Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43432   clinical trials with a EudraCT protocol, of which   7184   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2019-003532-23
    Sponsor's Protocol Code Number:PBD01180
    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:2021-07-14
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-003532-23
    A.3Full title of the trial
    A Phase 2b Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Dose Finding, Safety, Tolerability and Efficacy Study of PQ912 in Subjects with Mild Cognitive Impairment and Mild Dementia due to Alzheimer’s Disease.
    Ensayo fase 2b, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos en paralelo, de la búsqueda de dosis, seguridad, tolerabilidad y eficacia de PQ912 en sujetos con deterioro cognitivo y demencia leves debidos a la enfermedad de Alzheimer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2b Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Dose Finding, Safety, Tolerability and Efficacy Study of PQ912 in Subjects with Mild Cognitive Impairment and Mild Dementia due to Alzheimer’s Disease.
    Ensayo fase 2b, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos en paralelo, de la búsqueda de dosis, seguridad, tolerabilidad y eficacia de PQ912 en sujetos con deterioro cognitivo y demencia leves debidos a la enfermedad de Alzheimer.
    A.3.2Name or abbreviated title of the trial where available
    VIVIAD study
    A.4.1Sponsor's protocol code numberPBD01180
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03919162
    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 SponsorVivoryon Therapeutics N.V.
    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 supportVivoryon Therapeutics N.V.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVivoryon Therapeutics N.V.
    B.5.2Functional name of contact pointCBO
    B.5.3 Address:
    B.5.3.1Street AddressWeinbergweg 22
    B.5.3.2Town/ cityHalle (Saale)
    B.5.3.3Post code06120
    B.5.4Telephone number493455559900
    B.5.5Fax number493455559901
    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 namePQ912
    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 INNVaroglutamstat
    D.3.9.2Current sponsor codePQ912
    D.3.9.3Other descriptive namePQ912
    D.3.9.4EV Substance CodeSUB120856
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 150
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild Cognitive Impairment and Mild Dementia due to Alzheimer’s Disease
    Deterioro cognitivo y demencia leves debidos a la enfermedad de Alzheimer
    E.1.1.1Medical condition in easily understood language
    Mild Cognitive Impairment and Mild Dementia due to Alzheimer’s Disease
    Deterioro cognitivo y demencia leves debidos a la enfermedad de Alzheimer
    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 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the safety and tolerability of PQ912
    • To evaluate the efficacy of PQ912 on working memory and attention
    • Evaluar la seguridad y tolerabilidad de PQ912
    • Evaluar la eficacia de PQ912 sobre la memoria de trabajo y la atención
    E.2.2Secondary objectives of the trial
    • To assess the safety and tolerability of long-term PQ912
    • To evaluate the efficacy of PQ912 on brain activity (EEG)
    • To evaluate the efficacy of PQ912 on cognition
    • To evaluate the efficacy of PQ912 on activities of daily living
    • Evaluar la seguridad y tolerabilidad del PQ912 a largo plazo
    • Evaluar la eficacia de PQ912 sobre la actividad cerebral (EEG)
    • Evaluar la eficacia de PQ912 sobre la cognición
    • Evaluar la eficacia de PQ912 en las actividades de la vida diaria
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated written informed consent obtained from the subject in accordance with local regulations.
    2. Male or female, aged > or = 50 to < or = 80 years
    3. A biomarker profile reflecting AD, according to the Alzheimer Association – National Institute on Aging (AA-NIA) Research Framework (Jenkins, Hardy, and McMurray 2002) (Jack et al. 2018) defined as follows:
    c) Screening CSF sample with an Abeta42 concentration of <1000 pg/ml AND p-tau >19 pg/ml, or a ratio of p-tau/Abeta42 of > or = 0.024 as assessed by central laboratory, (Elecsys assay), OR, in case of subjects in whom CSF sampling is not feasible due to medical or technical reasons.
    d) Existing Positive amyloid Positron-Emission Tomography (PET) evidence within six months of the screening visit.
    4. Clinical syndrome of MCI or mild dementia according to the AA-NIA Research Framework (Jack et al. 2018)
    5. A cognitive impairment in the WAIS-IV Coding Test of at least 0.5 standard deviations below the normative data
    6. Meeting the completion and performance criteria for the CogState NTB.
    7. Be in a stable therapeutic condition with respect to the current AD condition: either without specific current approved treatment (minimum wash-out period from a prior treatment is 10 weeks) and currently no plan to initiate currently approved treatment or being on an approved treatment for AD on a stable dose for at least 10 weeks.
    8. Fluency in local language and evidence of adequate intellectual functioning in the opinion of the investigator.
    9. Adequate visual and auditory abilities to perform the cognitive and functional assessments in the opinion of the investigator.
