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    Summary
    EudraCT Number:2020-003140-83
    Sponsor's Protocol Code Number:NBI-921352-DEE2012
    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:2021-11-19
    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 number2020-003140-83
    A.3Full title of the trial
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-921352 as Adjunctive Therapy in Subjects with SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)
    A.4.1Sponsor's protocol code numberNBI-921352-DEE2012
    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+34653249484
    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.3.1Product nameNBI-921352
    D.3.4Pharmaceutical form Granules
    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.3.9.2Current sponsor codeNBI-921352
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNBI-921352
    D.3.9.2Current sponsor codeNBI-921352
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNBI-921352
    D.3.9.2Current sponsor codeNBI-921352
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNBI-921352
    D.3.9.2Current sponsor codeNBI-921352
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNBI-921352
    D.3.9.2Current sponsor codeNBI-921352
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboGranules
    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
    SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)
    síndrome de encefalopatía epiléptica y del desarrollo asociada con SCN8A (SCN8A-DEE)
    E.1.1.1Medical condition in easily understood language
    Epilepsy
    Epilépsia
    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 10077380
    E.1.2Term Epileptic encephalopathy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the efficacy of NBI-921352 as adjunctive therapy on the frequency of countable motor seizures
    • Evaluar la eficacia de NBI-921352 como tratamiento complementario en la frecuencia de las crisis motoras contables
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of NBI-921352 using the Clinical and Parent/Caregiver Global Impression of Change scales and the Clinical and Parent/Caregiver Global Impression of Severity scales.
    • To characterize the pharmacokinetics of NBI-921352 and determine the effect of NBI-921352 on plasma levels of concomitant ASMs and evaluated metabolites.
    • To evaluate the safety and tolerability of NBI-921352.
    • Evaluar la eficacia de NBI-921352 utilizando las escalas de impresión clínica global del cambio de progenitores y cuidadores, y las escalas de impresión clínica global de la gravedad de progenitores y cuidadores.
    • Caracterizar la farmacocinética (FC) de NBI-921352 y determinar el efecto de NBI-921352 en la concentración plasmática de los medicamentos anticonvulsivos simultáneos (MAC) y los metabolitos evaluados.
    • Evaluar la seguridad y la tolerabilidad de NBI-921352.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Be a male or female 12 to 21 years of age, inclusive.
    • Have a diagnosis of SCN8A-DEE supported by both clinical and genetic findings
    • Have on average at least 1 countable motor seizure per week and not be seizure-free for more than 20 consecutive days.
    • Being treated with at least 1 other ASM, but no more than 4 ASMs.
    • Have failed to achieve seizure freedom with at least 2 ASMs.
    • Must be using a nocturnal alerting system or practice consistent with standards of care at the time of screening and continue to use this for the duration of the study.
    • Must have an adequate rescue medication regimen per the investigator’s judgment in place at the time of screening and for the duration of the study.
    • Have a body weight of at least 10 kg
    • The subject's parent/caregiver is able to accurately identify seizure types, especially countable motor seizures and is able to complete seizure diary
    * Ser hombre o mujer de 12 a 21 años, ambos inclusive.
    * Presentar un diagnóstico de SCN8A-DEE respaldado tanto por los hallazgos clínicos como genéticos
    * Presentar un diagnóstico de SCN8A-DEE confirmado por el DCP.
    * Tener en promedio al menos cuatro convulsiones motoras contables (definidas como convulsiones tónico-clónicas generalizadas, tónicas, atónicas o de inicio focal con componente motor notable) por mes durante los 90 días anteriores a la selección.
    * Tener un promedio de al menos una convulsión motora contable (definida como convulsión tónico-clónica generalizada, tónica, atónica o de inicio focal con un componente motor notable) por semana (cuatro por cada período de 28 días) y no haber pasado más de 20 días consecutivos sin convulsiones por cada período de 28 días dentro del período de inicio.
    * Contar con al menos cuatro semanas de datos diarios de convulsiones completados de forma fiable y consistente.
    * Recibir tratamiento con al menos otro medicamento anticonvulsivo, pero no más de cuatro. Epidiolex®/Epidyolex® se considerará medicamento anticonvulsivo. La dosis debe ser estable durante al menos cinco vidas medias al momento de la selección. El estimulador vagal y la dieta cetogénica no se cuentan como medicamentos anticonvulsivos.
    * No haber conseguido evitar las convulsiones con al menos dos medicamentos anticonvulsivos.
    * Si el sujeto utiliza un estimulador vagal, debe habérselo colocado al menos tres meses antes de la selección con ajustes estables de 2 a 30 días antes de la selección; los ajustes deben permanecer estables durante toda la duración del estudio.
    * Si el sujeto sigue una dieta cetogénica, debe haberla iniciado al menos 30 días antes de la selección; la dieta debe ser estable y continuar durante todo el estudio.
    * Debe estar utilizando un sistema o práctica de alerta nocturna acorde al estándar de atención médica al momento de la selección y continuar utilizándolo durante la duración del estudio.
    * Debe tener un régimen de medicación de rescate adecuado según el criterio del investigador al momento de la selección y durante la duración del estudio.
    * Las mujeres con posibilidad de quedar embarazadas deben aceptar utilizar métodos anticonceptivos de forma sistemática desde la selección hasta la última visita del estudio o 30 días después de la última dosis del tratamiento del estudio, lo que sea más largo
    * Pesar al menos 10 kg.
    * Poder llevar a cabo todas las evaluaciones apropiadas y tomar el tratamiento del estudio con la ayuda de los padres/cuidadores según el criterio del investigador.
    * El padre/cuidador del sujeto puede identificar con precisión los tipos de convulsiones, especialmente las convulsiones motoras contables (definidas como convulsiones tónico-clónicas generalizadas, tónicas, atónicas o de inicio focal con un componente motor notable) y puede completar el diario de convulsiones.
    E.4Principal exclusion criteria
    • Have previously been enrolled in this study and received blinded treatment.
    • Have participated in an interventional clinical trial <30 days prior to screening.
    • Have symptoms that would be more consistent with another epilepsy disorder such as Dravet syndrome (eg, fever-induced episodes of status epilepticus, frequent myoclonic seizures, worsening on sodium channel blockers, absence seizures with generalized spike-and-wave EEG as the sole seizure type).
    • Are currently receiving cannabinoids or medical marijuana except Epidiolex/Epidyolex, unless approved by the Sponsor.
    • Are currently taking systemic steroids (excluding inhaled medication for asthma treatments). If subject has received these medications in the past, must be off these medications for at least 3 months prior to the screening visit and these drugs may not be initiated during the duration of the study. Intermittent steroids to treat nonepilepsy related diseases (such as allergies or dermatological conditions) are not exclusionary.
    • Have a history of moderate or severe head trauma or other neurological disorders or systemic medical diseases that are, in the investigator’s opinion, likely to affect nervous system functioning.
    • Have a clinically significant medical condition or chronic disease that in the opinion of the investigator would preclude the subject from participating in and completing the study or that could confound interpretation of study outcome.
    • Have clinically significant abnormal vital signs at the screening visit as determined by the investigator.
    • Have one or more clinical laboratory test values outside the reference range, based on blood samples taken at the screening visit, that are of potential risk to the subject’s safety
    • Have, at the screening visit, an ECG finding of a corrected QT interval using Fridericia’s formula (QTcF) >450 msec or presence of any significant cardiac abnormality.
    * Haber participado previamente en este estudio y haber recibido un tratamiento enmascarado.
    * Haber participado en un ensayo clínico de intervención en los 30 días anteriores a la selección.
    * Tener síntomas que serían más consistentes con otro trastorno epiléptico como el síndrome de Dravet (por ejemplo, episodios de estado epiléptico inducidos por la fiebre, convulsiones mioclónicas frecuentes, empeoramiento con bloqueadores de los canales de sodio,crisis de ausencia con EEG generalizado de picos y ondas como
    único tipo de convulsión).
    * Estar recibiendo actualmente cannabinoides o marihuana medicinal, excepto Epidiolex/Epidyolex, a menos que el promotor lo apruebe.
    * Estar tomando actualmente esteroides sistémicos (excepto la medicación inhalada para los tratamientos del asma) como la hormona adrenocorticotrófica (ACTH), dosis elevadas de prednisolona para los espasmos epilépticos.
    * Estar tomando un inhibidor fuerte de CYP3A4 (por ejemplo, ketoconazol, eritromicina, ritonavir) o un inductor (por ejemplo, rifabutina, rifampicina, hierba de San Juan) que no sean medicamentos anticonvulsiones concurrentes.
    * Tener antecedentes de alergia al medicamento o hipersensibilidad grave al NBI-921352 o a sus excipientes.
    * Presentar una exposición previa a NBI-921352.
    * Tener cualquier otro trastorno cuyo tratamiento tenga prioridad sobre el tratamiento del SCN8A-DEE o que pueda interferir con el tratamiento del estudio o perjudicar el cumplimiento del mismo.
    * Tener antecedentes de traumatismo craneal moderado o grave u otros trastornos neurológicos o enfermedades médicas sistémicas que, según el criterio del investigador, puedan afectar al funcionamiento del sistema nervioso.
    * Tener una afección médica o enfermedad crónica clínicamente significativa (incluidos los antecedentes de enfermedades neurológicas, hepáticas, renales, cardiovasculares, gastrointestinales, de malabsorción significativa, hematológicas, pulmonares, psiquiátricas o endocrinas) que, según el criterio del investigador, impidan al sujeto participar y completar el estudio o que puedan confundir la interpretación de los resultados del estudio.
    * Estar tomando o haber recibido medicación concomitante no permitida (Sección 7.1) o que se prevea que el sujeto requerirá tratamiento con al menos uno de los medicamentos concomitantes no permitidos durante el estudio.
    * Presentar constantes vitales anómalas clínicamente significativas en la visita de selección, según lo determine el investigador.
    * Presentar uno o más valores de análisis de laboratorio clínicos fuera del rango de referencia, según las extracciones de sangre realizadas en la visita de selección, que supongan un riesgo potencial para la seguridad del sujeto.
    * Presentar en la visita de selección un ECG con un intervalo QT corregido mediante la fórmula de Fridericia (QTcF) >450 ms o la presencia de cualquier anomalía cardíaca significativa.
    * Según el investigador, el sujeto o sus padres/cuidadores no pueden cumplir con el protocolo, incluido el requisito de viajar a los centros de estudio para las visitas, o son inadecuados por cualquier motivo.
    * Haber intentado suicidarse en el último año o presentar un considerable potencial de suicidio (ya sea según el criterio del investigador o definido como un “sí” a las preguntas 4 o 5 de ideas de suicidio o un “sí” a la conducta suicida en la Escala Columbia para Evaluar el Riesgo de Suicidio [C-SSRS] en los últimos 12 meses).
    * Mujeres embarazadas o en periodo de lactancia.
    * Presentar antecedentes de resultados positivos de inmunoglobulina M del virus de la hepatitis A (VHA-IgM), antígeno de superficie del virus de la hepatitis B (AgHBs) o anticuerpos del virus de la inmunodeficiencia humana (VIH-Ab) al momento de la selección. Se permitirá participar en el estudio a los sujetos con resultados positivos de anticuerpos contra el virus de la hepatitis C (VHC-Ab) y resultados positivos confirmatorios de la prueba de reflejo de la reacción en cadena de la polimerasa (RCP) en la selección, siempre que el sujeto sea asintomático según la evaluación del investigador y no presente anomalías excluyentes en las pruebas de la función hepática (ALAT, ASAT y bilirrubina total).
    * Haber ingerido zumo de pomelo o productos de pomelo en un periodo de 7 días antes del día -1.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change from baseline in 28-day seizure frequency for countable motor seizures during the treatment period of the study.
    Cambio porcentual desde el inicio en 28-dias con frecuencia de convulsiones por convulsiones motoras contables durante el periodo de tratamiento del estudio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time Frame: Baseline, Treatment Period: Day 1 to Week 16
    Marco de tiempo: Inicio, Periodo de tratamiento: Día 1 a Semana 16
    E.5.2Secondary end point(s)
    • Treatment response of ≥ 50% decrease for countable motor seizures
    • Treatment response of ≥ 25%, ≥ 75%, or 100% decrease in countable motor seizures
    • Clinical Global Impression of Change (CGIC) at each study visit
    • Parent/Caregiver Global Impression of Change (GIC) at each study visit
    • Change from Baseline in Clinical Global Impression of Severity (CGIS)
    • Change from Baseline in Parent/Caregiver Global Impression of Severity (GIS)

    Other secondary endpoints (maintenance period):
    -Percentage Change from Baseline in 28-day Seizure Frequency for countable motor seizures
    -Treatment response of ≥ 25%, ≥ 50%, ≥ 75%, or 100% decrease for countable motor seizures
    • Respuesta al tratamiento de ≥ 50% de disminución para convulsiones motoras contables
    • Respuesta al tratamiento de ≥ 25%, ≥ 75% o 100% de disminución en las convulsiones motoras contables
    • Impresión clínica global del cambio (CGIC) en cada visita del estudio
    • Impresión global del cambio (GIC) de los padres / cuidadores en cada visita del estudio
    • Cambio desde la línea de base en la Impresión Clínica Global de Severidad (CGIS)
    • Cambio con respecto a la línea de base en la Impresión global de gravedad (GIS) de los padres / cuidadores

    Otros criterios de valoración secundarios (período de mantenimiento):
    -Porcentaje de cambio con respecto al valor inicial en la frecuencia de convulsiones a los 28 días para convulsiones motoras contables
    -Respuesta al tratamiento de ≥ 25%, ≥ 50%, ≥ 75% o 100% de disminución para las convulsiones motoras contables
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time Frame: Baseline, Treatment Period: Day 1 to Week 16.

    Other secondary endpoints (maintenance period):
    Timeframe: Maintenance Period: Week 7 to Week 16
    Marco de tiempo: línea de base, período de tratamiento: día 1 a la semana 16.

    Otros criterios de valoración secundarios (período de mantenimiento):
    Plazo: Periodo de mantenimiento: Semana 7 a Semana 16
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Brazil
    Canada
    New Zealand
    United States
    Belgium
    Denmark
    France
    Germany
    Italy
    Netherlands
    Poland
    Portugal
    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
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 23
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 23
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 7
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The study population may include adult subjects who are not capable of providing consent due to developmental delay and cognitive impairment common in patients with SCN8A-DEE.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 60
    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.
    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 Decision2021-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-16
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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