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    Summary
    EudraCT Number:2017-004335-36
    Sponsor's Protocol Code Number:ANAVEX2-73-PDD-001
    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:2018-04-11
    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 number2017-004335-36
    A.3Full title of the trial
    A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Parkinson’s Disease with Dementia Patients.
    Estudio de fase II, doble ciego, aleatorizado y controlado con placebo para evaluar la seguridad, la tolerabilidad y la eficacia de ANAVEX2-73 en relación con el deterioro cognitivo en pacientes con enfermedad de Parkinson y demencia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Parkinson’s Disease with Dementia Patients.
    Estudio de fase II, doble ciego, aleatorizado y controlado con placebo para evaluar la seguridad, la tolerabilidad y la eficacia de ANAVEX2-73 en relación con el deterioro cognitivo en pacientes con enfermedad de Parkinson y demencia.
    A.3.2Name or abbreviated title of the trial where available
    A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73
    Estudio de fase II para evaluar la seguridad, la tolerabilidad y la eficacia de ANAVEX2-73
    A.4.1Sponsor's protocol code numberANAVEX2-73-PDD-001
    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 SponsorAnavex Life Sciences Corp.
    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 supportAnavex Life Sciences Corp.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeon Research S.L.
    B.5.2Functional name of contact pointIrene Mínguez Ardura
    B.5.3 Address:
    B.5.3.1Street AddressAvd. Ordoño II, 37 - 2º Dcha.
    B.5.3.2Town/ cityLeon
    B.5.3.3Post code24001
    B.5.3.4CountrySpain
    B.5.4Telephone number0034987261 064
    B.5.5Fax number0034987216 243
    B.5.6E-mailiminguez@leonresearch.es
    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 nameANAVEX2-73
    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 INNANAVEX2-73
    D.3.9.2Current sponsor codeANAVEX2-73
    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.3.1Product nameANAVEX2-73
    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 INNANAVEX2-73
    D.3.9.2Current sponsor codeANAVEX2-73
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the 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
    Cognition in Parkinson’s Disease with dementia
    Deterioro cognitivo en enfermedad de Parkinson con demencia
    E.1.1.1Medical condition in easily understood language
    Cognition in Parkinson’s Disease with dementia
    Deterioro cognitivo en enfermedad de Parkinson con demencia
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    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 ANAVEX2-73 compared to placebo. To
    assess the efficacy of ANAVEX2-73 in cognition compared to placebo.
    Evaluar la seguridad y tolerabilidad de ANAVEX2-73 comparado con placebo.
    Evaluar la eficacia de ANAVEX2-73 sobre la cognición en comparación con el
    placebo.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of ANAVEX2-73 in reducing Parkinsonian motor
    symptoms in PDD patients compared to placebo.
    Evaluar la eficacia de ANAVEX2-73 para reducir los síntomas motores de
    Parkinson en pacientes con DEP en comparación con placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of idiopathic Parkinson’s disease (PD) consistent with the UK Parkinson’s Disease Society Brain Bank diagnostic criteria.
    2. Diagnosis of probable PD dementia (PDD) according to the Movement Disorder Society Task Force clinical diagnostic criteria.
    3. Montreal Cognitive Assessment (MoCA) score of 13 to 23, inclusive, at Screening.
    4. Male or female and aged ≥ 50 years.
    5. Caregivers and subjects (or legal representative) must understand and have signed approved informed consent.
    6. Caregivers and subjects (or legal representative) must be able to understand study requirements and be willing to follow instructions.
    7. Stable regimen of anti-Parkinson’s disease medications (including levodopa, dopamine agonists, MAO-B inhibitors, or the COMT inhibitor entacapone), which has been stable for at least 4 weeks prior to Baseline.
    8. Treatment with cholinesterase inhibitor (rivastigmine, donepezil and galantamine (Exelon®, Aricept®, or Reminyl®) will be permitted, provided the dose has been stable for a minimum of 8 weeks prior to randomization.
    9. Subjects with history of depression on antidepressant medications will be allowed if depression is controlled and they have been on a stable daily dose of the antidepressant for ≥8 weeks before Baseline.
    10. Contraception:
    o Women of childbearing potential must use an acceptable method of contraception starting 4 weeks prior to study drug administration and for a minimum of 4 weeks after study completion. Otherwise, women must be postmenopausal (at least one year absence of vaginal bleeding or spotting) as confirmed by FSH greater than or equal to 40 mIU/mL or 40 IU/L or be surgically sterile.
    o Men with a potentially fertile partner must have had a vasectomy or be willing to use an acceptable method of contraception for the duration of the study and for 3 months after study drug discontinuation.
    Note: For men and women, acceptable methods of contraception include use of a condom with spermicide or use of oral, implantable or injectable contraceptives, or IUD, or a diaphragm with spermicide or diaphragm with condom.
    1. Diagnóstico de enfermedad de Parkinson (EP) idiopática compatible con los criterios de diagnóstico de la Parkinson’s Disease Society Brain Bank del Reino Unido.
    2. Diagnóstico de probable demencia por EP (DEP) según los criterios de diagnóstico clínico del Movement Disorder Society Task Forces.
    3. Puntuación de 13 a 23 en la evaluación cognitiva de Montreal (MoCA), también en la selección.
    4. Varón o mujer de 50 años o más.
    5. Tanto el cuidador (o un representante legal) como el paciente deben entender y firmar un documento de consentimiento informado.
    6. El cuidador (o un representante legal) y el paciente deben entender los requisitos del estudio y estar dispuestos a seguir las instrucciones que reciban.
    7. Pauta estable de medicación contra el Parkinson (incluidos levodopa, agonistas de la dopamina, inhibidores de MAO-B o inhibidor de COMT entacapona) que se haya mantenido estable durante al menos las 4 semanas previas al momento basal.
    8. Se permitirá el tratamiento con inhibidores de la colinesterasa (rivastigmina, donepezilo y galantamina (Exelon®, Aricept® o Reminyl®), siempre que la dosis se haya mantenido estable durante al menos las 8 semanas previas a la aleatorización.
    9. Los sujetos con antecedentes de depresión o tratamiento con antidepresivos podrán participar si la depresión está controlada y si se han mantenido con una dosis diaria estable de antidepresivos durante al menos las 8 semanas previas al momento basal.
    10. Anticoncepción:
    o Las mujeres capaces de concebir deben utilizar un método anticonceptivo aceptable instaurado 4 semanas antes del inicio de la administración del fármaco del estudio y mantenido durante al menos 4 semanas después de la terminación del estudio. Las mujeres pueden también ser postmenopáusicas (ausencia de hemorragia o manchado
    vaginal desde hace al menos un año), estado confirmado por un valor de FSH de al menos 40 mUI/ml o 40 UI/l, o estar esterilizadas quirúrgicamente.
    o Los varones con una pareja potencialmente fértil deben estar vasectomizados o estas dispuestos a utilizar un método anticonceptivo aceptable durante todo el estudio y durante los 3 meses siguientes al final de la administración del fármaco del estudio.
    Nota: Para varones y mujeres, son métodos anticonceptivos aceptables el preservativo con espermicida, los anticonceptivos orales, implantables o inyectables, el DIU, un diafragma con espermicida o un diafragma con preservativo.
    E.4Principal exclusion criteria
    1. History of any significant neurologic or psychiatric disorder other than PD that can contribute to cognitive impairment.
    2. Any other condition or clinically significant abnormal findings like severe co-morbidities e.g. history of stroke, poor kidney or liver function on the physical or neurological examination, medical and psychiatric history, at screening or at baseline that, in the opinion of the Investigator, would make the subject unsuitable for the study.
    3. Potential symptomatic causes of cognitive impairment including but not limited to
    a. abnormal thyroid function test at screening (TSH)
    b. abnormal B12 level at screening
    c. MRI findings (by history) pointing to a potential symptomatic cause of cognitive dysfunction, including significant vascular changes, or communicating hydrocephalus.
    4. Treatment with memantine or amantadine. If appropriate the drugs can be discontinued for a minimum of 4 weeks prior to randomization.
    5. Use of over the counter (OTC) or prescription medication for sleep on 2 or more occasions per week (less than that is allowed).
    6. History of depression as measured by Beck Depression Inventory score >17 at screening.
    7. Treatment with any other investigational drug or device within 4 weeks prior to screening.
    8. Smoking > 1 pack of cigarettes per day (as assessed for the 4 weeks prior to screening).
    9. Women who are pregnant or lactating.
    10. Known allergy or sensitivity to ANAVEX2-73 or any of its components.
    11. Suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) of type 4 or type 5, or any suicidal behavior, in the past 6 months. Type 4 indicates active suicidal ideation with some intent to act, without a specific plan. Type 5 indicates active suicidal ideation with a specific plan and intent.
    12. Use of centrally acting anticholinergic drugs during the 4 weeks before randomization.
    a. Medications used for overactive bladder will be allowed provided that the regimen has been stable 4 weeks prior to randomization.
    13. Treatment with any dopamine receptor blocking medications with the exception of low dose quetiapine (≤50 mg/day). Pimavanserin (≤34 mg/day) will be allowed.
    14. History of neurosurgical intervention (e.g., deep brain stimulation) for PD.
    15. Unpredictable motor fluctuations that would interfere with administering cognitive assessments in the ON state.
    1. Antecedentes de trastornos neurológicos o psiquiátricos de importancia distintos de la EP que puedan contribuir al deterioro cognitivo.
    2. Otras afecciones o anomalías de importancia clínica como graves comorbilidades, p.ej. historial de accidente cerebrovascular, insuficiencia renal o hepática detectadas en el examen físico o neurológico, la historia médica y psiquiátrica, en la selección o en el momento basal que, a juicio del investigador, puedan hacer que el sujeto sea inadecuado para el estudio.
    3. Posibles causas sintomáticas de deterioro cognitivo, entre otras:
    a. resultado anómalo en la prueba de la función tiroidea de selección (TSH)
    b. concentración anormal de B12 en la selección
    c. observaciones mediante RM (en el historial) que sugieran una posible causa sintomática de la disfunción cognitiva, como excesivas alteraciones vasculares o hidrocefalia comunicante
    4. Tratamiento con memantina o amantadina si los medicamentos apropiados pueden retirarse durante al menos las 4 semanas previas a la aleatorización.
    5. Uso de medicamentos para dormir, con o sin receta (OTC), 2 o más veces por semana (una frecuencia menor es permitida).
    6. Antecedentes de depresión indicada por una puntuación superior a 17 en el Inventario Beck de depresión en la selección.
    7. Tratamiento con otro fármaco o producto sanitario en investigación durante las 4 semanas previas a la selección.
    8. Fumar > 1 paquete de cigarrillos por día (según las evaluaciones de las 4 semanas anteriores a la selección).
    9. Mujeres gestantes o lactantes.
    10. Alergia o sensibilidad documentadas a ANAVEX2-73 o a cualquiera de sus componentes.
    11. Ideación suicida de tipo 4 o 5 según la escala Columbia Suicide Severity Rating Scale (C-SSRS) o cualquier comportamiento suicida durante los últimos seis meses. El tipo 4 indica ideas activas de suicidio con algún intento, pero sin un plan concreto. El tipo 5 indica ideas activas de suicidio con un plan concreto intentado.
    12. Uso de medicamentos anticolinérgicos de acción central durante las 4 semanas previas a la aleatorización.
    a. Se permiten los medicamentos utilizados para tratar la vejiga hiperactiva si la pauta se ha mantenido estable durante las 4 semanas previas a la aleatorización.
    13. Tratamiento con cualquier medicamento bloqueante de los receptores de dopamina, salvo la quetiapina a dosis bajas (≤50 mg/día). Se permitirá la pimavanserina (≤34 mg/día).
    14. Antecedentes de intervenciones neuroquirúrgicas (por ejemplo, estimulación cerebral profunda) para el tratamiento de la EP.
    15. Fluctuaciones motrices impredecibles que puedan interferir con la administración de las evaluaciones cognitivas en el estado «on».
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint: Change from Baseline to End of Treatment in Continuity of Attention as measured by Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention test.
    Primary safety endpoint: Tolerability as determined by the number of subjects completing the study on active treatment versus placebo and proportion of subjects completing the study.
    Criterio de valoración primario de eficacia: cambio desde el inicio hasta el final del tratamiento en la continuidad de la atención, según la medida del Cognitive Drug Research (CDR), sistema de evaluación computarizado de la prueba de continuidad de atención
    Criterio de valoración primario de seguridad: Tolerabilidad, determinada por el número de sujetos que completan el estudio con tratamiento activo en comparación con placebo y por la proporción de sujetos que completan el estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary efficacy endpoint: Change from Baseline to End of Treatment in Continuity of Attention as measured by Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention test.
    Primary safety endpoint: Tolerability as determined by the number of subjects completing the study on active treatment versus placebo and proportion of subjects completing the study.
    Criterio de valoración primario de eficacia: cambio desde el inicio hasta el final del tratamiento en la continuidad de la atención, según la medida del Cognitive Drug Research (CDR), sistema de evaluación computarizado de la prueba de continuidad de atención
    Criterio de valoración primario de seguridad: Tolerabilidad, determinada por el número de sujetos que completan el estudio con tratamiento activo en comparación con placebo y por la proporción de sujetos que completan el estudio.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints: Change from Baseline to End of Treatment in Power of Attention as measured by CDR Power of Attention test and Change from baseline to End of Treatment as measured by MDS-UPDRS Part III Total Score (Motor Scores).
    Criterio de valoración secundario de eficacia: cambio desde el inicio hasta el final del tratamiento en la capacidad de atención medido por la prueba de capacidad de atención CDR y el cambio desde el inicio hasta el final del tratamiento según la medida de puntuación total de la Parte III del MDS-UPDRS (puntuaciones motoras).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy endpoints: Change from Baseline to End of Treatment in Power of Attention as measured by CDR Power of Attention test and Change from baseline to End of Treatment as measured by MDS-UPDRS Part III Total Score (Motor Scores).
    Criterio de valoración secundario de eficacia: cambio desde el inicio hasta el final del tratamiento en la capacidad de atención medido por la prueba de capacidad de atención CDR y el cambio desde el inicio hasta el final del tratamiento según la medida de puntuación total de la Parte III del MDS-UPDRS (puntuaciones motoras).
    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 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 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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned20
    E.8.5The trial involves multiple Member States No
    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 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 último paciente
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months5
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.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 Decision2018-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
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