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    The EU Clinical Trials Register currently displays   43841   clinical trials with a EudraCT protocol, of which   7281   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-008005-21
    Sponsor's Protocol Code Number:DIM18
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-05-14
    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 ConcernedFinland - Fimea
    A.2EudraCT number2008-008005-21
    A.3Full title of the trial
    CONCERT: A Phase 3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Twelve-Month Safety and Efficacy Study Evaluating Dimebon in Patients with Mild-to-Moderate Alzheimer’s Disease on Donepezil
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An International Twelve-Month Trial Evaluating the Safety and Effectiveness of Dimebon in Patients With Mild to Moderate Alzheimer’s Disease Who are Taking Donepezil
    A.3.2Name or abbreviated title of the trial where available
    CONCERT
    A.4.1Sponsor's protocol code numberDIM18
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00829374
    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 SponsorMedivation, 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 supportMedivation, Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportPfizer Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedivation Inc.
    B.5.2Functional name of contact pointMedical Officer
    B.5.3 Address:
    B.5.3.1Street Address201 Spear Street
    B.5.3.2Town/ citySan Francisco, CA
    B.5.3.3Post code94105
    B.5.3.4CountryUnited States
    B.5.4Telephone number1415543 3470
    B.5.5Fax number1415543 3411
    B.5.6E-mailinfo@medivation.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 nameDimebon
    D.3.2Product code Dimebon
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNDimebon dihydrochloride
    D.3.9.1CAS number 97657-92-6
    D.3.9.2Current sponsor codeDimebon
    D.3.9.3Other descriptive nameDimebon dihydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 nameDimebon
    D.3.2Product code Dimebon
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNDimebon dihydrochloride
    D.3.9.1CAS number 97657-92-6
    D.3.9.2Current sponsor codeDimebon
    D.3.9.3Other descriptive nameDimebon dihydrochloride
    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 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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Alzheimer's Disease
    E.1.1.1Medical condition in easily understood language
    Alzheimer’s Disease is a brain disease that causes problems with memory, thinking and behaviour.
    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 13.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Co-Primary Objectives
    •To evaluate the efficacy of Dimebon as compared to placebo on the primary measure of cognition and memory, the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog);
    •To evaluate the efficacy of Dimebon as compared to placebo on a measure of self-care and daily function, the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL).
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of Dimebon as compared to placebo on the primary measure of global function, the Clinician’s Interview-Based Impression of Change, plus caregiver input (CIBIC-plus);
    •To evaluate the efficacy of Dimebon as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI);
    •To evaluate the pharmacoeconomic benefit of Dimebon as compared with placebo using the Resource Utilization in Dementia Lite (RUD Lite©) instrument;
    •To evaluate quality of life using the EuroQoL 5 Domain Health Quality Assessment (EQ-5D) instrument;
    •To evaluate the safety and tolerability of Dimebon at two doses, 20 mg orally three times per day (TID) and 5 mg orally TID over 52 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Are men and women ≥ 50 years of age with a diagnosis of probable AD according to the following criteria:
    a. Diagnostic and Statistical Manual of Mental Disorders-IV Text Revision (DSM-IV-TR) as listed in Appendix A in the Protocol;
    b. National Institute of Neurological and Communicative Disorders and Stroke – Alzheimer’s Disease and Related Disorder Association’s Criteria (NINCDS-ADRDA) for probable AD as listed in Appendix B in the Protocol;
    c. Screening MMSE score between 12 and 24, inclusive;
    d. Modified Hachinski Ischemic Score ≤ 4 (Appendix C in the Protocol);

    4. Have been taking the cholinesterase inhibitor, donepezil, at a stable dose of 10 mg daily for at least four months prior to Day 1 (and with no intent to change for the duration of the study);
    E.4Principal exclusion criteria
    1 Have major structural brain disease (eg ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region);
    2 Have any major medical illness or unstable medical condition w/in 6mos of Screening that may interfere with the patient’s ability to comply with study procedures and abide by study restrictions, or with the ability to interpret safety data, including:
    -Any physical disability that would prevent completion of study procedures or assessments;
    -A diagnosis of diabetes mellitus requiring insulin treatment;
    -A history of cancer w/in 5yrs of enrollment with the exception of nonmelanoma skin cancers or prostate cancer that has been stable for 6mos, or AJCC Stage 0 or 1 cancers that have a remote probability of recurrence, in the opinion of the investigator, in consultation with the Sponsor;
    -The following cardiovascular parameters:
    •Hypotension (sitting SBP < 86mmHg) or bradycardia with a sitting HR < 50bpm at Screening or Day 1 or on > 1 occasion within 3mos prior to enrollment;
    •Uncontrolled hypertension as indicated by a resting SBP > 170mmHg or DBP > 105mmHg at Screening or Day 1 or on > 1 occasion w/in 3mos prior to enrollment;
    •A corrected QTcF greater than 470msec on an ECG at the Screening or Day 1 visit, based on the value from central over read (screening ECG may be repeated 1x, if medically indicated in the opinion of the investigator);
    •Cardiovascular disease including any of the following: unstable angina, decompensated congestive heart failure, clinically relevant arhythmias. NOTE: A history of these conditions is acceptable, if stable under medical management. Patients with pacemakers or patients on anticoagulant therapy may be included;
    •Active cardiovascular disease.
    -A history of traumatic brain injury with residual neurological deficit or stroke;
    -A diagnosis of a CNS disease other than AD;
    -A history of epilepsy or seizure disorder requiring ongoing treatment, or any seizure or loss of consciousness w/in 6mos prior to enrollment;
    -Any current psychiatric diagnosis according to DSM-IV-TR that may interfere with the patient’s ability to perform the study and all assessments (eg, alcohol or drug-related abuse or alcohol dependence, or alcohol or drug-related dementia, major depression, mental retardation, schizophrenia, bipolar disorder, etc).
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    Efficacy outcome measures in this study include the following:
    1. Co-primary outcome measures in this study:
    a. A comparison between the mean change from Baseline to Week 52 in the Dimebon 20 mg TID treatment group and the placebo group on the ADAS-cog;
    b. A comparison between the mean change from Baseline to Week 52 in the Dimebon 20 mg TID treatment group and the placebo group on the ADCS-ADL;

    E.5.1.1Timepoint(s) of evaluation of this end point
    • Twelve months
    E.5.2Secondary end point(s)
    2. Key secondary outcome measures in this study include:
    a. A comparison between the mean change from Baseline to Week 52 of the Dimebon 20 mg TID treatment group and the placebo group on the Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus);
    b. A comparison between the mean change from Baseline to Week 52 of the Dimebon 20 mg TID treatment group and the placebo group on the NPI;
    f. RUD Lite© and EQ-5D data summarized descriptively by treatment group.
    Safety:
    The safety of Dimebon will be assessed by the frequency of serious adverse events, the frequency of discontinuation of Dimebon treatment due to an adverse event, the frequency and severity of adverse events, as well as the frequency of new laboratory and ECG abnormalities among the three treatment groups. Safety measures thus include adverse events, vital signs, physical examinations, ECGs, and clinical laboratory testing.
    Pharmacokinetics:
    Dimebon plasma concentrations will be measured at Baseline and Week 13. The impact of covariates will be evaluated in order to identify underlying factors responsible for the variability of PK parameters and to identify sub-populations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Twelve months
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    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 trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Belgium
    Finland
    France
    Germany
    Italy
    New Zealand
    Sweden
    United Kingdom
    United States
    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
    The end of trial is defined as the last visit of the last patient undergoing the trial.
    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 months0
    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 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.1.1Number of subjects for this age range: 0
    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: 142
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 861
    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
    If the patient is not competent, a mentally-competent legally-acceptable representative must provide informed consent on his/her behalf, and the patient must provide verbal assent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 1050
    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)
    not applicable
    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 Decision2009-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-12
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