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    Summary
    EudraCT Number:2017-002455-29
    Sponsor's Protocol Code Number:15-AVP-786-303
    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:2018-08-07
    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 number2017-002455-29
    A.3Full title of the trial
    A Phase 3, Multicenter, Long-term, Extension Study of the Safety and Efficacy of AVP-786
    (deuterated [d6] dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the Treatment of Agitation in Patients with Dementia of the Alzheimer’s Type
    Estudio de extensión en fase III, multicéntrico, a largo plazo sobre la seguridad y eficacia de AVP-786 (bromhidrato de [d6]-dextrometorfano deuterado [d6-DM]/sulfato de quinidina [Q]) para el tratamiento de la agitación en pacientes con demencia de tipo Alzheimer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extension Study of AVP-786 in the Treatment of Subjects with Agitation Associated with Dementia of the Alzheimer's Type
    Estudio de extensión de AVP-786 para el tratamiento de pacientes con agitación asociada a la demencia de tipo Alzheimer.
    A.4.1Sponsor's protocol code number15-AVP-786-303
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02446132
    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 SponsorAvanir Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAvanir Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAvanir Pharmaceuticals Inc.
    B.5.2Functional name of contact pointAgitation Project Team
    B.5.3 Address:
    B.5.3.1Street Address30 Enterprise, Suite 400
    B.5.3.2Town/ cityAliso Viejo, California
    B.5.3.3Post code92656
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019492685912
    B.5.5Fax number0019492422486
    B.5.6E-mail15.AVP.786.303@avanir.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 nameAVP-786 (d6-DM 18/Q 4.9) (d6-DM: deudextromethorphan hydrobromide, Q: quinidine sulphate)
    D.3.2Product code AVP-786
    D.3.4Pharmaceutical form Capsule, hard
    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 INNDEUDEXTROMETHORPHAN
    D.3.9.1CAS number 1373497-18-7
    D.3.9.2Current sponsor coded6-DM
    D.3.9.3Other descriptive nameDeudextromethorphan Hydrobromide
    D.3.9.4EV Substance CodeSUB191183
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNQuinidine Sulfate
    D.3.9.1CAS number 6591-63-5
    D.3.9.2Current sponsor codeQ
    D.3.9.3Other descriptive nameQUINIDINE SULFATE DIHYDRATE
    D.3.9.4EV Substance CodeSUB15083MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.9
    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 nameAVP-786 (d6-DM 28/Q 4.9) (d6- DM: deudextromethorphan hydrobromide, Q: quinidine sulphate)
    D.3.2Product code AVP-786
    D.3.4Pharmaceutical form Capsule, hard
    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 INNDEUDEXTROMETHORPHAN
    D.3.9.1CAS number 1373497-18-7
    D.3.9.2Current sponsor coded6-DM
    D.3.9.3Other descriptive nameDeudextromethorphan Hydrobromide
    D.3.9.4EV Substance CodeSUB191183
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number28
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNQuinidine Sulfate
    D.3.9.1CAS number 6591-63-5
    D.3.9.2Current sponsor codeQ
    D.3.9.3Other descriptive nameQUINIDINE SULFATE DIHYDRATE
    D.3.9.4EV Substance CodeSUB15083MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.9
    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: 3
    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 nameAVP-786 (d6-DM 42.63/Q 4.9) (d6- DM: deudextromethorphan hydrobromide, Q: quinidine sulphate)
    D.3.2Product code AVP-786
    D.3.4Pharmaceutical form Capsule, hard
    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 INNDEUDEXTROMETHORPHAN
    D.3.9.1CAS number 1373497-18-7
    D.3.9.2Current sponsor coded6-DM
    D.3.9.3Other descriptive nameDeudextromethorphan Hydrobromide
    D.3.9.4EV Substance CodeSUB191183
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number42.63
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNQuinidine Sulfate
    D.3.9.1CAS number 6591-63-5
    D.3.9.2Current sponsor codeQ
    D.3.9.3Other descriptive nameQUINIDINE SULFATE DIHYDRATE
    D.3.9.4EV Substance CodeSUB15083MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.9
    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
    Agitation Associated with Dementia of the Alzheimer's Type
    Agitación asociada con demencia de tipo Alzheimer
    E.1.1.1Medical condition in easily understood language
    Agitation behavior associated with Alzheimer's disease
    Comportamiento agitado asociado con 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 PT
    E.1.2Classification code 10001497
    E.1.2Term Agitation
    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
    Evaluation of the long-term safety and maintenance of efficacy of AVP-786 for the treatment of agitation in patients with dementia of the Alzheimer’s type.
    Evaluación de la seguridad a largo plazo y el mantenimiento de la eficacia de AVP-786 para el tratamiento de la agitación en pacientes con demencia de tipo Alzheimer.
    E.2.2Secondary objectives of the trial
    None
    Ninguno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient has successfully completed Studies 15-AVP-786 301, 15-AVP-786-302, 17-AVP-786-305, or 12-AVR-131 and is deemed eligible for enrollment by the investigator after review of the inclusion/exclusion criteria.

