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    Summary
    EudraCT Number:2017-002455-29
    Sponsor's Protocol Code Number:15-AVP-786-303
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-27
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio di estensione di fase 3, multicentrico, a lungo termine, sulla sicurezza e sull'efficacia di AVP-786 (destrometorfano bromidrato deuterato [d6-DM]/chinidina solfato [Q]) per il trattamento dell'agitazione
    in pazienti con demenza di 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
    Studio di estensione di AVP-786 nel trattamento di soggetti con agitazione associata a demenza di tipo Alzheimer
    A.3.2Name or abbreviated title of the trial where available
    Extension Study of AVP-786 in the Treatment of Subjects with Agitation Associated with Dementia of t
    Studio di estensione di AVP-786 nel trattamento di soggetti con agitazione associata a demenza di ti
    A.4.1Sponsor's protocol code number15-AVP-786-303
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02446132
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    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 (DESTROMETORFANO BROMIDRATO 18, CHINIDINA SOLFATO 4.9)
    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 INNDESTROMETORFANO
    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 INNCHINIDINA SOLFATO
    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 number5
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 (DESTROMETORFANO BROMIDRATO 28, CHINIDINA SOLFATO 4.9)
    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 INNDESTROMETORFANO
    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 INNCHINIDINA SOLFATO
    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 number5
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 (DESTROMETORFANO BROMIDRATO 42.63, CHINIDINA SOLFATO 4.9)
    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 INNDESTROMETORFANO
    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
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCHINIDINA SOLFATO
    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 number5
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Agitazione associata alla demenza di tipo Alzheimer
    E.1.1.1Medical condition in easily understood language
    Agitation behavior associated with Alzheimer's disease
    Comportamento agitato associato alla demenza di tipo 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.
    Valutare la sicurezza a lungo termine e il mantenimento dell'efficacia di AVP-786 per il trattamento
    dell'agitazione in pazienti affetti da demenza di tipo Alzheimer
    E.2.2Secondary objectives of the trial
    None
    Nessuno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 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 forenrollment by the investigator after review of theinclusion/exclusion criteria.
    8. Patient has stable cardiac, pulmonary, hepatic, and renal function.
    10. 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.
    15. 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.
    17. Caregiver must be willing and able to comply with study procedures, including not administering any
    prohibited medications during the course of the study.
    18. Patient/caregiver must be willing to sign and receive a copy of patient/caregiver informed consentform (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.
    1. Il paziente ha completato con successo gli studi 15-AVP-786 301, 15-AVP-786-302, 17-AVP-786-305 o 12-AVR-131
    ed è considerato idoneo all'arruolamento da parte dello sperimentatore dopo la revisione dei criteri di inclusione/esclusione.
    8. Il paziente ha una funzione cardiaca, polmonare, epatica e renale stabile.
    10. Se donna, in età fertile, deve aver praticato un metodo di controllo delle nascite accettabile dal punto di vista
    medico e continuare con lo stesso metodo durante l'intera durata dello studio(compresse contraccettive orali,
    dispositivo di impianto ormonale, cerotto ormonale, dispositivo intrauterino, diaframma e crema o schiuma contraccettiva,
    preservativo con spermicida, o astinenza) o essere chirurgicamente sterile o post-menopausa.
    15. I pazienti dello studio 12-AVR-131 non devono mostrare sintomi significativi e in corso di un disturbo depressivo
    e devono avere un punteggio <10 nella scala di Cornell per la depressione in demenza (CSDD) allo screening.
    I pazienti che passano dagli studi 15-AVP-786-301, 15-AVP-786-302 e 17-AVP-786-305 con punteggi superiori a 10
    nella CSDD al basale dovrebbero essere valutati dallo sperimentatore per l' arruolamento allo studio .
    17. Il caregiver deve essere disposto e in grado di rispettare le procedure di studio, incluso non somministrare
    farmaci vietati durante il corso dello studio.
    18. Il paziente/caregiver deve essere disposto a firmare e ricevere una copia del consenso informato per il paziente/
    caregiver (ICF) dopo che gli sono stati pienamente spiegati la natura e i rischi della partecipazione allo studio.
    Sono ammessi i pazienti che non sono in grado di firmare l'ICF ma sono in grado di fornire il loro assenso, o il
    rappresentante autorizzato del paziente che accetta la partecipazione (per i pazienti che non sono in grado di fornire
    il loro assenso)
    E.4Principal exclusion criteria
    1. 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.
    2. Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
    3. 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).
    4. Patients determined to have a high imminent risk of falls during the study based on a clinical evaluation by
    the investigator
    6. Patients who are currently using or were on NUEDEXTA® in the 2 weeks preceding Baseline.
    7. 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.
    1. Il paziente sta attualmente partecipando o ha partecipato a un altro studio clinic interventistico (farmaco o dispositivo)
    dall'uscita dagli studi 15-AVP-786-301, 15-AVP-786-302, e 17-AVP-786-305, o entro I 30 giorni precedent il basale per i
    pazienti provenienti dallo studio 12-AVR-131.