    10. Outpatient with study partner capable of accompanying the subject on all applicable clinic visits.
    11. The subject and study partner are likely to be able to participate in all scheduled evaluations according to country and site practices.
    1. Consentimiento informado por escrito firmado y fechado obtenido del sujeto de acuerdo con las normativas locales.
    2. Hombre o mujer, > o = 50 hasta < o = 80 años de edad.
    3. Un perfil de biomarcadores que refleje la EA, según el marco de investigación de la Asociación de Alzheimer - Instituto Nacional sobre el Envejecimiento (AA-NIA) (Jack et al. 2018) definido de la siguiente manera:
    a) Muestra de LCR del periodo de selección con una concentración de Abeta42 de <1000 pg/ml Y p-tau >19 pg/ml, o una proporción de p-tau/Abeta42 de > o = 0,024 según la evaluación del laboratorio central, (ensayo Elecsys) O, en caso de sujetos en los que el muestreo de LCR no es factible debido a razones médicas o técnicas:
    b) Evidencia existente de tomografía por emisión de positrones (PET) con positivo en amiloides en un plazo de seis meses antes de la visita de selección.
    4. Síndrome clínico de DCL o demencia leve según el marco de investigación de la AA-NIA (Jack et al. 2018) .
    5. Un deterioro cognitivo en la prueba de codificación WAIS-IV de al menos 0,5 desviaciones estándar por debajo de los datos normativos (consulte el Apéndice 3).
    6. Cumplir los criterios de finalización y rendimiento de la prueba CogState NTB.
    7. Estar en una condición terapéutica estable con respecto a la afección actual de la EA: ya sea sin un tratamiento específico aprobado actualmente (el período mínimo de reposo farmacológico después de un tratamiento anterior es de 10 semanas) y actualmente no está previsto iniciar el tratamiento aprobado actualmente o estar en un tratamiento aprobado para la EA con una dosis estable durante al menos 10 semanas.
    8. Fluidez en el idioma local y evidencia de un funcionamiento intelectual adecuado a juicio del investigador.
    9. Capacidades visuales y auditivas adecuadas para realizar las evaluaciones cognitivas y funcionales a juicio del investigador.
    10. Paciente ambulatorio con acompañante del estudio capaz de acompañar al sujeto en todas las visitas clínicas aplicables.
    11. Es probable que el sujeto y el acompañante de estudio puedan participar en todas las evaluaciones programadas de acuerdo con las prácticas del país y del centro.
    E.4Principal exclusion criteria
    1. Significant neurological or psychiatric disorders, other than AD, that may affect cognition.
    2. Atypical clinical presentations of MCI due to AD or mild dementia due to AD, such as visual variant of AD (including posterior cortical atrophy), frontal variant or language variant (including logopenic aphasia).
    3. Moderate and severe dementia with Mini-Mental State Examination score (MMSE) below 20.
    4. History of (maximally six months from screening) or screening visit brain MRI scan indicative of any other significant abnormality, including but not limited to severe white matter hyperintensities (Fazekas score 3), history or evidence of a single prior haemorrhage >1 cm3, multiple lacunar infarcts or evidence of single prior infarct >1 cm3, evidence of cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space-occupying lesions (e.g. brain tumours).
    5. Current presence of clinically important major psychiatric disorder (e.g. major depressive disorder) as defined by DSM-5 criteria, or symptom(s) (e.g. hallucinations) that could affect subject’s ability to complete study.
    6. Current clinically important systemic illness likely to result in clinically relevant deterioration of subject’s condition or might affect subject’s safety during study.
    7. History of clinically evident stroke.
    8. History of seizures within last two years prior to screening visit.
    9. Myocardial infarction within last six months prior to screening.
    10. History of cancer within last two years prior to screening, with exception of any of following conditions: non-metastatic basal cell carcinoma, and squamous cell carcinoma of skin. Note: subjects can be included in study with prior history of cancer if evidence of no residual disease has been clinically confirmed within last six months before baseline.
    11. History of uncontrolled hypertension (opinion of investigator) within six months prior to screening.
    12. Other clinically important diseases or conditions or abnormalities of vital signs, physical examination, neurological examination, laboratory results, or electrocardiogram (ECG) examination (e.g. atrial fibrillation) that could compromise study or safety of subject.
    13. Haemoglobin level less than 11 g/dL (6.8 mmol/L) at screening.
    14. Clinically important infection within 30 days prior to screening e.g. chronic, persistent, or acute infection, such as bronchitis or urinary tract infection.
    15. Known, untreated or insufficiently treated hypothyroidism, vitamin B12 or folate deficiency.
    16. Any known hypersensitivity to investigational product PQ912 or any of excipients.
    17. Severe hepatic failure (Child-Pugh C) or kidney failure (creatinine clearance (eGFR) < or = 30 mL/min/1.73m2) as estimated using MDRD method, or serum creatinine above 1.5-fold of Upper Limit of Normal (ULN) or Asparagine-Amino Transferase (AST) or Alanine-Amino Transferase (ALT) above 3 fold of ULN at screening.
