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    Summary
    EudraCT Number:2017-001339-38
    Sponsor's Protocol Code Number:17-AVP-786-305
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-12-22
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-001339-38
    A.3Full title of the trial
    A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-design study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer’s type
    Étude de phase III en schéma parallèle, multicentrique, randomisée, en double aveugle, contrôlée versus placebo, visant à évaluer l’efficacité, la sécurité et la tolérance de l’AVP-786 (hydrobromure de dextrométhorphane deutéré [d6-DM]/sulfate de quinidine [Q]) dans le traitement de l’agitation chez des patients atteints de démence de type Alzheimer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AVP-786 in the Treatment of Subjects with Agitation Associated
    with Dementia of the Alzheimer’s Type
    AVP-786 dans le traitement de l’agitation chez des patients atteints de démence de type Alzheimer.
    A.4.1Sponsor's protocol code number17-AVP-786-305
    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-mail17.AVP.786.305@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 (deudextromethorphan hydrobromide/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 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEUDEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE
    D.3.9.1CAS number 1373497-18-7
    D.3.9.2Current sponsor coded6-DM
    D.3.9.3Other descriptive nameDeudextromethorphan Hydrobromide
    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 INNDEUDEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE
    D.3.9.1CAS number 1373497-18-7
    D.3.9.2Current sponsor coded6-DM
    D.3.9.3Other descriptive nameDeudextromethorphan Hydrobromide
    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 INNDEUDEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE
    D.3.9.1CAS number 1373497-18-7
    D.3.9.2Current sponsor coded6-DM
    D.3.9.3Other descriptive nameDeudextromethorphan Hydrobromide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number42.63
    D.3.11 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
    Agitation Associated with Dementia of the Alzheimer's Type
    Agitation associée à une démence de type Alzheimer
    E.1.1.1Medical condition in easily understood language
    Agitation behavior associated with Alzheimer's disease
    Comportement agité associé à une démence de type 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
    Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
    Efficacité, sécurité d'emploi et tolérance de l'AVP-786 pour le traitement de l'agitation chez des patients atteints de démence de type Alzheimer
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of probable AD according to the 2011 NIA-AA working
    groups criteria.
    2. The patient has clinically significant, moderate/severe agitation at the
    time of screening and for at least 2 weeks prior to randomization.
    3. The diagnosis of agitation must meet the IPA provisional definition of agitation.
    4. CGIS-Agitation score is ≥ 4 (moderately ill) at Screening and Baseline.
    5. MMSE score between 6 and 26 (inclusive) at Screening and Baseline.
    6. Caregiver must be willing and able to comply with study procedures,including not administering any prohibited medications during the course of the study.
    1. Diagnostic de la MA probable selon les critères du groupe de travail NIA-AA de 2011.
    2. Le patient présente une agitation cliniquement significative, modérée / sévère
    au moment de la sélection et pendant au moins 2 semaines avant la randomisation.
    3. Le diagnostic d'agitation doit correspondre à la définition provisoire de l'agitation de l'IPA.
    4. Le score CGIS-Agitation est ≥ 4 (moyennement malade) à la sélection et à la visite de référence.
    5. Score MMSE compris entre 6 et 26 (inclus) à la sélection et à la visite de référence.
    6. L'aidant doit être disposé et capable de se conformer aux procédures de l'étude, incluant de ne pas administrer de médicaments interdits au cours de l'étude.
    E.4Principal exclusion criteria
    1. Patient has dementia predominantly of non-Alzheimer's type (e.g.,
    vascular dementia, frontotemporal dementia, Parkinson's disease,
    substance-induced dementia).
    2. Patients with symptoms of agitation that are not secondary to AD
    (e.g., secondary to pain, other psychiatric disorder, or delirium).
    3. Patients with myasthenia gravis (contraindication for quinidine).
    1. Le patient est principalement atteint de démence de type non-Alzheimer (par ex. la démence vasculaire, la démence frontotemporale, la maladie de Parkinson, démence induite par une substance).
    2. Patients présentant des symptômes d'agitation qui ne sont pas secondaires à la MA (par exemple, secondaire à la douleur, à d'autres troubles psychiatriques ou au délire).
    3. Patients atteints de myasthénie grave (contre-indication à la quinidine).
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline to Week 12 in the composite Cohen-Mansfield
    Agitation Inventory (CMAI) scores
    Changement entre la visite de référence et la semaine 12 dans le score de Cohen-Mansfield
    Agitation Inventory (CMAI)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The CMAI will be assessed at Screening (Day -28 to Day -1),
    Baseline (Day 1), Day 8 (Visit 2), Day 15 (Visit 2.1), Day 22
    (Visit 3), Day 43 (Visit 4), Day 64 (Visit 5), Day 85 (Visit 6), and Follow up
    visit (for ET patients).