    2. Il caregiver non è disposto o èincapace, secondo il parere dello sperimentatore, a rispettare le istruzioni di studio.
    3. Pazienti con malattie sistemiche coesistenti clinicamente significative o instabili che potrebbero confondere
    l'interpretazione dei risultati di sicurezza dello studio (ad es. tumore maligno [eccetto carcinoma basocellulare
    della pelle o carcinoma prostatico non trattato], diabete non adeguatamente controllato, ipertensione non
    adeguatamente controllata, malattia polmonare, renale o epatica instabile, cardiopatia ischemica instabile,
    cardiomiopatia dilatativa o cardiopatia valvolare instabile). Alcuni altri tumori non metastatici potrebbero essere permessi.
    Per i pazienti provenienti dallo studio 12-AVR-131, ogni caso deve essere valutato singolarmente con Medical Monitor (MM).
    4. Pazienti determinati ad avere un imminente rischio elevato di cadute durante lo studio sulla base di una valutazione
    clinica da parte dello sperimentatore
    6. Pazienti che attualmente stanno utilizzando o utilizzavano NUEDEXTA® nelle 2 settimane precedenti il basale.
    7. Pazienti con evidenza di un grave rischio di suicidio allo Screening (pazienti provenienti dallo Studio 12-AVR-131)
    e al Basale sulla base della Sheehan Suicidality Tracking Scale(S-STS),ossia un punteggio di 3 o 4 su qualsiasi domanda
    dalla numero 2 alla numero 6 o al domanda 11 o un punteggio di 2 o superiore alla domanda 1a, o su qualsiasi domanda dalla
    numero 7 alla numero 10, o 12, o coloro I quali secondo il parere dello sperimentatore presentano un rischio grave di 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.
    SICUREZZA: la sicurezza e la tollerabilità di AVP-786 saranno valutate attraverso gli eventi avversi segnalati (AE), esami fisici e neurologici, I segni vitali, le valutazioni di laboratorio cliniche, l' elettrocardiogramma (ECG) a riposo a 12 derivazioni, la Sheehan Suicidality Tracking Scale (S-STS), la Mini Mental State Examination (MMSE) e la Epworth Sleepiness Scala (ESS). Verranno condotti test di gravidanza per le donne potenzialmente fertili.
    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).
    AE (ogni visita), PE (Basale e V8), VS (ogni visita eccetto quella di follow up), CLA (Basale, V2, V3, V4, V5, V6, V7, V8),
    ECG (Basale, V2, V3, V4, V5, V6, V7, V8), S-STS (tutte le visite), MMSE (Basale, V5 and V8), ESS
    (Baseline, V5 and V8), Gravidanza (Basale, 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).
    EFFICACIA: l'efficacia sarà valutata usando il Cohen-Mansfield Agitation Inventory (CMAI),
    i domini agitazione / aggressività, irritabilità / instabilità e comportamento motorio aberrante
    secondo l'Inventario Neuropsichiatrico (NPI), l' Alzheimer's Disease Cooperative Study-Clinical
    Global Impression of Change-Agitation (mADCS-CGICAgitation) modificato, Clinical Global
    Impression of Severity of Illness scale-Agitation (CGIS-Agitation), Patient Global Impression
    of Change (PGIC-valutato dal caregiver), Dementia Quality of Life (DEMQOL), Resource
    Utilization in Dementia (RUD) and EuroQol 5-Dimension 5-Level (EQ-5D-5L).
    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), PGICrated
    by caregiver (Baseline, V4, V5, V6, V8), DEMQOL (Baseline, V5,
    V8), RUD (Baseline, V5, V8) and EQ-5D-5L (Baseline, V5, V8).
    CMAI (Basale, V4, V5, V6, V8, F/U V1&2), NPI agitazione / aggressività
    (Basale, V4, V5, V6, V8), domini NPI di irritabilità / instabilità e
    comportamento motorio aberrante (Basale, V5, V8), mADCS-CGICAgitation
    (Basale, V5, V8, F/U V1&2), CGIS-Agitation (Basale, V4, V5, V6, V8), PGIC valutato
    dal caregiver (Basale, V4, V5, V6, V8), DEMQOL (Basale, V5, V8), RUD (Basale, V5,
    V8) and EQ-5D-5L (Basale, 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) Yes
    E.8.2.2Placebo No
    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 concerned6
    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 Information not present in EudraCT
    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
    Canada
    South Africa
    United States
    Belgium
    Bulgaria
    Czechia
    France
    Hungary
    Italy
    Poland
    Romania
    Spain
    United Kingdom
    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
    LVLS
    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
    Pazienti con agitazione secondaria alla demenza di tipo Alzheimer
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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.
    Dopo che un paziente ha terminato lo studio, verrà somministrato il trattamento abituale
    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 Decision2019-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
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