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    Summary
    EudraCT Number:2008-005144-16
    Sponsor's Protocol Code Number:MRZ 90001-AD-3001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-20
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2008-005144-16
    A.3Full title of the trial
    Open-label, single-arm, multi-center validation study of the ROSA-Scale (Relevant Outcome Scale for Alzheimer Patients) in patients with dementia of Alzheimer’s type (DAT) treated with memantine over a 3 months period
    A.3.2Name or abbreviated title of the trial where available
    ROSA Validation Study
    A.4.1Sponsor's protocol code numberMRZ 90001-AD-3001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerz Pharmaceuticals GmbH
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name Axura
    D.2.1.1.2Name of the Marketing Authorisation holderMerz Pharmaceuticals GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAxura
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNmemantine hydrochloride
    D.3.9.1CAS number 41100-52-1
    D.3.9.3Other descriptive name3,5-dimethyl-1-adamantanamine hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5- to 20
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Dementia of Alzheimer's Type (DAT) of all severity stages
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11.0
    E.1.2Level LLT
    E.1.2Classification code 10012271
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to validate the ROSA-Scale (Relevant Outcome Scale for Alzheimer Patients) content, reliability and responsiveness for detecting changes in the symptoms of the DAT disease (Dementia of Alzheimer's Type).
    E.2.2Secondary objectives of the trial
    The secondary objective is to determine DAT severity ((Dementia of Alzheimer's Type) and other symptoms using Global Deterioration Scale [GDS], the Clinical Global Impression Scale: Global Improvement [CGI-C], Alzheimer’s Disease Assessment scale –cognitive subscale [ADAS-cog], Severe Impairment Battery [SIB], Neuropsychiatric Inventory Questionnaire [NPI-Q], Disability assessment for dementia [DAD] and to examine the times to perform these scales.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or female impatient or outpatient of at least 50 years of age
    2) The patient has a diagnosis of probable Alzheimer’s disease
    [AD] consistent with the National Institute of Neurological
    and Communicative Disease and Stroke/Alzheimer’s
    Disease
    and Related Disorders Association (NINCDS-ADRDA)
    criteria or with the Diagnostic and Statistical Manual
    Disorders (DSM IV TR) criteria for DAT.
    3) Signed informed consent prior to the initiation of any study
    specific procedures.
    4) If female, patient is at least 2 years post menopausal or
    surgically sterile.
    5) Sight and hearing (a hearing aid is permitted) are sufficiently
    good to allow the undertaking of study-related procedures
    and psychometric tests.
    6) According to the investigators opinion, the patient will be
    capable of completing all study-related activities.
    E.4Principal exclusion criteria
    1) Patient is currently treated with memantine or has been
    treated with memantine within a period of 6 months prior to
    the screening visit.
    2) Intake of any medications that is contra-indicated (see
    protocol Appendix A – Authorized/Non-Authorized
    medication).
    3) Evidence of clinically significant and active pulmonary,
    gastrointestinal, renal, hepatic, endocrine, or cardiovascular
    system disease
    (Note: patients with controlled diabetes and hypertension can
    be included, provided they do not use unauthorized
    concomitant medication).
    4) Clinically significant or currently untreated B12, TSH or
    folate deficiency within 2 months prior to screening
    (Note: patients with thyroid disease may be included in the
    study, provided they are stable and euthyroid).
    5) History of severe drug allergy, or hypersensitivity, or patients
    with known hypersensitivity to ingredients of IMP and/or
    lactose.
    6) Current evidence of clinically significant, unstable central
    nervous system or psychiatric disease (other than symptoms
    associated with AD) including bipolar or unipolar depression.
    7) Lifetime diagnosis of psychotic disorder other than symptoms
    associated with Alzheimer’s disease.
    8) Oncological diagnosis (hematological or solid tumor) which
    is currently under treatment or with evidence of active
    disease.
    9) Known or suspected history of alcoholism or drug abuse
    eithin the past 2 years.
    10) Participation in an investigational drug study within 60 days
    (or 10 half-lives of the investigational drug, whichever is
    longer) prior to the screening visit.
    11) Any disease or medical treatment, which, according to the
    investigator’s judgment, could interfere with the assessments
    of safety, tolerability or efficacy.
    12) Unwillingness or unability of the patient or the patient and
    his/her carers to abide by the visit schedule and other study
    requirements (e.g. insufficient hearing ability).
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable is the ROSA-Scale. The objective is
    to validate the ROSA-Scale content, reliability and
    responsiveness for detecting changes in the symptoms of
    the DAT disease and to analyze the data psychometrically
    according to classical test theory (determination of internal
    consistency, test-retest reliability, construct validity, and
    responsiveness).
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Validation ROSA scale
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned50
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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
    severe stages of DAT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state380
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 450
    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 Decision2008-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-11-11
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