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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   39229   clinical trials with a EudraCT protocol, of which   6426   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).
     
    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

    Summary
    EudraCT Number:2018-002140-88
    Sponsor's Protocol Code Number:CL04-ORY-2001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-07-25
    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 number2018-002140-88
    A.3Full title of the trial
    An unicenter, open-label, 1-arm, 8-week study to evaluate the efficacy, safety and tolerability of ORY-2001 in aggression in adult population with Alzheimer’s Disease (AD), Lewy Body Dementia (LBD), Adult attention Deficit Hyperactivity Disorder (ADHD) Borderline Personality Disorder (BPD), Autism Spectrum Disorder (ASD)
    Ensayo unicéntrico, abierto, con 1 brazo, de 8 semanas de duración para evaluar
    la eficacia, seguridad y tolerancia de ORY-2001 en agresividad en población adulta con
    Enfermedad de Alzheimer, Demencia de Cuerpos de Lewy, Trastorno por Déficit de
    Atención e Hiperactividad, Trastorno Límite de la Personalidad y Trastorno del Espectro
    Autista.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety, tolerability and efficacy of ORY-2001 in aggression
    in patients with Alzheimer's Disease, Lewy Body Dementia, Adult attention Deficit Hyperactivity Disorder, Borderline Personality Disorder, Autism Spectrum Disorder
    Estudio para evaluar la seguridad, tolerabilidad y eficacia de ORY-2001 en el tratamiento de la agresividad en pacientes con Enfermedad de Alzheimer, Demencia de Cuerpos de Lewy, Trastorno por Déficit de Atención e Hiperactividad, Trastorno Límite de la Personalidad y Trastorno del Espectro Autista.
    A.3.2Name or abbreviated title of the trial where available
    REIMAGINE
    REIMAGINE
    A.4.1Sponsor's protocol code numberCL04-ORY-2001
    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 SponsorOryzon Genomics S.A.
    B.1.3.4CountrySpain
    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 supportOryzon Genomics S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOryzon Genomics S.A.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressSant Ferran 74
    B.5.3.2Town/ cityCornellà de Llobregat, Barcelona
    B.5.3.3Post code08940
    B.5.3.4CountrySpain
    B.5.4Telephone number3467 1048676
    B.5.6E-maildgualteros@oryzon.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameORY-2001
    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 INNORY-2001
    D.3.9.2Current sponsor codeORY-2001
    D.3.9.3Other descriptive namePHENYLCYCLOPROPYLAMINE DERIVATIVES AND DUAL LSD1/MAO-B (LYSINE-SPECIFIC DEMETHYLASE 1 AND MONOAMINE OXIDASE-B) INHIBITOR
    D.3.9.4EV Substance CodeSUB179357
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Agression
    Agresividad
    E.1.1.1Medical condition in easily understood language
    Agression
    Agresividad
    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 PT
    E.1.2Classification code 10001488
    E.1.2Term Aggression
    E.1.2System Organ Class 10037175 - Psychiatric 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 safety and tolerability of ORY-2001 in adult population with Alzheimer’s Disease (AD), Lewy Body Dementia (LBD), Adult attention deficit hyperactivity disorder (ADHD), Borderline Personality Disorder (BPD), Autism Spectrum Disorder (ASD)
    Evaluar la seguridad y tolerabilidad de ORY-2001 en población adulta con Enfermedad de Alzheimer, Demencia de Cuerpos de Lewy, Trastorno por Déficit de Atención e Hiperactividad, Trastorno Límite de la Personalidad y Trastorno del Espectro Autista
    E.2.2Secondary objectives of the trial
    To investigate the efficacy of ORY-2001 in aggression in adult population with Alzheimer’s Disease (AD), Lewy Body Dementia (LBD), Adult attention deficit hyperactivity disorder (ADHD), Borderline Personality Disorder (BPD), Autism Spectrum Disorder (ASD)
    Evaluar la eficacia de ORY-2001 en agresividad en población adulta con Enfermedad de Alzheimer, Demencia de Cuerpos de Lewy, Trastorno por Déficit de Atención e Hiperactividad, Trastorno Límite de la Personalidad y Trastorno del Espectro Autista
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women 18-85 years of age.
    2. Body mass index (BMI) of at least 18.5 kg/m2.
    3. Significant or persistent agitation or aggression that was disruptive to patient’s daily living or put the patient in harm´s way for at least 3 days per week for at least 4 weeks prior to screening visit.
    4. MMSE score at Screening and Baseline Visits not greater than 16 but able to consent (only applicable to AD and LBD patients).
    5. Outpatient consulting a general practitioner, or a psychiatrist/neurologist/geriatrician.
    6. A current diagnosis for AD, LBD, ADHD, BPD or ASD according to DSM-5 criteria.
    7. Knowledgeable and reliable close relative/caregiver who will accompany the patient to all clinic visits during the study (for all AD and for LBD, ASD patients as necessary based on the criteria of the clinician).
    8. Stable pharmacological treatment as per SmPC of AD, LBD, ADHD, BPD or ASD for at least four months (with the same dose for at least two months) prior to screening – including anti-inflammatories.
    9. Fertile male and female must use highly efficient contraception, from the Screening Visit until 30 days after last dose of the IMP, defined as:
    i. A method with less than 1% failure rate (e.g. permanent sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomised partner)
    OR
    ii. The use of two methods of contraception (e.g. one barrier method [condom, diaphragm or cervical/vault caps] with spermicide and one hormonal contraceptive [e.g. combined oral contraceptives, patch, vaginal ring, injectable and implants])
    10. Signed informed consent by patient (or legal representative, if applicable) and a close relative/caregiver prior to the initiation of any study specific procedure.
    1. Hombres y mujeres de 18 a 85 años
    2. Índice de masa corporal (IMC) de al menos 18,5 kg/m2
    3. Agitación o agresividad significativa o persistente, perturbadora de la rutina diaria del paciente o que lo ponga en peligro al menos 3 veces por semana durante al menos 4 semanas antes de la visita de selección
    4. Puntuación del MMSE en las visitas de selección y basal no superior a 16 pero con capacidad de otorgar consentimiento (aplicable solamente a pacientes con Enfermedad de Alzheimer o Demencia de Cuerpos de Lewy)
    5. Paciente de consulta ambulatoria a un médico general, o un psiquiatra/neurólogo/geriatra
    6. Diagnóstico de Enfermedad de Alzheimer, Demencia de Cuerpos de Lewy, Trastorno por Déficit de Atención e Hiperactividad, Trastorno Límite de la Personalidad o Trastorno del Espectro Autista acorde al criterio DSM-5
    7. Contar con un familiar/cuidador cercano y fiable que acompañe al pacientea todas las visitas al centro durante el estudio (aplicable a todos los pacientes con Enfermedad de Alzheimer o Demencia de cuerpos de Lewy, y en aquellos con Trastorno del Esectro Autista según criterio clínico)
    8. Tratamiento farmacológico estable acorde al Resumen de Características del Producto (SmPC, siglas en inglés) para Enfermedad de Alzheimer, Demencia de Cuerpos de Lewy, Trastorno por Déficit de Atención e Hiperactividad, Trastorno Límite de la Personalidad y Trastorno del Espectro Autista durante al menos 4 meses (con la misma dosis durante los 2 últimos meses) previos a la visita de selección, incluídos los antiinflamatorios.
    9. Los hombres y mujeres fértiles deben usar métodos anticonceptivos altamente eficaces, desde la visita de selección hasta 30 días después de la última dosis del MI, definida como:
    a. Un método con una tasa de no funcionamiento inferior al 1% (por ejemplo, esterilización permanente, implantes de hormonas, inyecciones de hormonas, algunos dispositivos intrauterinos o pareja con vasectomía)
    ó
    b. El uso de dos métodos de anticoncepción (por ejemplo, un método de barrera [condón, diafragma o cápsulas cervicales/bóveda] con espermicida y un anticonceptivo hormonal [por ejemplo, anticonceptivos orales combinados, parche, anillo vaginal, inyectables e implantes])
    10. Consentimiento informado firmado por el paciente (o el representante legal, si procede) y un familiar/cuidador cercano antes de iniciar cualquier procedimiento específico del estudio
    E.4Principal exclusion criteria
    1. Failure to perform screening or baseline examinations.
    2. Hospitalization or change of concomitant medication two months prior to Screening visit or during Screening Period.
    3. Member or immediate family of the study personnel or subordinate (or immediate family of a subordinate) to any of the study personnel.
    4. Patient under forced treatment.
    5. Positive results for human immunodeficiency virus (HIV), hepatitis C or hepatitis B (hepatitis B surface antigen [HbsAg]) serology at the Screening Visit, or significant medical history, signs and symptoms for tuberculosis (TB) according to the investigator criteria.
    6. Clinically significant, advanced or unstable disease that may interfere with evaluation:
    a. Seizures disorders
    b. Respiratory insufficiency (partial pressure of oxygen <60 mm Hg and partial pressure of carbon dioxide <50 mmHg)
    c. Hepatic impairment (serum total bilirubin value, serum alanine aminotransferase [ALT], serum aspartate aminotransferase [AST] and gamma-glutamyltransferase [GGT] 1.5 x upper limit of normal [ULN])
    d. Renal insufficiency (serum creatinine >2mg/dl)
    e. Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within 6 months before Screening Visit)
    f. Hypertension treatment with more than 2 drugs
    g. Atrioventricular block (type II / Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcB-interval (males >450 msec and females >470 msec)
    h. Uncontrolled diabetes (Hb1Ac >7.5)
    i. Haematological disorders, especially thrombocytopenia (platelets <75 000/mm3) and neutropenia (neutrophils <1 500/mm3)
    j. Malignant tumours within the last 5 years
    7. Disability that may prevent the patients from completing all study requirements; for instance, blindness, deafness, severe language difficulty
    8. Chronic drug intake of:
    a. Acenocoumarol, warfarin or digitoxin
    b. Antidepressants (other than selective serotonin reuptake inhibitors [SSRIs] or selective serotonin–norepinephrine reuptake inhibitors [SSNRIs]), antipsychotics (other than atypical antipsychotics), mood stabilizers (i.e. lithium or valproic acid). Note: Patients may be included if treated with a stable dose of SSRIs, SSNRIs, bupropion as antidepressants, benzodiazepines, zolpidem, or atypical antipsychotics, for at least four months before Screening Visit.
    c. Systemic anticholinergics
    d. Nootropics; for instance, racetams, anphetamines, metylphenidate, levodopa, atomoxetina, preparations containing Gingko biloba or St John′s Wort
    e. Centrally active anti-hypertensive drugs (such as clonidine, a-methyldopa, guanidine, guanfacine)
    f. Corticosteroids or immunosuppressant (only inhaled or topical suspension are allowed).
    g. MAO inhibitors
    h. No regular intake of medications acting directly on central nervous system that investigator consider relevant to the study.
