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    Summary
    EudraCT Number:2017-002455-29
    Sponsor's Protocol Code Number:15-AVP-786-303
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-05-30
    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 ConcernedHungary - National Institute of Pharmacy
    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
    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
    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 200
    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.786.303@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 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 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: 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/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: 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
    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
    E.1.1.1Medical condition in easily understood language
    Agitation behavior associated with Alzheimer's disease
    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.
    E.2.2Secondary objectives of the trial
    None
    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 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.
    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.
    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.
    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).
    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).
    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).
    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 No
    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
    different dose of AVP-786 depending on the last treatment received in the preceding study
    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 concerned8
    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
    Canada
    South Africa
    United States
    Belgium
    Bulgaria
    France
    Hungary
    Italy
    Poland
    Romania
    Spain
    United Kingdom
    Czechia
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years5
    E.8.9.2In all countries concerned by the trial months0
    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
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 1200
    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.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-23
    P. End of Trial
    P.End of Trial StatusOngoing
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