    18. Blood donation in 90 days prior to screening.
    19. History of alcohol or drug dependence or abuse as defined by DSM-5 criteria within last two years prior to screening.
    20. Claustrophobia or presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, CSF shunts, or metal fragments or foreign objects in eyes, skin, or body that would contraindicate a brain MRI scan.
    21. Inadequate venous access to allow multiple blood draws.
    22. Personnel involved in conduct of the study.
    23. Previous participation in any investigational trial within last 60 days of screening visit
    24. Use of prohibited medications or of measures/ interventions
    o Immunosuppressive medications within last 90 days prior to baseline
    o Chemotherapeutic agents for malignancy within last year prior to baseline
    o Concomitant treatment which may impair cognitive function requires a wash out phase of at least 5 half-lives of treatment prior screening (short acting hypnotics are not permitted 72 hours before EEG or cognitive testing).
    o Anticoagulants within 30 days prior to screening and V8 (week 48)/ EOT. Combination of clopidogrel & carbasalate calcium or aspirin not allowed during time of lumbar puncture. Clopidogrel or aspirin alone is allowed.
    Strong inhibitors or inducers of CYP2C19 (washout phase of at least two weeks before baseline).
    o Substrates of CYP2C19 with narrow therapeutic margin (washout phase of at least two weeks before baseline).
    o St. John’s Wort (washout phase of at least 2 weeks prior to baseline is required).
    25. For women of childbearing potential:
    (a) Pregnancy (i.e. positive pregnancy test at Screening) or breastfeeding
    (b) Failure to agree to practice a highly effective method of contraception, from enrolment up to at least 3 months after the study end.
    26. For sexually active men with female partner of childbearing potential: failure to agree to use condom from enrolment up to at least 3 months after study end.
    1. Trastornos neurológicos o psiquiátricos importantes, distintos de la EA, que pueden afectar a la cognición.
    2. Cuadros clínicos atípicos de DCL por EA o demencia leve por EA, como la variante visual de la EA (incluida la atrofia cortical posterior), la variante frontal o la variante del lenguaje (incluida la afasia logopénica).
    3. Demencia moderada y grave con una puntuación del miniexamen del estado mental (MMSE) por debajo de 20.
    4. Antecedentes de cualquier otra anomalía significativa (como máximo seis meses antes del periodo de selección) o escáner de RM cerebral en la visita de selección indicativo de cualquier otra anomalía significativa, incluidas, entre otras, hiperintensidades graves de la materia blanca (puntuación de Fazekas 3), antecedentes o evidencia de una única hemorragia previa >1 cm3, múltiples infartos lacunares o evidencia de un único infarto previo >1 cm3, evidencia de contusión cerebral, encefalomalacia, aneurismas, malformaciones vasculares, hematoma subdural o lesiones que ocupan espacio (p. ej., tumores cerebrales).
    5. Presencia actual de un trastorno psiquiátrico mayor clínicamente importante según lo definido por los criterios del DSM-5, o síntoma(s) (p. ej., alucinaciones) que puedan afectar la capacidad del sujeto para completar el estudio.
    6. Enfermedad sistémica clínicamente importante actual que es probable que produzca un deterioro clínicamente relevante de la afección del sujeto o que pueda afectar a la seguridad del sujeto durante el estudio.
    7. Antecedentes de accidente cerebrovascular clínicamente evidente.
    8. Antecedentes de convulsiones en los últimos dos años antes de la visita de selección.
    9. Infarto de miocardio en los últimos seis meses antes de la selección.
    10. Antecedentes de cáncer en los últimos dos años antes de la selección, con la excepción de cualquiera de las siguientes afecciones: carcinoma de células basales no metastásico y carcinoma epidermoide.
    11. Antecedentes de hipertensión no controlada (en opinión del investigador) en los seis meses anteriores a la selección.
    12. Otras enfermedades o afecciones clínicamente importantes o anomalías de las constantes vitales, examen físico, examen neurológico, resultados de los análisis o ECG
    (p. ej., fibrilación auricular) que puedan afectar al estudio o a la seguridad del sujeto.
    13. Nivel de hemoglobina inferior a 11 g/dl (6,8 mmol/l) en la selección.
    14. Infección clínicamente importante en los 30 días anteriores a la selección, p. ej., infección crónica, persistente o aguda, como bronquitis o infección del tracto urinario.
    15. Hipotiroidismo diagnosticado, no tratado o insuficientemente tratado, deficiencia de vitamina B12 o folato.
    16. Cualquier hipersensibilidad conocida al producto en fase de investigación PQ912 o a cualquiera de sus excipientes (sección 6.2 del protocolo del estudio).
    17. Insuficiencia hepática grave (Child-Pugh C) o insuficiencia renal (aclaramiento de creatinina < o = 30 ml/min/1,73 m 2 ) según lo estimado mediante el método MDRD, o creatinina sérica superior a 1,5 veces el LS) o AST o ALT superior a 3 veces el LSN en la selección.
    18. Donación de sangre en los 90 días previos a la selección.
    19. Antecedentes de dependencia o consumo de alcohol o drogas según lo definido por los criterios del DSM-5 en los últimos dos años antes de la selección.
    20. Claustrofobia o presencia de marcapasos, pinzas ("clips") metálicas para aneurismas, válvulas cardiacas artificiales, implantes de oído, derivaciones de LCR o fragmentos de metal u objetos extraños en los ojos, la piel o el cuerpo que contraindiquen un escáner de RM cerebral.
    21. Acceso venoso inadecuado para permitir múltiples extracciones de sangre.
    22. Personal que participa en la realización del estudio: sujetos que son miembros del personal del centro de investigación involucrados directamente en la realización del ensayo y sus familiares, miembros del personal del centro supervisados por el Investigador o sujetos que son empleados de Vivoryon involucrados directamente en la realización del ensayo.
    23. Participación previa en cualquier ensayo de investigación en los últimos 60 días antes de la visita de selección.
    24. Uso de medicamentos prohibidos o de medidas/intervenciones según protocolo

    25. Para mujeres en edad fértil:
    (a) Embarazo (es decir, prueba de embarazo positiva en la selección) o lactancia.
    (b) No aceptar la práctica de un método anticonceptivo altamente eficaz, desde la inclusión hasta al menos 3 meses después de la finalización del estudio.
    26. Para hombres sexualmente activos con una pareja femenina en edad fértil: No aceptar el uso del condón desde la inscripción hasta al menos 3 meses después de la finalización del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    • all spontaneously reported AEs, vital signs (heart rate and blood pressure), clinical laboratory tests, physical and neurological examinations.
    • ECG measurements and changes on brain MRI scans as judged by the investigational site rater (Amyloid-related Imaging Abnormalities – Edema/Effusion [ARIA-E], Amyloid-related Imaging Abnormalities – Haemorrhage/Haemosiderin deposition [ARIA-H], infarcts).
    • Linear change with time on working memory and attention as measured by the combined Z-score of the Detection test, Identification test and the ‘One Back’ test (attention and working memory domains) of the NTB.
    • todos los AA comunicados espontáneamente, las constantes vitales (frecuencia cardíaca y presión arterial), las pruebas de laboratorio clínico y los exámenes físicos y neurológicos.
    • Las mediciones del ECG y los cambios en las resonancias magnéticas cerebrales, según el criterio del evaluador del centro de investigación (Anomalías de imagen relacionadas con el amiloide - Edema/Efusión [ARIA-E], Anomalías de imagen relacionadas con el amiloide - Hemorragia/Depósito de hemosiderina [ARIA-H], infartos).
    • Cambio lineal con el tiempo en la memoria de trabajo y la atención, medido por la puntuación Z combinada de la prueba de detección, la prueba de identificación y la prueba "One Back" (dominios de atención y memoria de trabajo) del NTB.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Treatment visit (week 48, 60, 72, 84 or 96 weeks of treatment, depending on time of randomization.)
    Visita de fin de tratamiento (semanas 48, 60, 72, 84 o 96 de tratamiento, según el momento de la aleatorización).
    E.5.2Secondary end point(s)
    • Change from baseline in global relative theta power in the EEG (4-8 Hz) at week 48 power.
    • Linear change with time in overall cognition as measured by the CBB Z-score
    • Linear change with time of overall cognition as measured by the composite Z-score of the complete NTB
    • Change from baseline in daily activities as measured by A-IADL-Q total score at Week 48 and EOT
    • Cambio con respecto al valor inicial en la potencia global relativa theta (4-8 Hz) en el EEG en la semana 48
    • Cambio lineal con el tiempo en la cognición general registrado mediante la prueba CBB (puntuación Z)
    • Cambio lineal con el tiempo en la cognición general registrado mediante la puntuación Z compuesta de la prueba NTB completa
    • Cambio con respecto al valor inicial en las actividades diarias registrado mediante la puntuación total de A-IADL-Q en la semana 48 y el FDT
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 48 and End of Treament (i.e. week 60, 72, 84 or 96 weeks of treatment, depending on time of randomization.)
    Semana 48 y fin del tratamiento (es decir, semana 60, 72, 84 o 96 de tratamiento, según el momento de la aleatorización).
    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 No
    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. 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 concerned5
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Última visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months33
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months38
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 215
    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 state62
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    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)
    Standard of care treatment
    Tratamiento estándard
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-04
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands