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    Summary
    EudraCT Number:2021-002926-26
    Sponsor's Protocol Code Number:STM-042/K
    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:2021-09-10
    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 number2021-002926-26
    A.3Full title of the trial
    Efficacy, Safety and Tolerability of 3 doses of Sulthiame in Patients with Obstructive Sleep Apnea. A Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study
    Eficacia, seguridad y tolerabilidad de 3 dosis de sultiamo en pacientes con apnea obstructiva del sueño. Un estudio aleatorizado, doble ciego, controlado con placebo y de determinación de dosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, Safety and Tolerability of Sulthiame in Patients with Obstructive Sleep Apnea
    Eficacia, seguridad y tolerabilidad de 3 dosis de sultiamo en pacientes con apnea obstructiva del sueño
    A.4.1Sponsor's protocol code numberSTM-042/K
    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 SponsorDesitin Arzneimittel GmbH
    B.1.3.4CountryGermany
    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 supportDesitin Arzneimittel GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDesitin Arzneimittel GmbH
    B.5.2Functional name of contact pointDr. Corinna Hansen
    B.5.3 Address:
    B.5.3.1Street AddressWeg beim Jäger 214
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code22335
    B.5.3.4CountryGermany
    B.5.4Telephone number+494059101-234
    B.5.6E-mailhansen@desitin.de
    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 Yes
    D.2.1.1.1Trade name Ospolot 50 mg
    D.2.1.1.2Name of the Marketing Authorisation holderDesitin Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Film-coated 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 INNSulthiame
    D.3.9.1CAS number 61-56-3
    D.3.9.4EV Substance CodeSUB10762MIG
    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.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 Yes
    D.2.1.1.1Trade name Ospolot 200 mg
    D.2.1.1.2Name of the Marketing Authorisation holderDesitin Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Film-coated 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 INNSulthiame
    D.3.9.1CAS number 61-56-3
    D.3.9.4EV Substance CodeSUB10762MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Obstructive sleep apnea
    Apnea obstructiva del sueño
    E.1.1.1Medical condition in easily understood language
    Obstructive sleep apnea
    Apnea obstructiva del sueño
    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 10055577
    E.1.2Term Obstructive sleep apnea syndrome
    E.1.2System Organ Class 100000004855
    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 three different doses of Sulthiame (STM) compared to placebo on sleep apnea activity in adult patients with moderate to severe obstructive sleep apnea after at least 12 weeks of treatment at target dose.
    Evaluar la eficacia de 3 dosis diferentes de sultiamo (STM) en comparación con placebo sobre la actividad de la apnea del sueño en pacientes adultos con apnea obstructiva del sueño (AOS) de moderada a grave después de al menos 12 semanas de tratamiento con la dosis objetivo.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of three different doses of STM after at least 12 weeks of treatment at target dose in patients with moderate to severe obstructive sleep apnea (OSA) on:
    - apnea/hyponea events
    - hypoxic burden
    - sleep quality
    - daytime sleepiness
    - patient’s symptoms and well-being
    - comorbidity-related outcomes
    - safety and tolerability of STM
    Evaluar el efecto de 3 dosis diferentes de STM después de al menos 12 semanas de tratamiento con la dosis objetivo en pacientes con apnea obstructiva del sueño (AOS) de moderada a grave sobre:
    - los episodios de apnea/hipopnea
    - la carga hipóxica, la calidad del sueño
    - la somnolencia diurna
    - la percepción de síntomas y bienestar por parte del paciente
    - los resultados relacionados con la comorbilidad
    - la seguridad y la tolerabilidad de STM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to provide written informed consent
    2. Male or female aged 18 to 75 years inclusive
    3. OSA diagnosis according to the international classification of sleep disorders (ICSD)-3 criteria with an AHI ≥15 documented by PSG or polygraphy (PG)
    4. Currently not treated with CPAP or MAD (see further details in the protocol)
    5. An AHI of ≥15 to ≤50 (mean from 2 PSG recordings [2 nights] at baseline), AHI of at least 10 on each night
    6. BMI ≥18.5 kg/m2 and ≤35 kg/m2
    7. Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP must be able and willing to use at least 1 highly effective method of contraception for at least 2 months prior to the first dose of study drug, throughout the entire study period, and for 30 days after the last dose of study drug
    8. Willing and able to comply with the study design schedule and other requirements
    1. Estar dispuesto y ser capaz de dar un consentimiento informado por escrito
    2. Hombre o mujer de 18 a 75 años inclusive
    3. Diagnóstico de AOS de acuerdo con los criterios de la Clasificación Internacional de Trastornos del Sueño - Tercera Edición con un IAH de ≥ 15 documentado mediante PSG o poligrafía (PG).
    4. Sin tratamiento actual con presión positiva continua en las vías respiratorias (CPAP, continuous positive airway pressure) o dispositivo de avance mandibular (DAM) (ver protocolo para más detalles)
    5. Un IAH de ≥ 15 a ≤ 50 (media de 2 registros de PSG [2 noches] al inicio), con un IAH de al menos 10 cada noche.
    6. IMC ≥ 18,5 kg/m2 y ≤ 35 kg /m2.
    7. Las mujeres en edad fértil (MEF) o los hombres cuyas parejas sexuales sean MEF deben poder y estar dispuestos a utilizar al menos un método anticonceptivo de alta eficacia durante el estudio y durante dos semanas después de la última dosis del fármaco del estudio. En el caso de los métodos anticonceptivos hormonales, debe utilizarse una barrera adicional.
    8. Disposición y capacidad para cumplir con el calendario del estudio y otros requisitos.
    E.4Principal exclusion criteria
    1. Any OSA treatment within the last 4 weeks prior to screening
    2. Fulfilling criteria for a dominant central sleep apnea syndrome or a dominant Cheyne Stokes respiration
    3. Other clinically significant sleep disorder including periodic limb movement disorder, restless leg syndrome, periodic limb movements arousal index (PLMAI) >15, insomnia, parasomnia or narcolepsy
    4. Hypoventilation or hypoxemia due to chronic obstructive pulmonary disease or other respiratory condition
    5. Clinically relevant craniofacial malformation
    6. Any upper airway surgery for OSA within the last 12 months prior to baseline
    7. Patients who underwent an obesity surgery within the last 2 years prior to baseline or patients actively participating in any weight loss treatment program or use of any weight loss medication (prescription or over-the-counter) within 2 months prior to the first PSG night
    8. Elevated blood pressure or uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg). If treated, patients must have been on the same dose of antihypertensive medication for at least 4 weeks prior to screening
    9. Uncontrolled congestive heart failure
    10. Myocardial infarction or coronary vessel intervention within the previous 6 months period or unstable angina pectoris
    11. Previously diagnosed or treated clinically significant cardiac arrhythmia
    12. Episode of major depression, bipolar disorder, or any other significant psychiatric disorder within the last 12 months prior to screening
    13. Significant neurological or cognitive disorders as detailed in the protocol
    14. Renal or hepatic failure as defined in the protocol
    15. History of severe allergy/hypersensitivity or any ongoing allergy/hypersensitivity requiring continuous medical treatment
    16. Known allergy/hypersensitivity to STM and ingredients or to sulfonamides
    17. Nightshift-workers, professional drivers, patients handling complex machinery or with any other occupation where there may be an increased risk for work or traffic accidents
    18. Participation in another clinical study during the last 30 days prior to screening
    19. Planned surgery during the study period or major surgery within 6 months prior to first dose of study drug
    20. History of alcohol or drug abuse during the last year, substance use disorder, positive urine drug screen for drugs of abuse at screening
    21. Intake of any protocol-specified prohibited medication
    22. Clinically significant gastrointestinal, metabolic, urinary, or hematological disorder or any other significant condition that, in the opinion of the investigator, could interfere with participation in the study. Note, acute porphyria and untreated hyperthyroidism are excluded.