    9. Suspected or known drug or alcohol abuse.
    10. Enrolment in another investigational study or intake of investigational drug within the previous 3 months.
    11. Suicide attempt within the last year or significant risk of suicide (in the opinion of the investigator, defined as a “yes” to suicidal ideation questions 4 or 5, or answering “yes” to suicidal behavior on the Columbia-Suicide Severity Rating Scale within the past 12 months)
    12. Any condition that in the opinion of the investigator makes the patient unsuitable for inclusion in the study
    1. Incumplir las exploraciones de la visita de selección o basal
    2. Hospitalización o cambio de la medicación concomitante 1 mes antes de la visita de selección o durante el período de selección
    3. Miembro o familia inmediata del personal de estudio o subordinado (o familia inmediata de un subordinado) a cualquiera de los miembros del personal de estudio
    4. Paciente bajo tratamiento forzado
    5. Resultados positivos para el virus de la inmunodeficiencia humana (VIH), hepatitis C o hepatitis B (antígeno de superficie de la hepatitis B [HbsAg]) en la visita de selección, o antecedentes en la historia clínica, signos y síntomas para tuberculosis (TB) de acuerdo con el criterio del investigador
    6. Enfermedad clínicamente significativa, avanzada o inestable que
    puede interferir en la evaluación:
    a. Trastornos convulsivos
    b. Insuficiencia respiratoria (presión parcial de oxígeno <60 mmHg y
    presión parcial de dióxido de carbono >50 mmHg)
    c. Alteración hepática (valor de bilirrubina total en suero, alanina
    aminotransferasa [ALT] sérica, aspartato aminotransferasa [AST] sérica
    y gamma-glutamiltransferasa [GGT] 1,5 x límite superior de la
    normalidad [LSN])
    d. Insuficiencia renal (creatinina sérica >2 mg/dl)
    e. Cardiopatía (infarto de miocardio, angina inestable, insuficiencia
    cardíaca, miocardiopatía en los 6 meses anteriores a la visita de
    selección)
    f. Tratamiento de la hipertensión con más de 2 fármacos
    g. Bloqueo auriculoventricular (tipo II/Mobitz II y tipo III), síndrome
    de QT largo congénito, disfunción del nódulo sinusal o prolongación del
    intervalo QTcB (hombres >450 ms y mujeres >470 ms)
    h. Diabetes no controlada Hb1Ac >7,5
    i. Trastornos hematológicos, especialmente trombocitopenia (plaquetas
    <75000/mm3) y neutropenia (neutrófilos <1500/mm3)
    j. Tumores malignos en los últimos 5 años
    7. Discapacidad que puede impedir que los pacientes cumplan todos los
    requisitos del estudio; por ejemplo, ceguera, sordera, dificultad grave en
    el lenguaje
    8. Administración crónica de:
    a. Acenocumarol, warfarina o digitoxina
    b. Antidepresivos (que no sean inhibidores selectivos de la recaptación
    de serotonina [ISRS] o inhibidores selectivos de la recaptación de
    serotonina-norepinefrina [ISRSN]), antipsicóticos (que no sean antipsicóticos atípicos), estqabilizadores del estado de ánimo (por ejemplo, litio o ácido valproico). Not: Los pacientes pueden incluirse si reciben tratamiento con una dosis estable de antidepresivos ISRS o ISRSN, bupropion como antidepresivo, benzodiazepinas, zolpidem o antipsicóticos atípicos durante al menos cuatro meses antes de la visita de selección.
    c. Anticolinérgicos sistémicos
    d. Nootrópicos; por ejemplo, racetams, anfetaminas, metilfenidato,
    levodopa, atomoxetina, preparaciones que contienen Gingko biloba o
    hipérico
    e. Fármacos antihipertensores activos a nivel central (como clonidina,
    a-metildopa, guanidina, guanfacina)
    f. Corticoesteroides o inmunosupresores (de administración inhalada o tópica están permitidos)
    g. Inhibidores de la MAO
    h. La administración no habitual de medicamentos que actúan
    directamente en el sistema nervioso central que el investigador
    considere relevante para el estudio
    9. Sospecha o conocimiento de abuso de drogas o alcohol
    10. Inclusión en otro estudio de investigación o toma de fármacos en
    investigación en los 3 meses anteriores
    11. Intento de suicidio durante el último año o riesgo significativo de
    suicidio (en opinión del investigador, definido como un "sí" a las
    preguntas 4 o 5 de la ideación suicida o responder "sí" al
    comportamiento suicida en la escala Columbia de gravedad del suicidio en los anteriores 12 meses).
    12. Cualquier condición que, en opinión del investigador, haga que el
    paciente no sea apto para su inclusión en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints – Safety

    • Number, frequency and severity of Treatment Emergent Adverse Events (TEAEs) up to Week 8.
    • Number, frequency and severity of Serious TEAEs up to Week 8.
    • Number and percentage of withdrawn patients due to TEAEs up to Week 8.
    • Change from baseline to Week 8 in physical examination, vital signs and ECG parameters.
    • Frequency of physical examination parameters, vital signs and ECG parameters of potential clinical concern throughout the study period.
    • Change from baseline to Week 8 in clinical laboratory parameters (hematology, including platelets) and clinical chemistry.
    • Frequency of clinical laboratory parameters (hematology, including platelets, and clinical chemistry) of potential clinical concern throughout the study period.
    • Use of concomitant medication throughout the study period
    Seguridad

    • Número, frecuencia e intensidad de los acontecimientos adversos (AA) surgidos hasta la semana 8
    • Número, frecuencia e intensidad de los acontecimientos adversos graves surgidos hasta la semana 8
    • Número y porcentaje de pacientes retirados por AA hasta la semana 8
    • Cambio desde basal hasta la semana 8 en la exploración física, las constantes vitales y los parámetros de ECG
    • Frecuencia de los parámetros analíticos clínicos (hematología, incluidas las plaquetas y bioquímica clínica) de importancia clínica potencial a lo largo del estudio
    • Uso de medicación concomitante a lo largo del estudio
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 week
    8 semanas
    E.5.2Secondary end point(s)
    Secondary Endpoints– Efficacy

    • Change from Baseline to Week 8 in the Neuropsychiatric Inventory Questionnaire (NPI)
    • Change over time in the NPI
    • Change from Baseline to Week 8 in the CGI-A
    • Change over time in the CGI-A
    • Change from Baseline to Week 8 in the Mini-Mental State Examination (MMSE) for AD and LBD patients
    • Change over time compared in the MMSE for AD and LBD patients
    • Change from Baseline to Week 8 in the ADHD-RS for ADHD patients
    • Change over time in the ADHD-RS for ADHD patients
    • Change from Baseline to Week 8 in the Autism Diagnostic Observation Schedule (ADOS) for ASD patients
    • Change over time in the ADOS for ASD patients
    • Change from Baseline to Week 8 in the Borderline Personality Disease Checklist (BPDCL) for BPD patients
    • Change over time in the BPDCL for BPD patients
    Eficacia

    - Cambio desde basal hasta la semana 8 en la NPI
    - Cambio a lo largo del tiempo en la NPI
    - Cambio desde basal hasta la semana 8 en la CGI-A
    - Cambio a lo largo del tiempo en la CGI-A
    - Cambio desde basal hasta la semana 8 en la MMSE en pacientes con Enfermedad de Alzheimer o Demencia de Cuerpos de Lewy
    - Cambio a lo largo del tiempo en la MMSE en pacientes con Enfermedad de Alzheimer en comparación con pacientes con Demencia de Cuerpos de Lewy
    - Cambio desde basal hasta la semana 8 en la ADHD-RS en pacientes con Trastorno de Déficit de Atención e Hiperactividad
    - Cambio a lo largo del tiempo en la ADHD-RS en pacientes con Trastorno de Déficit de Atención e Hiperactividad
    - Cambio desde basal hasta la semana 8 en la ADOS en pacientes con Trastorno del Espectro Autista
    - Cambio a lo largo del tiempo en la ADOS en pacientes con Trastorno del Espectro Autista
    - Cambio desde basal hasta la semana 8 en la BPDCL en pacientes con Trastorno Límite de la Personalidad
    - Cambio a lo largo del tiempo en la BPDCL en pacientes con Trastorno Límite de la Personalidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 semanas
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    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 months9
    E.8.9.1In the Member State concerned days
    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: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state30
    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)
    Not different from the expected normal treatment for Alzheimer’s Disease (AD), Lewy Body Dementia (LBD), Adult attention deficit hyperactivity disorder (ADHD), Borderline Personality Disorder (BPD), Autism Spectrum Disorder (ASD)
    Ningún tratamiento diferente al esperado para Enfermedad de Alzheimer, Demencia de Cuerpos de Lewy, Trastorno por Déficit de
    Atención e Hiperactividad, Trastorno Límite de la Personalidad y Trastorno del Espectro Autista
    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 Decision2018-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-22
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA