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    Summary
    EudraCT Number:2021-002482-17
    Sponsor's Protocol Code Number:TAK-935-3003
    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:2021-12-20
    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 number2021-002482-17
    A.3Full title of the trial
    A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2).
    Estudio fase 3 prospectivo, abierto, multicéntrico y de extensión de los estudios Fase 3, para evaluar la seguridad y tolerabilidad a largo plazo de Soticlestat como tratamiento adyuvante en pacientes con Síndrome Dravet o Síndrome de Lennox-Gastaut (ENDYMION 2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-Label Extension Study of Soticlestat in Dravet and Lennox-Gastaut Syndromes
    Estudio abierto de extension de Soticlestat en Síndrome Dravet y Lennox -Gastaut
    A.4.1Sponsor's protocol code numberTAK-935-3003
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/317/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Development Center Americas, 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 supportTakeda Development Center Americas, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Development Center Americas, Inc.
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address95 Hayden Avenue
    B.5.3.2Town/ cityLexington, MA
    B.5.3.3Post code02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900 834 223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 namesoticlestat
    D.3.2Product code TAK-935
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPGastroenteral use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSOTICLESTAT
    D.3.9.1CAS number 1429505-03-2
    D.3.9.2Current sponsor codeTAK-935
    D.3.9.4EV Substance CodeSUB198078
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 namesoticlestat
    D.3.2Product code TAK-935
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPGastroenteral use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSOTICLESTAT
    D.3.9.1CAS number 1429505-03-2
    D.3.9.2Current sponsor codeTAK-935
    D.3.9.4EV Substance CodeSUB198078
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dravet Syndrome (DS)
    Lennox-Gastaut Syndrome (LGS)
    Síndrome Dravet
    Síndrome Lennox Gastaut
    E.1.1.1Medical condition in easily understood language
    seizures
    Convulsiones
    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 LLT
    E.1.2Classification code 10073682
    E.1.2Term Dravet syndrome
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10048816
    E.1.2Term Lennox-Gastaut syndrome
    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 long-term safety and tolerability of soticlestat when administered as adjunctive therapy to SOC (eg, ASMs, vagus nerve stimulation, ketogenic diet, modified Atkins diet) in subjects with DS or LGS.
    El objetivo principal de este estudio es evaluar la seguridad y la tolerabilidad a largo plazo de soticlestat cuando se administra como tratamiento complementario del tratamiento de referencia (p. ej., FAE, estimulación del nervio vago, dieta cetógena, dieta Atkins modificada) en pacientes con SD o SLG.
    E.2.2Secondary objectives of the trial
    - To assess the effect of soticlestat on seizure frequency (convulsive seizures for the DS cohort, MMD seizures for the LGS cohort, and total seizure count for each cohort).
    - To assess the effect of soticlestat on the Clinical Global Impression of Improvement (CGI-I) (clinician) and Caregiver Global Impression of Improvement (Care GI-I).
    - To assess the effect of soticlestat on CGI-I Seizure Intensity and Duration.
    - To assess the effect of soticlestat on the CGI-I Nonseizure Symptoms completed by clinician with input from the caregiver.
    - To assess the effect on Quality of Life Inventory-Disability (QI-Disability).
    -Evaluar el efecto del soticlestat sobre la frecuencia de las crisis (crisis convulsivas en la cohorte de SD, crisis atónicas generalizadas en la cohorte de SLG y número total de crisis en cada cohorte).
    -Evaluar el efecto del soticlestat en la Impresión clínica global de mejoría (CGI-I) (médico) y la Impresión global de mejoría del cuidador (Care GI-I).
    -Evaluar el efecto del soticlestat sobre la Intensidad y la duración de las crisis en la CGI-I.
    -Evaluar el efecto del soticlestat sobre los Síntomas no convulsivos en la CGI-I completados por el médico con la información aportada por el cuidador.
    -Evaluar el efecto sobre el Cuestionario de calidad de vida-Discapacidad (QI-Discapacidad).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject must have:
    Been previously enrolled in soticlestat clinical study TAK-935-3001 or TAK-935-3002.
    1. Received at least 12 weeks of treatment (combined titration and Maintenance Period) with the study drug in the antecedent study and not have a serious or severe AE that, in the investigator’s or sponsor’s opinion, was related to the study drug and would make it unsafe for the patient to continue receiving the study drug.
    2. In the opinion of the investigator, the subject has the potential to benefit from the administration of soticlestat.
    3. In the opinion of the investigator, the subject and/or parent or legal guardian is capable of understanding and complying with protocol requirements including the use of digital tools, complete appropriate assessments, maintain an accurate and complete daily seizure diary and take study drug for the duration of the study.
    4. The subject or the subject’s parent or legal guardian are willing and able to read, understand, and sign and date a written or an electronic informed consent form (ICF), assent form (if applicable), and any required privacy authorization prior to the initiation of any study procedures.
    5. Female subjects of childbearing potential (defined as first menarche) must have a negative pregnancy test and agree to use an effective method of birth control during the study and for 30 days following the last dose of study drug.
    Effective contraceptive methods are as follows:
    -Double-barrier method (contraceptive sponge, diaphragm, or cervical cap with spermicidal jellies or creams PLUS male condom).
    - Partner with male condom.
    -Combined or progestogen-only hormonal contraception
    -Intrauterine device (Copper T PLUS condom)
    - Intrauterine hormone-releasing system
    - Sexual abstinence:
    i. Sexual abstinence may be considered as a method only if defined as refraining from heterosexual intercourse and determined to be the usual lifestyle before entering the study with reliability of abstinence for the duration of the study participation and for 30 days after last dose of study drug.
    -Sterilization:
    ii. Bilateral tubal occlusion.
    iii. Vasectomized partner (provided that the partner is the sole sexual partner of the subject and the absence of sperm in the ejaculate has been confirmed).
    El paciente debe haber:
    -Participado previamente en uno de los estudios clínicos de soticlestat TAK-935-3001 o TAK-935-3002.
    -Recibido al menos 12 semanas de tratamiento (período de ajuste y mantenimiento de la dosis combinados) con el fármaco del estudio en el estudio previo y no haber presentado ningún AA grave o intenso que, en opinión del investigador o del promotor, esté relacionado con el fármaco del estudio y haga que no sea seguro para el paciente seguir recibiendo el fármaco del estudio.
    2. En opinión del investigador, el paciente puede beneficiarse de la administración de soticlestat.
    3. Según la opinión del investigador, el paciente y/o padre, madre o tutor legal es capaz de comprender y cumplir los requisitos del protocolo, incluido el uso de herramientas digitales, realizar las evaluaciones pertinentes, mantener un diario de crisis exacto y completo y tomar el fármaco del estudio durante todo el estudio.
    4. El paciente o el padre, madre o tutor legal del paciente está dispuesto y es capaz de leer, entender y firmar y fechar un documento de consentimiento informado (DCI) por escrito o electrónico, un documento de asentimiento (si corresponde) y cualquier autorización sobre protección de datos necesaria antes del inicio de los procedimientos del estudio.
    5. Las mujeres en edad fértil (las que han tenido la menarquia) deberán tener una prueba de embarazo negativa y comprometerse a utilizar un método anticonceptivo eficaz durante el estudio y durante 30 días después de la última dosis del fármaco del estudio.
    Los métodos anticonceptivos eficaces son los siguientes:
    -Método de doble barrera (esponja anticonceptiva, diafragma o capuchón cervical con gel o crema espermicida MÁS preservativo masculino).
    -Uso de preservativo por la pareja.
    -Anticonceptivos hormonales combinados o solo con progestágenos.
    -Dispositivo intrauterino (T de cobre Y preservativo).
    -Sistema intrauterino liberador de hormonas.
    -Abstinencia sexual:
    i.La abstinencia sexual solo podrá considerarse un método si se define como la ausencia de relaciones heterosexuales y se determina que es el modo de vida habitual antes de la incorporación al estudio; la abstinencia deberá mantenerse durante toda la participación en el estudio y durante los 30 días siguientes a la última dosis del fármaco del estudio.
    -Esterilización:
    ii.Ligadura de trompas bilateral.
    iii.Vasectomía de la pareja (siempre que sea la única pareja sexual de la paciente y se haya confirmado la ausencia de espermatozoides en el eyaculado).
    E.4Principal exclusion criteria
    1. Unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive tumors, or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the medical monitor may be warranted.
    2. Abnormal and clinically significant ECG abnormality at Visit 1 including QT interval with Fridericia correction method (QTcF) >450 ms confirmed with a repeat ECG using manual measurement of QTcF. Clinically significant ECG abnormalities should be discussed with the medical monitor.
    3. Subject is currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last dose of study drug.
    4. Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Subjects who have positive answers on item numbers 4 or 5 on the CSSRS before dosing are excluded. This scale will only be administered to subjects aged ≥6 years.
    1.Enfermedad neurológica (aparte de la estudiada), psiquiátrica, cardiovascular, oftalmológica, pulmonar, hepática, renal, metabólica, digestiva, urológica, inmunológica, hematopoyética o endocrina inestable y de importancia clínica, neoplasia maligna, incluidos los tumores progresivos, u otra anomalía que pueda influir en la capacidad para participar en el estudio o que pueda confundir los resultados del estudio. Es responsabilidad del investigador evaluar la importancia clínica; sin embargo, puede estar justificada la consulta con el monitor médico.
    2.Anomalía del ECG de importancia clínica en la visita 1, incluido un intervalo QT con el método de corrección de Fridericia (QTcF) >450 ms, confirmado con un nuevo ECG utilizando medición manual del QTcF. Las anomalías ECG de importancia clínica se comentarán con el monitor médico.
