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    Summary
    EudraCT Number:2021-001433-39
    Sponsor's Protocol Code Number:NBI-921352-FOS2021
    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:2021-09-23
    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 number2021-001433-39
    A.3Full title of the trial
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of NBI-921352 as Adjunctive Therapy in Adult Subjects with Focal Onset Seizures (FOS)
    Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis para investigar la seguridad, tolerabilidad, farmacocinética y eficacia de NBI-921352 como tratamiento adyuvante en participantes adultos con crisis epilépticas focales (CEF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate how effective, safe and tolerable the drug NBI-921352 is when used with anti-seizure medications in adults with focal onset seizures
    Estudio para investigar como de efectivo, seguro y tolerable es el medicamento NBI-921352 cuando se usa con medicamentos anticonvulsivosen en adultos con crisis epilépticas focales (CEF)
    A.4.1Sponsor's protocol code numberNBI-921352-FOS2021
    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 SponsorNeurocrine Biosciences, Inc.
    B.1.3.4CountryUnited States
    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 supportNeurocrine Biosciences Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeurocrine Biosciences Inc.
    B.5.2Functional name of contact pointMedical Information Call Center
    B.5.3 Address:
    B.5.3.1Street Address12780 El Camino Real
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18586177600
    B.5.6E-mailmedinfo@neurocrine.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.3.2Product code NBI-921352
    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 INNNBI-921352
    D.3.9.1CAS number 2154406-04-7
    D.3.9.2Current sponsor codeNBI-921352
    D.3.9.3Other descriptive nameNBI-921352
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNBI-921352
    D.3.9.1CAS number 2154406-04-7
    D.3.9.2Current sponsor codeNBI-921352
    D.3.9.3Other descriptive nameNBI-921352
    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 (FOS)
    Crisis epilépticas focales (CEF)
    E.1.1.1Medical condition in easily understood language
    Epilepsy
    Epilepsia
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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
    The study is designed to facilitate the selection of a suitable dose range of NBI-921352 for use in subsequent efficacy and safety studies in adult subjects with FOS. The study objectives are as follows:
    • To assess the safety and tolerability of NBI-921352 in adults with FOS taking concomitant background ASMs.
    • To characterize the PK and PK/pharmacodynamic (PD) relationship of NBI-921352 and determine the effect of NBI-921352 on plasma levels of background ASMs.
    • To assess the efficacy of NBI-921352 on FOS frequency and quality of life in adults with FOS taking concomitant background ASMs.
    El estudio está diseñado para facilitar la selección de un rango de dosis adecuado de NBI-921352 que se usará en posteriores estudios de eficacia y seguridad en participantes adultos con CEF. Los objetivos del estudio son los siguientes:
    • Evaluar la seguridad y la tolerabilidad de NBI-921352 en adultos con CEF que toman medicamentos anticonvulsivos de base concomitantes (MAC).
    • Determinar la relación farmacocinética (FC) y farmacodinámica (FD) de NBI-921352 y el efecto de NBI-921352 en los niveles plasmáticos de los MAC de base.
    • Evaluar la eficacia de NBI-921352 sobre la frecuencia de las CEF y la calidad de vida en adultos con CEF que toman MAC de base concomitantes.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria:
    1. Capable of providing consent and has completed the written informed consent.
    2. Male or female, 18 to 65 years of age, inclusive, with a body mass index <40 kg/m2.
    3. Diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017) at least 18 months before screening. Diagnosis must be confirmed using the central adjudication process.
    4. Documented seizure frequency in the baseline seizure diary
    5. History of uncontrolled seizures despite adequate treatment with at least 1 anti-seizure (ASM) for at least 18 months prior to screening.
    6. Treatment with at least 1 but not more than 4 ASMs for at least 18 month before screening.
    7. Female subjects of childbearing potential must agree to use contraception consistently from screening until the final study visit or 30 days after the last dose of study treatment, whichever is longer.
    8. Be able to keep accurate seizure diaries.
    Los sujetos deben cumplir todos los criterios de inclusión siguientes:
    1. Ser capaz de otorgar su consentimiento y haber rellenado el consentimiento informado por escrito.
    2. Hombre o mujer de 18 a 65 años, ambos incluidos, con un índice de masa corporal <40 kg/m2.
    3. Diagnóstico de epilepsia de inicio focal de acuerdo con la clasificación de la epilepsia (2017) de la Liga Internacional contra la Epilepsia (ILAE) al menos 18 meses antes de la selección.
    4. Frecuencia documentada de las crisis en el diario de crisis
    5. Antecedentes de crisis no controladas a pesar de recibir un tratamiento adecuado con al menos 1 FAE (fármaco antiepiléptico) durante al menos 18 meses antes de la selección.
    6. Tratamiento con al menos 1 FAE, pero no más de 4 durante al menos 1 mes antes de la selección, durante la recogida de datos del diario de crisis inicial y a lo largo del estudio.
    7. Los sujetos del sexo femenino con capacidad de procrear deben aceptar el uso de sistemático de métodos anticonceptivos desde la selección hasta la visita de final del estudio o hasta 30 días después de la última dosis del tratamiento del estudio, lo que sea más largo.
    8. Ser capaz de llevar un diario exacto de las convulsiones.
    E.4Principal exclusion criteria
    Subjects will be excluded from the study if they meet any of the following criteria:
    -. History of epilepsy with only nonmotor seizures without an observable component, psychogenic nonepileptic seizures, or primary generalized seizures.
    -. Presence or previous history of developmental and/or epileptic encephalopathy.
    -. Presence of seizure types other than FOS.
    -. History of repetitive seizures within the 12-month period preceding study entry where the individual seizures cannot be counted.
    -. Status epilepticus within the last 12 months before enrollment.
    -. Any suicidal behavior or suicidal ideation of type 4 or type 5 in the 2 years before screening, a history of suicide
    attempt in the last 2 years, or more than 1 lifetime suicide attempt.
    -. History or presence of any significant medical or surgical condition, lab value, or concomitant medication that would place the subject at increased risk as determined by the investigator
    -. A known history of clinically concerning cardiac arrhythmia (including long QT syndrome) or prolongation of screening (pre-treatment) QT interval corrected for heart rate.
    -. Currently taking disallowed medications listed in Section 7.1.1 or it is anticipated that the subject will require treatment with at least 1 of the disallowed concomitant medications during the study.
    -. Past use of vigabatrin without stable visual fields tested twice in the 12 months after the last dose of vigabatrin.
    -. Require use of rescue medication more than once per week
    -. Multiple drug allergies or a severe drug reaction to an ASM(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
    -. An implanted responsive neurostimulator system (RNS).
    Se excluirá del estudio a los sujetos que cumplan cualquiera de los siguientes criterios:
    -. Antecedentes de epilepsia con solo crisis no motoras sin un componente observado, crisis psicógenas no epilépticas o crisis generalizadas primarias.
    -. Presencia o antecedentes de encefalopatía del desarrollo o epiléptica.
    -. Presencia de tipos de crisis diferentes a la crisis de inicio focal.
    -. Antecedentes de crisis reiteradas en el periodo de 12 meses anterior a la entrada en el estudio en las que no se puedan contabilizar crisis individuales.
    -. Estado epiléptico en los últimos 12 meses antes de la inscripción.
    -. Cualquier comportamiento suicida o ideación suicida de tipo 4 o de tipo 5 en los últimos 2 años o más de 1 intento de suicidio durante su vida.
    -. Antecedentes o presencia de cualquier afección médica o quirúrgica significativa, valores analíticos, medicaciones concomitantes u otras afecciones que pondrían al sujeto en un riesgo mayor según el criterio del investigador.
    -. Antecedentes conocidos de arritmia cardíaca de relevancia clínica (incluido síndrome de QT largo) o prolongación del intervalo QT de la selección (pretratamiento) corregido para la frecuencia cardíaca
    -. Uso actual de los medicamentos no permitidos enumerados en la sección 7.1.1 o previsión de que el sujeto requerirá tratamiento con al menos 1 de los medicamentos concomitantes prohibidos durante el estudio.
    -. Uso previo de vigabatrina sin campos visuales estables evaluados dos veces durante los 12 meses posteriores a la última dosis de vigabatrina
    -. Necesidad de usar medicación de rescate más de una vez a la semana.
    -. Alergias a múltiples fármacos o una reacción farmacológica grave a un FAE, incluidas reacciones dermatológicas (p. ej., síndrome de Stevens-Johnson), hematológicas o de toxicidad orgánica.
    -. Tener un sistema de neuroestimulador con capacidad de respuesta implantado
    E.5 End points
    E.5.1Primary end point(s)
    Primary:
    • Number of participants with serious Serious Treatment-emergent Adverse Events (TEAEs), TEAEs leading to discontinuation of study treatment, and fatal TEAEs
    • NBI-921352 PK/PD, including exposure-efficacy response relationship
    Principales:
    • Numero de participantes con Eventos Adversos graves emergentes del tratamiento (AAST graves), AAST que provocan la interrupción del tratamiento del estudio y AAST mortales
    • FC y FD de NBI-921352, incluida la relación entre la exposición y la eficacia de la respuesta
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Treatment Period: Day 1 to Week 11
    El periodo de referencia, el periodo de tratamiento: Dia 1 Semana 11
    E.5.2Secondary end point(s)
    Secondary:
    • Percent change from baseline in monthly FOS frequency during the treatment
    • Percent change from baseline in monthly FOS frequency during the maintenance period
    • Clinical Global Impression of Change (CGIC) scores at Week 11
    • Treatment response defined as ≥50% reduction in monthly (28 days) FOS frequency during the treatment period compared to the seizure baseline period
    Secundarios:
    • Cambio porcentual desde el periodo de referencia en la frecuencia mensual de CEF durante el período de tratamiento.
    • Cambio porcentual desde el periodo de referencia en la frecuencia mensual de CEF durante el período de mantenimiento
    • Puntuaciones de la Impresión Clínica Global del Cambio en la semana 11
    • Se define la respuesta al tratamiento como una reducción de >50 % en la frecuencia mensual (28 días) de las CEF durante el período de tratamiento en comparación con el período de referencia de las crisis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, Treatment Period: Day 1 to Week 11; Maintenance Period:
    Week 4 to Week 11
    El periodo de referencia, el periodo de tratamiento: dia 1 semana 11, y el periodo de mantenimiento: de semana 4 a semana 11 de ocho semanas.
    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 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 trial4
    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 EEA26
    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
    France
    Hungary
    Italy
    Spain
    United Kingdom
    Czechia
    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 úlimo paciente
    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 months3
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days15
    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: 92
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 100
    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 treatment as discussed with their doctor or eligible subjects will have the option to enrol into an extension study to receive NBI-921352.
    El tratamiento normal según lo acordado con su médico o los sujetos elegibles tendrán la opción de partticipar en un estudio de extensión para recibir NBI-921352.
    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 Decision2021-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-29
    P. End of Trial
    P.End of Trial StatusOngoing
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