    Patient has stable cardiac, pulmonary, hepatic, and renal function.

    If female of childbearing potential, must have been practicing a medically-acceptable method of birth control and continue with the same method during the entire study duration (oral contraceptive tablets,
    hormonal implant device, hormone patch, intrauterine device, diaphragm and contraceptive cream or foam, condom with spermicide, or abstinence) or be surgically sterile or post-menopausal.

    Patients from Study 12-AVR-131 must not show current and significant symptoms of a depressive disorder and must have a score <10 in the Cornell Scale for Depression in Dementia (CSDD) at Screening
    for. Patients rolling over from Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305 with scores greater than 10 in the CSDD at baseline should be evaluated by the investigator for enrollment in the current study.

    Caregiver must be willing and able to comply with study procedures, including not administering any prohibited medications during the course of the study.

    Patient/caregiver must be willing to sign and receive a copy of patient/caregiver informed consent form (ICF) after the nature and risks of study participation have been fully explained. Patients who are not capable of signing the ICF but are able to provide assent, or the patient's authorized representative agrees to participation (for patients unable to provide assent) are allowed.
    El paciente ha concluido con éxito los estudios 15-AVP-786 301, 15-AVP-786-302, 17-AVP-786-305 o 12-AVR-131 y el investigador le considera apto para la inscripción, después de haber revisados los criterios de inclusión y exclusión.

    Las funciones renal, hepática, pulmonar y cardíaca del paciente son estables.

    En el caso de las mujeres con capacidad de concebir, deben estar utilizando un método anticonceptivo aceptable desde el punto de vista médico y deben continuar usando el mismo método durante todo el tiempo que dure el estudio, (anticonceptivos orales en comprimidos, dispositivos hormonales implantables, parche hormonal, dispositivo intrauterino, diafragma y crema o espuma anticonceptiva, preservativo con espermicida, o abstinencia sexual) o ser quirúrgicamente estériles o posmenopáusicas.

    Los pacientes del estudio 12-AVR-131 no deben mostrar síntomas importantes de trastorno depresivo y deben tener una puntuación <10 en la Escala de Cornell para la Depresión en la Demencia (CSDD) en la selección. Los pacientes procedentes de los estudios 15-AVP-786-301, 15-AVP-786- 302 y 17-AVP-786-305 con puntuaciones superiores a 10 en la CSDD al inicio deben ser evaluados por el investigador para su inscripción en este estudio.

    El cuidador debe tener la capacidad y la voluntad de cumplir con los procedimientos del estudio, por ejemplo, no administrar ningún medicamento prohibido durante el estudio.

    El paciente/cuidador debe estar dispuesto a firmar el formulario de consentimiento informado (FCI) para el paciente/cuidador y recibir una copia después de la explicación minuciosa de la naturaleza y los riesgos de la participación en el estudio. Se permite participar a los pacientes que no sean capaces de firmar el FCI pero que puedan otorgar su asentimiento, y a los pacientes cuyo representante autorizado permita la participación (en el caso de pacientes incapaces de dar el asentimiento).
    E.4Principal exclusion criteria
    Patient is currently participating in, or has participated in other interventional (drug or device)
    clinical study since exiting Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, or within 30 days prior to baseline for patients from Study 12-AVR-131.

    Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions.

