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    Summary
    EudraCT Number:2020-002463-61
    Sponsor's Protocol Code Number:JZP385-201
    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 number2020-002463-61
    A.3Full title of the trial
    A Phase 2b, 12-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP385 in the Treatment of Adults with Moderate to Severe Essential Tremor
    Estudio de fase IIb, multicéntrico, aleatorizado, con doble enmascaramiento, controlado con placebo, de grupos paralelos y de 12 semanas de duración para evaluar la seguridad y la eficacia de JZP385 en el tratamiento de adultos con temblor esencial entre moderado y grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of JZP385 in Adults with Moderate to Severe Essential Tremor (ET)
    Estudio de JZP385 en Adultos con temblor esencial (TE) entre moderado y grave
    A.4.1Sponsor's protocol code numberJZP385-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05122650
    A.5.4Other Identifiers
    Name:INDNumber:130296
    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 SponsorCavion, Inc., a subsidiary of Jazz Pharmaceuticals, 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 supportCavion, Inc., a subsidiary of Jazz Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJazz Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointMedical Monitor for JZP385-201
    B.5.3 Address:
    B.5.3.1Street Address3170 Porter Drive
    B.5.3.2Town/ cityPalo Alto, CA
    B.5.3.3Post code94304
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16504963777
    B.5.6E-mailEU&RoW.ClinicalTrialsMailbox@jazzpharma.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 CX-8998
    D.3.4Pharmaceutical form Capsule
    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 INNSuvecaltamide
    D.3.9.1CAS number 2249709-38-2
    D.3.9.2Current sponsor codeJZP385
    D.3.9.4EV Substance CodeSUB216125
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code CX-8998
    D.3.4Pharmaceutical form Capsule
    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 INNSuvecaltamide
    D.3.9.1CAS number 2249709-38-2
    D.3.9.2Current sponsor codeJZP385
    D.3.9.4EV Substance CodeSUB216125
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    Essential Tremor (ET)
    temblor esencial (TE)
    E.1.1.1Medical condition in easily understood language
    Essential tremor is a nervous system (neurological) disorder that causes
    involuntary and rhythmic shaking
    El temblor esencial es un trastorno del sistema nervioso (neurológico) que causa
    temblores involuntarios y rítmicos
    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 PT
    E.1.2Classification code 10015496
    E.1.2Term Essential tremor
    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
    To evaluate the efficacy of JZP385 to improve the functional impact of tremor when administered once daily for up to 12 weeks at fixed doses of 10, 20, and 30 mg/day.
    Evaluar la eficacia de JZP385 en la mejora del impacto funcional del temblor al administrarse una vez al día durante un máximo de 12 semanas, en dosis fijas de 10, 20 y 30 mg/día.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of JZP385 to improve the clinician’s assessment of the ability to function due to ET when administered once daily for up to 12 weeks at fixed doses of 10, 20, and 30 mg/day.

    To evaluate the efficacy of JZP385 to improve overall ET when administered once daily for up to 12 weeks at fixed doses of 10, 20, and 30 mg/day.

    To evaluate the safety and tolerability of JZP385 administered once daily for up to 12 weeks at fixed doses of 10, 20, and 30 mg/day in the treatment of adult participants with ET.
    Evaluar la eficacia de JZP385 en la mejora de la evaluación del médico de la capacidad para funcionar debida al TE al administrarse una vez al día durante un máximo de 12 semanas, en dosis fijas de 10, 20 y 30 mg/día.

    Evaluar la seguridad y la tolerabilidad de JZP385 al administrarse una vez al día durante un máximo de 12 semanas, en dosis fijas de 10, 20 y 30 mg/día, para el tratamiento de participantes adultos con temblor esencial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent.
    2. Participants who are diagnosed with ET (including ET plus) according to the MDS Consensus Statement on the Classification of Tremors from the Task Force on Tremor of the International Parkinson's and Movement Disorder Society.
    3. Participants have moderate to severe disability associated with tremor as determined by a score of ≥ 22 on the TETRAS-ADL subscale; and a score of > 5 on the sum of items 6 and 7 of the TETRAS-PS; and a CGI-S rating of at least moderate for participants' ability to function.
    4. Sex and Contraceptive/Barrier Requirements
    During the study intervention and for at least 30 days after the last dose of study intervention male participants must refrain from donating sperm. Non-abstinent males must agree to use a male condom in combination with female partner use of a highly effective contraceptive method with a failure rate of < 1% per year. All male participants must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.
    Female participants must not be pregnant or breastfeeding, are either women of non-childbearing potential (WONCBP), or are women of childbearing potential (WOCBP) using a highly effective contraceptive method with a failure rate of < 1% during the study intervention period and for at least 30 days after the last dose of study intervention. Male partners of WOCBP are required to use barrier protection, eg, condoms, over the same 30 day period.
    1. El participante debe tener entre 18 y 80 años de edad, inclusive, en el momento de firmar el consentimiento informado.
    2. Participantes con diagnóstico de TE (incluido TE asociado a otros trastornos) según la Guía de Práctica Clínica de la Asociación de Discinesias sobre la Clasificación de los Temblores (MDS Consensus Statement on the Classification of Tremors) del Grupo de Trabajo sobre el Temblor de la Asociación de Discinesias y Parkinson (Task Force on Tremor of the International Parkinson’s and Movement Disorder Society)
    3. Participantes con una discapacidad entre moderada y grave, asociada al temblor, tanto en la visita de selección como en la visita inicial, determinada conforme a Puntuación ≥22 en la subescala TETRAS-ADL, y Puntuación >5 en la suma de los ítems 6 y 7 de la TETRAS-PS y Puntuación mínima de moderada en la CGI-S en cuanto a la capacidad funcional de los participantes.
    4. Requisitos sobre relaciones sexuales y métodos anticonceptivos/de barrera
    Durante el periodo intervencionista del estudio y un mínimo de 30 días tras la última dosis del tratamiento del estudio los participantes de sexo masculino deben abstenerse de donar semen. Los que no se abstengan deben aceptar utilizar un preservativo masculino con una pareja femenina que use un método anticonceptivo adicional de gran eficacia, es decir, con una tasa de error anual <1 %. Todos los hombres participantes deben aceptar utilizar un preservativo masculino al participar en cualquier actividad que posibilite el paso de semen eyaculado a otra persona.
    Una participante de sexo femenino no debe estar embarazada ni en periodo de lactancia y tampoco es una mujer con posibilidad de quedarse embarazada (MPQE) utiliza un método anticonceptivo de gran eficacia, con una tasa de error <1 % durante el periodo intervencionista del estudio y un mínimo de 30 días tras la última dosis del tratamiento del estudio. Nota: además de la anticoncepción hormonal, se requiere que las parejas masculinas de las MPQE utilicen una protección de barrera (como los preservativos) durante el mismo periodo de 30 días
    E.4Principal exclusion criteria
    1. Known history or current evidence of other medical or neurological conditions that may cause or explain the participant's tremor.
    2. Severe cognitive impairment as defined by a Montreal Cognitive Assessment (MoCA; score <23), or has cognitive impairment that in the opinion of the investigator would prevent completion of study procedures or the ability to provide informed consent.
    3. Current suicidal risk as determined from history, by presence of active suicidal ideation as indicated by positive response to item 4 or 5 on the C-SSRS (within the past 24 months), or any history of suicide attempt; current or past (within 1 year) major depressive episode according to DSM-5 criteria.
    4. History (within past 2 years at screening) or presence of substance use disorder (including alcohol) according to DSM-5 criteria, known drug dependence, or seeking treatment for alcohol or substance abuse related disorder. Nicotine use disorder is excluded if it impacts tremor.
    5. Prior magnetic resonance (MR)-guided focused ultrasound, surgical intervention (eg, deep brain stimulation, ablative thalamotomy, gamma knife thalamotomy), or inability to refrain from using a device for treatment of tremor for the duration of the treatment period.
    6. Botulinum toxin injection in the 6 months before screening or planned use at any time during the study.
    7. Treatment with any medication that could affect the evaluation of tremor within 2 weeks or 5 half-lives (whichever is longer) before screening or planned use at any time during the study.
    8. Use of prescription or nonprescription drugs or other products known to be inducers of CYP3A4 that are known to decrease AUC by > 30%,, which cannot be discontinued at least 4 weeks before Baseline, or planned use at any time during the study.
    9. Use of prescription or nonprescription drugs, or other products (eg, grapefruit, grapefruit juice, or Seville oranges) known to be strong or moderate inhibitors of CYP3A4 , that cannot be discontinued 2 weeks or 5 half-lives, whichever is longer, before Baseline or planned use at any time during the study.
    10. Use of proton pump inhibitors and histamine-2 receptor antagonists, which cannot be discontinued at least 2 weeks before Baseline, or planned use at any time during the study (occasional use of antacids will be permitted, but antacids should be taken at least 4 hours apart from study intervention).
    11. Inability to refrain from use of medication/substance(s) that might produce tremor or interfere with the evaluation of tremor on study visit days, such as, but not limited to, stimulant decongestants, beta-agonist bronchodilators, and alcohol.
    12. Regular use of more than 3 units of alcohol per day.
    13. Regular consumption of caffeine > 400 mg/day or > 4 cups of coffee per day.
    1. Antecedentes conocidos o signos actuales de otros trastornos médicos o neurológicos que puedan causar o explicar el temblor del participante,
    2. Presencia en la selección de indicios de deterioro cognitivo grave, según lo definido por una Evaluación Cognitiva de Montreal (Montreal Cognitive Assessment [MoCA]; puntuación <23), o de un deterioro cognitivo que, según el criterio del investigador, impediría que el paciente completara los procedimientos del estudio o que pudiera otorgar su consentimiento informado.
    3. Riesgo actual de suicidio según lo determinado por los antecedentes, presencia de ideas activas de suicidio conforme a lo indicado por una respuesta positiva en el ítem 4 o 5 en la C-SSRS (en los últimos 24 meses), o cualquier antecedente de intento de suicidio; episodio de depresión mayor, actual o previo (durante el último año) según los criterios del DSM-5
    4. Antecedentes (durante los 2 años anteriores a la selección) o presencia de trastornos por consumo excesivo de sustancias adictivas (incluido el alcohol) según los criterios del DSM-5, drogadicción conocida o búsqueda de tratamiento por un trastorno relacionado con el consumo excesivo de alcohol u otras sustancias adictivas. El trastorno por el consumo de nicotina es excluyente si repercute en el temblor.
    5. Tratamiento previo con ultrasonidos focalizados guiados por resonancia magnética, intervenciones quirúrgicas (p. ej., estimulación de estructuras encefálicas profundas, talamotomía por ablación o talamotomía con bisturí de rayos γ) o incapacidad para abstenerse de utilizar un dispositivo para el tratamiento del temblor durante el periodo de tratamiento.
    6. Inyección de toxina botulínica durante los 6 meses anteriores a la selección o tener previsto su uso en cualquier momento durante el estudio.
    7. Tratamiento con cualquier medicamento que pueda influir en la evaluación del temblor durante un plazo de 2 semanas o 5 semividas (el periodo que sea más largo) antes de la evaluación del temblor en la selección o tener previsto su uso en cualquier momento durante el estudio.
    8. Uso de fármacos de venta con receta o sin receta u otros productos inductores de CYP3A4 que reducen el AUC en >30 % que no puedan interrumpirse un mínimo de 4 semanas antes del momento inicial, o tener previsto su uso en cualquier momento durante el estudio.
    9. Uso de fármacos de venta con receta o sin receta u otros productos (p. ej., pomelo, zumo de pomelo o naranjas amargas) que sean inhibidores potentes o moderados de CYP3A4 y no puedan interrumpirse 2 semanas o 5 semividas, el periodo que sea más largo, antes del momento inicial, o tener previsto su uso en cualquier momento durante el estudio.
    10. Uso de inhibidores de la bomba de protones y antihistamínicos H2 que no puedan interrumpirse un mínimo de 2 semanas antes del momento inicial, o tener previsto su uso en cualquier momento durante el estudio (se permite el uso ocasional de antiácidos, pero estos deberán tomarse con un intervalo mínimo de 4 horas entre su ingesta y la del tratamiento del estudio).
    11. Incapacidad para abstenerse de usar medicamentos o sustancias que pueden producir temblor o interferir en la evaluación del temblor en los días de las visitas del estudio, como, entre otros, los descongestivos estimuladores, los broncodilatadores agonistas β y el alcohol.
    12. Consumo habitual de más de 3 unidades de alcohol al día
    13. Consumo habitual de cafeína >400 mg/día o >4 tazas de café al día.
    E.5 End points
    E.5.1Primary end point(s)
    -Difference in the mean Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) composite outcome score(a) from Baseline to Week 12 between each dose of JZP385 and placebo.

