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    Summary
    EudraCT Number:2010-020737-50
    Sponsor's Protocol Code Number:MRZ90001_2267_1
    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:2010-08-24
    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 number2010-020737-50
    A.3Full title of the trial
    Prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of 10mg memantine in the treatment of memory, concentration or attention problems (subjective cognitive impairment) in the absence of dementia
    A.3.2Name or abbreviated title of the trial where available
    EUREKA
    A.4.1Sponsor's protocol code numberMRZ90001_2267_1
    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 Pharmaceutical 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 number10
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Subjective memory, concentration or attention problems (subjective cognitive impairment) in the absence of dementia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10003729
    E.1.2Term Attention concentration difficulty
    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 investigate the efficacy and safety of 10mg/day memantine in comparison to placebo in the treatment of memory, concentration or attention problems (subjective cognitive impairment) in the absence of dementia.
    E.2.2Secondary objectives of the trial
    To investigate the efficacy of 10mg memantine in comparison to placebo measured by the CogState computer-based neuropsychological test battery [C-NTB], Everyday Cognition 39 [ECog 39], and Hospital Anxiety and Depression Scale [HADS]
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained from the subject, 2. Understanding of study procedures and willingness to abide by all procedures during the course of the study, 3. Age ≥50 and ≤80, 4. Subjective worsening of memory, concentration or attention problems for longer than 6 months, 5. Woman of childbearing potential must be using a highly effective method of birth control, 6. Subject can confirm that a relative or friend has noticed the memory, concentration or attention problems of the subject, 7.“Patient Global Impression Severity” (PGI-S) score of ≥3, 8. Experience of the memory, concentration or attention problems at least four times per week, 9. MiniCog score of 3 or more
    E.4Principal exclusion criteria
    1. Memory, concentration or attention problems interfere with basic daily activities,
    2. Significant neurological disease or major psychiatric disorder (e.g. diagnosis of psychosis or dementia). 3. Epilepsy or history of epileptic fits (inclusion questionnaire, 4. Severe or acute mental illness (depression or anxiety),
    5. Significant systemic illness, such as cancer, kidney failure, severe hepatic impairment, uncontrolled diabetes, 6. Heart attack, heart failure, arrhythmia or carotid stenosis within the last 6 months, 7. History of stroke or transient ischaemic attacks within the last 6 months, 8. Diagnosed pulmonary, gastrointestinal, hepatic, endocrine, untreated B12, TSH or folate deficiencies, 9. Sleep apnea, 10. Weight below 40kg or above 100kg, 11. Previous or current treatment with memantine or participation in an investigational study with memantine, 12. Con- current use of medication that could have effects on cognition ( seelist in the protocol, 8.3), 13. Taking any medications that are contra-indicated in combination with memantine(see SmPC), 14. Known or suspected history of alcoholism or drug abuse within the past 2 years, 15. Known hypersensitivity to the IP or reference, or any of their formulation ingredients, 16. Subject who is imprisoned or is lawfully kept in an institution, 17. Employee or direct relative of an employee of the CRO, the study site, or Merz, 18. Participation in a clinical study for an IP within the previous 90 days prior to visit 2, 19. Previous participation in this clinical study, 20. Clinically significant laboratory results, which may indicate a cause for cognitive symptoms
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is defined as “Patient Global Impression of Change” (PGI-C) at visit 4. The primary efficacy analysis is the statistical comparison between the placebo group and the memantine group at Visit 4 in the Full Analysis Set [FAS] where missing values will be imputed using the Last observation carried forward [LOCF] approach. The group comparison will be performed by the use of an analysis of covariance (ANCOVA) model, with treatment group, “Patient Global Impression Severity” (PGI-S) at screening, gender, age, education, and pooled center as factors. Additionally a reduced ANCOVA model with treatment group and pooled centers as factors will be used. To consider a possible violation of the assumptions of the non-parametric test a Cochan-Mantel-Haenszel test with modified ridit scores stratified by pooled centers will be performed. Furthermore a responder analysis using a logistic regression model will be performed with treatment group, PGI-S at screening, gender, age, education, and pooled centre as independent variables as well as a reduced responder analysis using treatment group and pooled center as independent variables. Response is defined as any improvement in the Subject Global Assessment of Change. Additionally summary statistics will be provided for raw values and the change to Visit 4.
    Sensitivity analyses of the results will be based on the FAS using observed cases, on the PPS using LOCF and on the PPS using observed cases.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    The end of the trial will be 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 years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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 Decision2010-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-12
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