    23. Type 1 diabetes or insulin treated type 2 diabetes or poorly controlled type 2 diabetes
    24. Current or active infection
    25. Positive COVID-19 polymerase chain reaction (PCR) test result within 30 days prior to screening or at screening, history of hospitalization for COVID-19 within 30 days prior to screening, or history of use of oxygen due to COVID-19 within 30 days prior to screening. Note that previous COVID-19 infection alone is not exclusionary and vaccination against SARS-CoV-2 is allowed, but must be documented.
    26. Planned COVID-19 vaccination during the trial participation or within 2 weeks prior to screening. Booster vaccinations are allowed.
    27. History of actual suicidal behavior or suicidal ideation of type 2 to 5 within one year prior to screening, or current suicidal ideation of any type (i.e. 1 to 5) as assessed by the C-SSRS at screening
    28. Female patients who are currently pregnant or breastfeeding
    Please see the full list of exclusion criteria in the study protocol.
    1.Cualquier tratamiento para la AOS en las 4 semanas previas a la selección.
    2.Cumplir con los criterios para un síndrome de apnea central del sueño dominante o respiración de Cheyne-Stokes dominante.
    3.Otro trastorno del sueño clínicamente significativo, como trastorno de movimiento periódico de las extremidades, síndrome de piernas inquietas, índice de activación periódica del movimiento de las extremidades (periodic limb movement arousal index, PLMAI) de > 15, insomnio, parasomnia o narcolepsia
    4.Hipoventilación o hipoxemia debido a enfermedad pulmonar obstructiva crónica u otra afección respiratoria.
    5.Malformación craneofacial clínicamente relevante.
    6.Cualquier cirugía de las vías respiratorias superiores para la AOS en los últimos 12 meses previos al inicio.
    7.Pacientes que se han sometido a una cirugía de obesidad en los últimos 2 años antes del inicio del estudio o pacientes que han participado activamente en cualquier programa de tratamiento para bajar de peso o uso de cualquier medicamento para bajar de peso (con o sin receta) en el mes anterior a la primera noche de PSG.
    8.Presión arterial elevada o hipertensión no controlada (presión arterial sistólica ≥ 160 mm Hg y/o presión arterial diastólica ≥ 100 mm Hg). Si reciben tratamiento, los pacientes deben haber estado tomando la misma dosis de medicación antihipertensiva durante al menos 4 semanas antes de la selección.
    9.Insuficiencia cardíaca congestiva no controlada.
    10.Infarto de miocardio o intervención de vasos coronarios en los 6 meses previos o angina de pecho inestable.
    11.Arritmia cardíaca clínicamente significativa previamente diagnosticada o tratada.
    12.Episodio de depresión grave, trastorno bipolar o cualquier otro trastorno psiquiátrico significativo en los últimos 12 meses antes de la selección.
    13.Trastornos neurológicos o cognitivos significativos, como se detalla en el protocolo.
    14.Insuficiencia renal o hepática definida en el protocolo.
    15.Antecedentes de alergia/hipersensibilidad grave o cualquier alergia/hipersensibilidad en curso que requiera tratamiento farmacológico continuo.
    16.Alergia/hipersensibilidad conocida a STM y sus ingredientes o a las sulfonamidas.
    17.Trabajadores del turno de noche, conductores profesionales, pacientes que manipulan maquinaria compleja o pacientes con cualquier otra ocupación donde pueda haber un mayor riesgo de accidentes laborales o de tráfico.
    18.Participación en otro estudio clínico durante los 30 días anteriores a la selección.
    19.Cirugía planificada durante el periodo del estudio o cirugía mayor en los 6 meses previos a la primera dosis del fármaco del estudio.
    20.Antecedentes de abuso de alcohol o drogas durante el último año, trastorno por uso de sustancias o prueba de detección de drogas en orina positiva en la selección.
    21.Toma de cualquier medicamento prohibido especificado por el protocolo.
    22.Trastorno gastrointestinal, metabólico, urinario o hematológico clínicamente significativo o cualquier otra afección significativa que, en opinión del investigador, podría interferir en la participación en el estudio. Tenga en cuenta que se excluyen la porfiria aguda y el hipertiroidismo no tratado.
    23.Diabetes de tipo 1, diabetes de tipo 2 tratada con insulina o diabetes de tipo 2 mal controlada
    24.Infección actual o activa.
    25.Resultado positivo en la prueba de reacción en cadena de la polimerasa (PCR) de COVID-19 en los 30 días anteriores a la selección o en la selección, antecedentes de hospitalización por COVID-19 en los 30 días anteriores a la selección o antecedentes de uso de oxígeno debido a COVID-19 en los 30 días previos a la selección. Téngase en cuenta que la infección previa por COVID-19 por sí sola no es excluyente y se permite la vacunación frente a SARS-CoV-2, pero debe estar documentada)
    26.Vacuna para la COVID-19 planificada durante la participación en el ensayo o en las 2 semanas previas a la selección. Se permiten las vacunas de refuerzo.
    27.Antecedentes de comportamiento suicida real o ideación suicida de tipo 2 a 5 en el año previo a la selección, o ideación suicida actual de cualquier tipo (es decir, 1 a 5) según lo evaluado por la Escala de la Universidad de Columbia para evaluar el riesgo de suicidio (C-SSRS) en la selección.
    28.Pacientes de sexo femenino que tengan previsto quedarse embarazadas o que están actualmente embarazadas o en periodo de lactancia.
    Por favor refiérase a la lista de criterios de exclusión del protocolo del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the relative change in AHI from baseline to Week 15 (at least 12 weeks of treatment at target dose) measured by PSG.
    El criterio principal de este estudio es el cambio relativo en el índice de apnea-hipopnea (IAH) desde el inicio hasta la semana 15 (al menos 12 semanas de tratamiento a la dosis objetivo) determinado mediante PSG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As specified in the endpoints.
    Como se especifica en los criterios.
    E.5.2Secondary end point(s)
    • AHI Responder
    • Change in Oxygen desaturation Index
    • Change in overnight Oxygen Saturation
    • Change in sleep stages
    • Change in sleep quality parameter
    • Patient/Clinical global Impression Scale
    • Change in Epworth Sleepiness Scale
    • Change in Sleep Apnea Quality of Life
    • Change in Pittsburg Sleep Quality Index
    • Change in blood pressure
    •Change in body weight

    For the Efficacy endpoints please refer to section 6.2.2.1. of Final Clinical Study Protocol .
    Criterios de valoración de la seguridad:
    • Índice de desaturación de oxígeno (IDO)
    • Cambio en la saturación media de oxígeno durante la noche
    • Cambio en el tiempo total de sueño
    • Cambio en parámetros de calidad del sueño
    • Escala de impresión global del paciente/clínica global
    • Cambio en Escala de somnolencia de Epworth
    • Cambio en el Índice de calidad de vida relacionada con la apnea del sueño
    • Cambio en Índice de calidad del sueño de Pittsburgh
    • Cambio en la presión arterial
    • Cambio en el peso corporal

    Para los ciriterios de eficacia por favor refiérase a la sección 6.2.2.1 de Protocol Clinico Final del Estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As specified in the endpoints, and in the study procedures (section 10 of the Final Clinical Study Protocol).
    Como se especifica en los criterios, y en los procedimientos del estudio (sección 10 del Protocolo Final del Estudio Clínico).
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    Biomarcadores
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Belgium
    France
    Germany
    Spain
    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 del último paciente (UVUP)
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 148
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 368
    F.4.2.2In the whole clinical trial 368
    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
    Ninguno
    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 Decision2021-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-25
    P. End of Trial
    P.End of Trial StatusOngoing
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