    Patients with co-existent clinically significant or unstable systemic diseases that could confound
    the interpretation of the safety results of the study (e.g., malignancy [except skin basal-cell carcinoma or untreated prostate cancer], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary,
    renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease). Certain other nonmetastatic cancer
    may be allowed. For patients from Study 12-AVR-131, each case to be evaluated individually with the Medical Monitor (MM).

    Patients determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator

    Patients who are currently using or were on NUEDEXTA® in the 2 weeks preceding Baseline.

    Patients with evidence of serious risk of suicide at Screening (patients from Study 12-AVR-131) and Baseline based on the Sheehan Suicidality Tracking Scale (S-STS), i.e., a score of 3 or 4 on any one question 2 through 6 or 11 or a score of 2 or higher on any one questions 1a, 7 through 10, or 12, or who, in the opinion of the investigator, present a serious risk of suicide.
    El paciente participa actualmente o ha participado en otro estudio clínico intervencionista (fármaco o dispositivo) desde que saliera de los estudios 15-AVP-786-301, 15-AVP-786-302 y 17-AVP-786-305 o en el plazo de 30 días antes del inicio para los pacientes del estudio 12 AVR-131.

    El cuidador no está dispuesto o no puede, en opinión del investigador, cumplir con las instrucciones del estudio.

    Pacientes con enfermedades sistémicas coexistentes clínicamente significativas o inestables que podrían frustrar la interpretación de los resultados de la seguridad del estudio (p. ej., neoplasia maligna [excepto carcinoma basocelular o cáncer de próstata no tratado], hipertensión o diabetes mal controladas, enfermedad pulmonar, renal o hepática inestable, cardiopatía isquémica inestable, miocardiopatía dilatada o cardiopatía valvular inestable). Es posible que estén permitidos otros cánceres no metastásicos. En el caso de los pacientes del estudio 12-AVR-131, cada caso será evaluado individualmente con el monitor médico (MM).

    Los pacientes con un riesgo de caídas inminente y elevado, determinado durante el estudio sobre la base de una evaluación clínica efectuada por el investigador.

    Los pacientes que actualmente usen o haya utilizado NUEDEXTA® en las dos semanas anteriores al inicio.