    (a) The TETRAS composite outcome score consists of the sum of modified items 1 to 11 of the TETRAS Activities of Daily Living (TETRAS-ADL) subscale and modified items 6 and 7 of the TETRAS Performance Subscale (TETRAS-PS).
    -Diferencia en la puntuación media de la puntuación del resultado combinado de la TETRASa, entre el nivel basal y la semana 12, entre cada dosis de JZP385 y el placebo

    (a) El criterio de valoración principal del estudio es una combinación de la suma de los elementos modificados 1 a 11 de la subescala de Actividades de la vida cotidiana (TETRAS-ADL) y los elementos modificados 6 y 7 de la subescala de rendimiento (TETRAS-PS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline and week 12
    basal y semana 12
    E.5.2Secondary end point(s)
    Efficacy
    -Difference in the mean Clinical Global Impression of Severity (CGI-S) score from Baseline to Week 12 between each dose of JZP385 and placebo
    -Percentage of participants reported as much improved at Week 12 relative to baseline on the:
    -Clinical Global Impression of Change (CGI-C)
    -Patient Global Impression of Change (PGI-C)
    -Change from Baseline to Week 12, as summarized by each dose of JZP385 and placebo, on the:
    -TETRAS-ADL
    -TETRAS-PS
    -Upper limb score (item 4) of the TETRAS-PS
    -TETRAS total score
    -Quality of Life in Essential Tremor (QUEST)
    -Essential Tremor Embarrassment Assessment (ETEA)

    Safety
    The occurrence of and/or change in:
    -Treatment-emergent adverse events (TEAEs)
    -Safety laboratory assessments
    -Vital signs
    -12-lead electrocardiogram (ECG)
    -Columbia Suicide Severity Rating Scale (C-SSRS)
    -Physical exam
    Eficacia
    -diferencia entre las puntuaciones medias de la CGI-S entre el nivel basal y la semana 12 entre cada dosis de JZP385 y el placebo
    -Porcentaje de participantes en los que se notifica una mejoría considerable en la CGI-C en la semana 12 respecto a basal en:
    -Impresión clínica global del cambio (CGI-C)
    -Impresión global del cambio por parte del paciente (PGI-C)

    Cambio del valor inicial a la semana 12, según lo resumido por cada dosis de JZP385 y placebo, en:
    - TETRAS-ADL
    - TETRAS-PS
    - puntuación TETRAS de las extremidades superiores (elemento 4)
    - puntuación TETRAS total
    - Cuestionario sobre la calidad de vida de pacientes con temblor esencial (QUEST)
    - Evaluación de la vergüenza asociada al temblor esencial (ETEA)

    Seguridad
    Incidencia y/o cambio en
    - acontecimientos adversos surgidos durante el tratamiento (AAST),
    - evaluación de las pruebas analíticas de seguridad,
    - constantes vitales,
    - resultados del ECG,
    - resultados en la Escala de Columbia para evaluar la intensidad de las ideas de suicidio (C-SSRS)
    - hallazgos de la exploración física.
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline to week 12
    basal a semana 12
    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
    tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Poland
    Spain
    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 ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 297
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 103
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 162
    F.4.2.2In the whole clinical trial 400
    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 Decision2022-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-11
    P. End of Trial
    P.End of Trial StatusOngoing
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