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    Summary
    EudraCT Number:2007-003362-17
    Sponsor's Protocol Code Number:MPC-7869-05-009.02
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-11-14
    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 number2007-003362-17
    A.3Full title of the trial
    Open Label Study of the Effect of Daily Treatment with MPC-7869 in Subjects with
    Dementia of the Alzheimer’s Type
    A.4.1Sponsor's protocol code numberMPC-7869-05-009.02
    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 SponsorMyriad 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 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 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 nameTarenflurbil
    D.3.2Product code MPC-7869
    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 INNTarenflurbil
    D.3.9.1CAS number 51543-40-9
    D.3.9.2Current sponsor codeMPC-7869
    D.3.9.3Other descriptive name(R)-(-)-flurbiprofen
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    Treatment of Alzheimer’s disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety of long term treatment with MPC-7869
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria during screening in order to
    participate in the study:
    1. Completed, without protocol violations, a Myriad Pharmaceuticals, Inc MPC-7869
    clinical trial for Alzheimer’s Disease.
    OR
    Discontinued from the Phase 3 trial, MPC-7869-04-005, solely due to MMSE
    score ≤19.
    OR
    Were scheduled for screening prior to cessation of enrollment for MPC-7869-05-
    010 and continues to meet all applicable inclusion/exclusion criteria for MPC-
    7869-05-010,

    Subjects who were scheduled for screening for the MPC-7869-05-010 study
    must also meet the following criteria:
    a. Have had a diagnosis of dementia according to the Diagnostic
    and Statistical Manual of Mental Disorders – Fourth Edition (text
    revised) (DSM IV [TR]), as described in Appendix B, and meet
    the National Institute of Neurological and Communicative
    Disorders and Stroke and the Alzheimer’s Disease and Related
    Disorders Association (NINCDS-ADRDA) criteria for probable
    Alzheimer’s disease, as described in Appendix C.
    b. Have a computed tomography (CT) or magnetic resonance
    imaging (MRI) within the past 12 months, demonstrating
    absence of clinically significant focal intracranial pathology. If no
    scan is available in the previous 12 months, then a CT or MRI
    scan will be obtained.
    c. Have a screening MMSE score ≥ 20 and ≤ 26.
    d. Have a screening Modified Hachinski Ischaemic score < 4.
    e. Men or women ages ≥ 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
    f. Female subjects must be surgically sterile or postmenopausal for > 1 year.
    2. Signed the subject Informed Consent Form (ICF) and is willing and able to
    participate in the study.
    3. Chronic aspirin use will be limited to cardioprotective therapy (eg, ≤325 mg
    aspirin per day) for the duration of the study.
    4. Must have a reliable caregiver.
    E.4Principal exclusion criteria
    Subjects with any of the following exclusion criteria may not participate in the study:
    1. Current evidence or history in the past 2 years of epilepsy, focal brain lesion,
    head injury with loss of consciousness and/or immediate confusion after the
    injuries, or DSM-IV (TR) criteria for any major psychiatric disorder including
    psychosis, major depression, bipolar disorder, alcohol or substance abuse.
    2. History of hypersensitivity to flurbiprofen or other NSAIDs including COX-2
    specific inhibitors.
    3. Chronic use of NSAIDs at any dose or aspirin >325 mg per day, taken on more
    than 7 days per month.
    4. History of upper GI bleeding requiring surgery and/or transfusion within the past
    3 years.
    5. Documented evidence of active gastric or duodenal ulcer disease within the past
    3 months.
    6. History of NSAID associated ulcers.
    7. Chronic or acute renal, hepatic or metabolic disorder defined by:
    1. Creatinine > 1.5 mg/dL
    A. For Creatinine greater than 1.5 mg/dL a Creatinine
    clearance should be within normal limits.
    2. AST > 2.5 x Upper Limit of Normal (ULN)
    3. ALT > 2.5 x ULN
    8. Uncontrolled cardiac conditions (New York Heart Association Class III or IV, as
    described in Appendix D).
    9. Treatment with any CYP2C9 inhibitor within a 2-week period prior to enrollment.
    The following drugs and herbal preparations are examples of CYP2C9 inhibitors:
    amiodarone, fluconazole, fluvoxamine, isoniazid, phenylbutazone, probenicid,
    sulfamethoxazole, sulfaphenazole, trimethoprim, zafirlukast; danshen (Salvia
    miltiorrhiza); Lycium barbarum.
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints include incidence of adverse events (AEs), changes in physical examinations, and clinical laboratory test results.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months
    E.8.9.1In the Member State concerned days
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 316
    F.4.2.2In the whole clinical trial 850
    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)
    One purpose of the study is to provide study drug to patients until study drug will be registered and has received marketing approval. So one option for patients at the end of the study will be to continue treatment with the study drug, the usage of alternative medication is also possible and depends on the judgement of treating physicians.
    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 Decision2008-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-24
    P. End of Trial
    P.End of Trial StatusOngoing
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