    Le CMAI sera évalué lors de la visite de sélection (jour -28 à jour -1), la visite de référence (jour 1), jour 8 (visite 2), jour 15 (visite 2.1), jour 22 (Visite 3), jour 43 (visite 4), jour 64 (visite 5), jour 85 (visite 6) et lors de la visite de suivi (pour les patients sortant prématurément de l'étude (FP)).
    E.5.2Secondary end point(s)
    Change from Baseline to Week 12 (Day 85) in the following measures:
    Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC)-Agitation
    Neuropsychiatric Inventory (NPI)
    Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain
    Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
    Patient Global Impression of Change (PGIC)
    Dementia Quality of Life (DEMQOL)
    Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
    Resource Utilization in Dementia (RUD)
    EuroQol 5-Dimension 5-Level (EQ-5D-5L)
    Changement entre la visite de référence et la semaine 12(jour 85) dans les mesures suivantes:
    Étude coopérative sur la maladie d'Alzheimer - Impression clinique générale du changement (mADCS-CGIC) - Agitation
    Inventaire neuropsychiatrique (NPI)
    Aspect clinique global de la gravité de la maladie (CGIS) - domaine d'activité
    Étude coopérative sur la maladie d'Alzheimer - Impression clinique globale du changement (ADCS-CGIC)
    Impression globale de changement du patient (Patient Global Impression of Change (PGIC))
    Qualité de vie par rapport à la démence (DEMQOL)
    Echelle d'évaluation de la maladie d'Alzheimer - sous-échelle cognitive (ADAS-Cog)
    Utilisation des ressources dans la démence (RUD)
    EuroQol 5-Dimension 5-Level (EQ-5D-5L)
    E.5.2.1Timepoint(s) of evaluation of this end point
    mADCS-CGIC-Agitation:Day(d) 1,d43(Visit(v) 4),d85(v6 /ET), and Follow-up visit (for ET patients);NPI-Agitation/Aggression domain score and CaregiverDistress score:Screening (d-28 to d-1),d8 (v2), and d15(v2.1); NPI-AberrantMotorBehaviordomain: (d1), d22(v3),d43(v4),d64(v5),and d85(v6/ET); NPI-Irritability/Lability domain:(d1),d22 (v3),d43 (v4),d64(v5),and d85(v6/ET);Total NPI:(d1), d22(v3),d4(v4),d6 (v5),and d85(v6/ET);CGIS-Agitation: Screening (d-28 to d-1),(d1),d43(v4) ,and d85 (v6/ET);ADCS-CGIC-Overall:(d1),d85(v6/ET);PGIC: d43(v4) and d85(v6/ET); DEMQOL:(d1), d43 (v4),and d85(v6/ET) for patients withMMSE ≥10 at the d1;EQ-5D-5L: (d1),d43 (v4),and d85(v6/ET)for patients with MMSE ≥10;ADAS-cog:(d1)and d85(v6/ET) forpatients withanMMSEscoreof≥ 10 at the d1visit;RUD:(d1),d43 (v4),d85(v6/ET)
    mADCS-CGIC-Agitation: Jour(J) 1, J43(Visite(V)4),J85(V6/FP), et visite de suivi (en cas de FP);NPI-Agitation/Aggression domain score and Caregiver Distress score: Sélection(J-28 à J-1),J8(v2), et J15(v2.1); NPI-Aberrant Motor Behavior domain:J1, J22(v3),J43(v4),J64(v5),et J85(v6/FP); NPI-Irritability/Lability domain:J1,J22(v3),J43(v4),J64(v5),et J85(v6/FP);Total NPI:J1, J22(v3),J4(v4),J6(v5),et J85(v6/FP); CGIS-Agitation: Sélection(J-28 à J-1),J1,J43(v4),et J85(v6/FP); ADCS-CGIC-Overall:J1,J85(v6/FP); PGIC: J43(v4) et J85(v6/ET); DEMQOL:J1, J43(v4),et J85(v6/FP) pour les patients avec MMSE≥10 à J1; EQ-5D-5L: J1,J43(v4),et J85(v6/FP)pour les patients avec MMSE≥10;ADAS-cog:J1et J85(v6/FP) pour les patients avec score MMSE ≥ 10 à la visite J1; RUD:(J1),J43 (v4),J85(v6/FP)
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Bulgaria
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Poland
    South Africa
    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
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 103
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 309
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with agitation secondary to dementia of the Alzheimer’s type
    Patients atteints d'agitation associée à une démence de type Alzheimer
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 412
    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)
    YES - Patients will have the opportunity to continue treatment and
    enter into a planned long term extension study.
    After a patient has ended the study, usual treatment will be administered.
    OUI - Les patients auront la possibilité de poursuivre le traitement et d'être inclus dans une étude de suivi à long terme.
    Après qu'un patient a terminé l'étude, son traitement habituel sera administré.
    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 Decision2018-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-14
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