    Pacientes que en la selección (pacientes del estudio 12-AVR-131) y en la visita inicial muestran indicios de riesgo elevado de suicidio de acuerdo con la Escala de Seguimiento del Riesgo Suicida de Sheehan (S-STS), esto es, con una puntuación de 3 o 4 en alguna de las preguntas de la 2 a la 6, o en la 11, o una puntuación igual o superior a 2 en alguna de las preguntas de la 7 a la 10, en la 1a o en la 12, o que, en opinión del investigador, presentan un riesgo alto de suicidio.
    E.5 End points
    E.5.1Primary end point(s)
    SAFETY: Safety and tolerability of AVP-786 will be assessed by reported adverse events (AEs), physical and neurological examinations, vital signs, clinical laboratory assessments, resting 12-lead electrocardiograms (ECGs), Sheehan Suicidality Tracking Scale (S-STS), Mini Mental State Examination (MMSE), and the Epworth Sleepiness Scale (ESS). Pregnancy tests will be conducted for females of childbearing potential.
    SEGURIDAD: La seguridad y la tolerabilidad de AVP-786 se evaluarán a través de los acontecimientos adversos (AA) notificados, las exploraciones físicas y neurológicas, las constantes vitales, los análisis clínicos, los electrocardiogramas (ECG) de 12 derivaciones en reposo, la Escala de Seguimiento del Riesgo Suicida de Sheehan (S-STS, Sheehan Suicidality Tracking Scale), el Miniexamen del Estado Mental (MMSE, Mini Mental State Examination) y la Escala de Somnolencia de Epworth (ESS, Epworth Sleepiness Scale). Se harán pruebas de embarazo a las mujeres con capacidad de concebir.
    E.5.1.1Timepoint(s) of evaluation of this end point
    AE (every visit), PE (Baseline and V8), VS (every visit minus f/u), CLA (Baseline, V2, V3, V4, V5, V6, V7, V8), ECG (Baseline, V2, V3, V4, V5, V6, V7, V8), S-STS (All visits), MMSE (Baseline, V5 and V8), ESS (Baseline, V5 and V8), Pregnancy (Baseline, V2, V3, V4, V5, V6, V7, V8).
    AA (en cada visita), EF (al inicio y V8), CV (cada visita menos seguimiento), CLA (inicio, V2, V3, V4, V5, V6, V7, V8), ECG (inicio, V2, V3, V4, V5, V6, V7, V8), S-STS (todas las visitas), MMSE (inicio, V5 y V8), ESS (inicio, V5 y V8), embarazo (inicio, V2, V3, V4, V5, V6, V7, V8).
    E.5.2Secondary end point(s)
    EFFICACY: Efficacy will be assessed using the Cohen-Mansfield Agitation Inventory (CMAI), Neuropsychiatric Inventory (NPI) agitation/aggression, irritability/lability, and aberrant motor behavior domains, modified Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change-Agitation (mADCS-CGICAgitation), Clinical Global Impression of Severity of Illness scale-Agitation (CGIS-Agitation), Patient Global Impression of Change (PGIC-rated by caregiver), Dementia Quality of Life (DEMQOL), Resource Utilization in Dementia (RUD) and EuroQol 5-Dimension 5-Level (EQ-5D-5L).
    EFICACIA: La eficacia se evaluará mediante el Inventario de agitación de Cohen-Mansfield (CMAI, Cohen-Mansfield Agitation Inventory), los dominios de agitación/agresividad, irritabilidad/labilidad y comportamiento motor aberrante del Inventario neuropsiquiátrico (NPI, Neuropsychiatric Inventory), la escala modificada de impresión global del cambio en la agitación del Estudio Cooperativo de la Enfermedad de Alzheimer (modified Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change-Agitation, mADCS-CGIC-Agitation), la escala de impresión clínica global de la gravedad de la enfermedad para agitación (CGIS-Agitation, Clinical Global Impression of Severity of Illness scale-Agitation), la impresión global del cambio por parte del paciente (PGIC, Patient Global Impression of Change) evaluada por el cuidador, el cuestionario de calidad de vida en la demencia (DEMQOL, Dementia Quality of Life), la escala de utilización de recursos sanitarios en la demencia (RUD, Resource Utilization in Dementia) y el cuestionario EuroQol de 5 dimensiones y 5 niveles (EQ-5D-5L, EuroQol 5-Dimension 5-Level).
    E.5.2.1Timepoint(s) of evaluation of this end point
    CMAI (Baseline, V4, V5, V6, V8, F/U V1&2), NPI agitation/aggression (Baseline, V4, V5, V6, V8), NPI irritability/lability and aberrant motor behavior domains (Baseline, V5, V8), mADCS-CGICAgitation (Baseline, V5, V8, F/U V1&2), CGIS-Agitation (Baseline, V4, V5, V6, V8), PGIC-rated by caregiver (Baseline, V4, V5, V6, V8), DEMQOL (Baseline, V5, V8), RUD (Baseline, V5, V8) and EQ-5D-5L (Baseline, V5, V8).
    El CMAI inglés (inicio, V4, V5, V6, V8, seguimiento V1 y V2), agitación/agresión de NPI (inicio, V4, V5, V6, V8), irritabilidad/labilidad de NPI y dominios de comportamiento motor aberrante (inicio, V5, V8), Agitación mADCS-CGIC (inicio, V5, V8, seguimiento V1 y V2), Agitación-CGIS (inicio, V4, V5, V6, V8), PGIC evaluado por el cuidador (inicio, V4, V5, V6, V8), DEMQOL (inicio, V5, V8), RUD (inicio, V5, V8) y EQ-5D-5L (inicio, V5, V8).
    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 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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    AVP-786-18/4,9, AVP-786-28/4,9 y AVP-786-42,63/4,9
    AVP-786-18/4,9, AVP-786-28/4,9 y AVP-786-42,63/4,9
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Australia
    Belgium
    Bulgaria
    Canada
    Czech Republic
    France
    Hungary
    Italy
    Poland
    Romania
    South Africa
    Spain
    United Kingdom
    United States
    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
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 750
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with agitation secondary to dementia of the Alzheimer's type.
    Pacientes con agitación secundaria a demencia de Tipo Alzheimer.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 405
    F.4.2.2In the whole clinical trial 1000
    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)
    After a patient has ended the study, usual treatment will be
    administered.
    Después de que un paciente haya terminado el estudio, le será administrado el tratamiento habitual.
    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 Decision2018-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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