-40411813 compared to placebo in participants with focal onset seizures.
    -To evaluate the pharmacokinetics (PK) of JNJ-40411813
    - Evaluar la seguridad y la tolerabilidad generales de JNJ-40411813 como tratamiento complementario en comparación con placebo en participantes con crisis de inicio focal que reciben levetiracetam y hasta otros 3 FAEs.
    - Evaluar la eficacia de hasta 3 niveles de dosis de JNJ-40411813 como tratamiento complementario en comparación con placebo en función del porcentaje de reducción del recuento de crisis mensuales en doble ciego, en relación con el recuento de crisis mensuales previo a la aleatorización, en participantes con crisis de inicio focal.
    - Evaluar la eficacia de JNJ-40411813 durante el periodo doble ciego utilizando el porcentaje de participantes con ausencia de crisis y el porcentaje de participantes con respuesta (>50 % de reducción de la tasa de crisis).
    - Evaluar la farmacocinética (FC) de JNJ-40411813 y los metabolitos seleccionados y levetiracetam en participantes con crisis de inicio focal que reciben levetiracetam y hasta otros 3 FAEs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants must be men or women, 18 to 69 years of age, inclusive.
    2. Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive (BMI=weight/height2). Minimum body weight should be 40 kg.
    3. Established diagnosis of focal epilepsy, for at least 1 year using the International League Against Epilepsy (ILAE) criteria (Fisher 2017).
    4. Must have had a neuroimaging procedure within 10 years, including a computed tomography (CT) scan or magnetic resonance imaging (MRI), that excluded a progressive neurologic disorder.
    5. Current treatment with at least 1 and up to 4 AEDs (including levetiracetam), administered at stable dosage(s) for at least 1 month before screening, and no new AEDs added for the previous 2 months; these AEDs must remain unchanged throughout the pretreatment.
    1. Los participantes deben ser varones o mujeres, de entre 18 y 69 años, inclusive.
    Nota: Los participantes deben tener por lo menos 18 años según la edad legal de consentimiento en la jurisdicción en la que se realice el estudio.
    2. Índice de masa corporal (IMC) entre 18 y 35 kg/m2 inclusive (IMC = peso/estatura2). El peso corporal mínimo deberá ser de 40 kg.
    3. Criterio modificado según la enmienda INT-1
    3.1 Diagnóstico confirmado de epilepsia focal durante al menos 1 año utilizando los criterios de la Liga Internacional contra la Epilepsia (ILAE) (Fisher 2017). Los participantes no deberán reclutarse si se sabe que han tenido menos de 3 o más de 100 crisis en cualquier periodo mensual en los últimos 6 meses. Es preferible que los participantes tengan experiencia en llevar un diario electrónico de las crisis.
    4. Criterio modificado según la enmienda INT-1
    4.1 Deben haberse sometido a un procedimiento de neuroimagen en los últimos 10 años, incluida una tomografía computarizada (TAC) o una resonancia magnética (RM), que excluyera un trastorno neurológico progresivo; estos procedimientos pueden realizarse en el periodo de referencia de 8 semanas.
    5. Tratamiento actual con al menos 1 y hasta 4 FAEs (incluido levetiracetam), administrados en dosis estables durante al menos 1 mes antes de la selección y sin haber añadido ningún FAE nuevo durante los 2 meses anteriores; estos FAEs deben permanecer sin cambios durante los periodos de pretratamiento y de tratamiento doble ciego (a excepción de las reducciones de dosis de los FAEs concomitantes debido a la sospecha de niveles elevados de FAEs o efectos secundarios).
    E.4Principal exclusion criteria
    1. Have a generalized epileptic syndrome.
    2. Diagnosis of Lennox-Gastaut Syndrome.
    3. Currently experiencing seizures that cannot be counted accurately.
    4. History of any current or past nonepileptic seizures, including psychogenic seizures.
    5. Current treatment with vagus nerve stimulation, deep brain and cortical stimulation for 1 year or less.
    1. Tener un síndrome epiléptico generalizado.
    2. Tener un diagnóstico del síndrome de Lennox-Gastaut.
    3. Experimentar actualmente crisis que no puedan contabilizarse con exactitud, por ejemplo, por los siguientes motivos:
    • Frecuencia extrema o en racimo.

    • Ausencia de un inicio y cese claros entre las crisis.
    • Falta de un informador que proporcione un recuento de las crisis cuando el participante sea incapaz de recordarlas de forma independiente.
    4. Antecedentes de crisis no epilépticas actuales o anteriores, incluidas crisis psicógenas.
    5. Tratamiento actual con estimulación del nervio vago, estimulación cerebral profunda y estimulación cortical durante 1 año o menos.
    6. Cirugía de epilepsia programada en los siguentes 6 meses o cirugía de epilepsia realizada hace <6 meses.
    7. Tratamiento actual con vigabatrina. En el caso de antecedentes de uso previo de vigabatrina, debe haberse realizado un examen del campo visual en el pasado después de la discontinuación de vigabatrina. Este examen debe haber sido fiable y haberlo realizado un oftalmólogo o neurooftalmólogo. El examen del campo visual no tiene por qué ser normal, pero debe ser estable.
    E.5 End points
    E.5.1Primary end point(s)
    Time to baseline monthly seizure count.
    Tiempo hasta el recuento de crisis mensuales en el momento de referencia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, up to 12 weeks
    Periodo de referencia, hasta 12 semanas
    E.5.2Secondary end point(s)
    1-Adverse events, significant changes in vital signs, ECG and safety laboratory results.
    2-Percent reduction in the double-blind monthly seizure count.
    3-Percent participants with seizure freedom and percent responders (>50% seizure rate reduction).
    4-Plasma concentrations of JNJ-40411813.
    1-Eventos adversos, cambios significativos en los signos vitales, ECG y resultados de laboratorio de seguridad.
    2-Porcentaje de reducción del recuento de crisis mensuales en doble ciego
    3-Porcentaje de participantes con ausencia de crisis y el porcentaje de participantes con respuesta (>50 % de reducción de la tasa de crisis).
    4-Concentraciones plasmáticas de JNJ-40411813.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-Full study period.
    2-Baseline, up to 12 weeks.
    4-Various timepoints over treatment period.
    1-Periodo de estudio completo.
    2-Periodo de referencia, hasta 12 semanas.
    4-Varios momentos durante el período de tratamiento.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Torelabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Germany
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    Ukraine
    United States
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 112
    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)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-03
    P. End of Trial
    P.End of Trial StatusOngoing
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