    3.La paciente está embarazada o en período de lactancia o tiene previsto quedarse embarazada durante el estudio o en los 30 días siguientes a la última dosis del fármaco del estudio.
    4.El investigador considera que el paciente corre un riesgo inminente de suicidio o de lesionarse a sí mismo, a los demás o de causar daños materiales. Se excluirá a los pacientes con respuestas positivas en los ítems número 4 o 5 del C-SSRS antes de la administración. Esta escala sólo se aplicará a pacientes de 6 años o más.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of TEAEs.
    - Change from baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) categorization based on Columbia Classification Algorithm of Suicide Assessment categories 1, 2, 3, 4, and 5 for patients ≥6 years of age.
    - Incidence of clinically significant abnormal safety laboratory test values, vital signs and electrocardiogram (ECG) evaluations.
    - Change from baseline in safety laboratory test values, vital signs and ECG evaluations.
    - Change from baseline in height and weight for all age groups, and in absolute value for Tanner stage for children 6 to 17 years and insulin-like growth factor 1 (IGF 1) for children 2 to 17 years of age during the study.
    -Incidencia de AAAT.
    -Variación con respecto al momento basal de la clasificación de la Escala de valoración del riesgo de suicidio de Columbia (C-SSRS) basada en las categorías 1, 2, 3, 4 y 5 del Algoritmo de clasificación de Columbia para la evaluación del riesgo de suicidio en pacientes ≥6 años.
    -Incidencia de valores anómalos clínicamente significativos en las pruebas analíticas de seguridad clínica, constantes vitales y evaluaciones electrocardiográficas (ECG).
    -Variación con respecto al momento basal de los valores en las pruebas analíticas de seguridad, constantes vitales y ECG.
    -Variación con respecto al momento basal de la estatura y el peso en todos los grupos de edad, del valor absoluto del estadio de Tanner en niños de 6 a 17 años y del factor de crecimiento insulínico 1 (IGF 1) en niños de 2 a 17 años durante el estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary end points will be assessed throughout the study.
    Los criterios de valoración principal se evaluarán a lo largo de todo el
    estudio
    E.5.2Secondary end point(s)
    - Percent change from baseline in total seizure frequency per 28 days for each (DS and LGS) cohort.
    - Percent change from baseline in convulsive seizure frequency (DS) per 28 days.
    - Percent change from baseline in MMD seizure frequency (LGS) per 28 days.
    - Effect on the CGI-I and Care GI-I.
    - Effect on CGI-I Seizure Intensity and Duration.
    - Effect on the CGI-I Nonseizure Symptoms completed by clinician with input from the caregivers.
    - Effect on QI-Disability.
    -Variación porcentual con respecto al momento basal de la frecuencia total de crisis en 28 días en cada cohorte (SD y SLG).
    -Variación porcentual con respecto al momento basal de la frecuencia de crisis convulsivas (SD) en 28 días.
    -Variación porcentual con respecto al momento basal de la frecuencia de crisis atónicas generalizadas en 28 días.
    -Efecto en las escalas CGI-I y Care GI-I.
    -Efecto sobre la Intensidad y la duración de las crisis en la CGI-I.
    -Efecto sobre los Síntomas no convulsivos en la CGI-I completada por el médico con la información aportada por los cuidadores.
    -Efecto sobre el cuestionario QI-Discapacidad.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points will be assessed throughout the study.
    Los criterios de valoración secundarios se evaluarán a lo largo de todo el
    estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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
    Australia
    Serbia
    Belgium
    Canada
    China
    Greece
    Hungary
    Italy
    Japan
    Latvia
    Netherlands
    Poland
    Russian Federation
    Spain
    Ukraine
    United States
    France
    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
    The end of the study for an individual subject is defined as the last protocol-specified contact with that subject.
    The overall end of the study is defined as the last protocol-specified contact with the last subject ongoing in the study.
    El final del estudio para un sujeto se define como el último contacto especificado por el protocolo con ese sujeto.
    El final general del estudio se define como el último contacto especificado por el protocolo con el último sujeto en curso en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 264
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 169
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 95
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 112
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 135
    F.4.2.2In the whole clinical trial 376
    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)
    At the end of the maintenance period, whether after the full duration or for early termination, the dose will be tapered for approximately 1 week (unless already at the lowest dose), followed approximately 2 weeks later by a safety follow-up visit or phone call.
    Al final del período de mantenimiento, ya sea después de la duración completa o para la terminación anticipada, la dosis se reducirá durante aproximadamente 1 semana (a menos que ya esté en la dosis más baja), seguida de aproximadamente 2 semanas después mediante una visita de seguimiento de seguridad o una llamada telefónica.
    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 Opinion2022-03-25
    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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