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    Summary
    EudraCT Number:2009-012025-11
    Sponsor's Protocol Code Number:01373
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2009-11-30
    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 number2009-012025-11
    A.3Full title of the trial
    A double blind, randomized, placebo-controlled, parallel group,
    multicenter Phase 3 pivotal study to assess the safety and efficacy of
    1mg/kg/day intravenous DP-b99 over 4 consecutive days versus
    placebo when initiated within nine hours of acute ischemic stroke onset.
    A.3.2Name or abbreviated title of the trial where available
    MACSI
    A.4.1Sponsor's protocol code number01373
    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 SponsorD-Pharm Ltd.
    B.1.3.4CountryIsrael
    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 nameDP-b99, Lyophilized for Injection, 100mg/vial
    D.3.2Product code DP-b99
    D.3.4Pharmaceutical form Powder for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    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 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 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 Information not present in EudraCT
    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 placeboPowder for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Ischemic Stroke
    Stroke is the most common neurologic disorder and is the third leading
    cause of death in developed countries, after myocardial infarction and
    cancer. Stroke is the second leading cause of neurological morbidity in
    the United States, Europe, and Japan. 67%- 81% of all stroke cases are
    ischemic strokes.
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10055221
    E.1.2Term Ischemic stroke
    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
    The primary objective of this study is to compare the clinical therapeutic
    effects of intravenous DP-b99 at a dose of 1.0 mg/kg initiated within
    nine hours of stroke onset and administered daily over 2 hours for 4
    consecutive days versus placebo in subjects with moderately severe,
    likely hemispheric, acute ischemic stroke. The clinical outcome will be
    measured by the modified Rankin Scale at day 90.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to compare the safety and
    tolerability, as well as post-stroke recovery at Day 90, in subjects
    treated with DP-b99 versus placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    event, which must include at least one of the following components (as
    reflected by at least 1 point on any of the corresponding items of the
    NIHSS: 3, 9 or 11):
    - Visual
    - Best Language
    - Extinction and Inattention (formerly Neglect)
    3. Have suffered the onset of an acute ischemic stroke that can be
    evaluated and treatment initiated within 9 hours after the onset of acute
    was last seen in a normal state, or bedtime for unwitnessed strokes
    occurring during sleep.)
    4. Have at screening a NIHSS score of 10 to 16, inclusive
    5. Have readily accessible peripheral venous access for clinical trial
    material (CTM) administration and blood sampling
    6. Have the ability to understand the requirements of the study and be
    willing to provide written informed consent (IC) (as evidenced by
    signature on an informed consent document approved by an independent
    ethics committee (IEC), and agree to abide by the study restrictions and
    return for the required assessments. (In the event of incapacitated
    subjects, informed consent will be sought from a legally acceptable
    representative or by any other means as approved by the IRB or IEC).
    E.4Principal exclusion criteria
    1. Have an intracerebral or subarachnoid hemorrhage per
    screening/baseline computerized tomography (CT) scan or
    susceptibility-weighted magnetic resonance imaging (MRI)
    2. Be a candidate for either:
    a. thrombolytic therapy, or have been treated with thrombolytic therapy
    for the current stroke
    b. mechanical thromboembolectomy, or have been treated with
    mechanical thromboembolectomy for the current stroke
    3. Be delirious, comatose or stuporous (a score of ≥2 on item 1.a of the
    NIHSS) or demented, or having a mental impairment that in the
    investigator's opinion renders the subject incapable to participate in the
    study
    4. Have seizure(s) anytime from stroke onset to screening/baseline
    NIHSS evaluation
    5. Have neurological or non-neurological comorbidities that in the
    investigator's opinion may lead, independent of the current stroke, to
    further deterioration in the subject's neurological status during the trial
    period, or may render the study's neurological assessments inconclusive
    for the purpose of evaluating solely the stroke's effects (e.g., metabolic
    encephalopathies, hemiplegic migraine, multiple sclerosis, central
    nervous system tumor, convulsive disorder, monocular blindness)
    6. Be likely to undergo a procedure involving cardiopulmonary bypass
    during the study period
    7. Have suffered a myocardial infarction in the last 90 days
    8. Have any medical condition that in the investigator's opinion may
    threaten the subject's ability to complete the study (e.g., concurrent
    significant or life-threatening diseases, such as malignancies or end
    stage organ failure)
    9. Have rapid spontaneous improvement of neurological signs during
    screening/baseline assessments
    10. Have premorbid neurological deficits and functional limitations
    assessed by a pre-stroke Modified Rankin Scale score of > 1
    11. Have suffered a stroke within 90 days of the screening/baseline
    assessments that is either diagnostically confirmed or assumed to be in
    the same cerebral territory as is the current acute stroke
    12. Have either severe hypertension (systolic blood pressure (BP) >220
    mm Hg or diastolic BP >120 mm Hg) or hypotension (systolic BP <90
    mm Hg), as measured by at least 2 consecutive supine measurements
    taken 10 minutes apart prior to randomization.
    13. Have significant current renal or hepatic disease(s): a serum
    creatinine concentration of >2.5 mg/dL; alanine aminotransferase (ALT),
    aspartate aminotransferase (AST), or gamma-glutamyl transferase
    (GGT) values that are three times greater than the upper limit of normal
    (ULN) (or, if GGT cannot be evaluated, direct bilirubin must not be
    greater than 1.5 times the ULN).
    14. Have a platelet count of <100,000/mm3 or for patients on oral
    anticoagulants at study entry, INR of >4
    15. Be a female of childbearing potential (less than 2 years'
    postmenopausal or not surgically sterilized) who is not willing to use
    adequate and effective birth control measures for the duration of the
    trial. Effective birth control measures include hormonal contraception, a
    barrier method such as a diaphragm, intrauterine device (IUD) and/or
    condom with spermicide (IUD, diaphragm, condoms alone or the rhythm
    method are not considered reliable methods)
    16. Have a positive urine pregnancy test at screening/baseline or be a
    lactating female
    17. Be currently dependent on, or abusing, alcohol or one or more of the
    following: sympathomimetic amines (amphetamine-like), cannabis,
    cocaine, hallucinogens, inhalants, opioids, phencyclidine, sedatives and
    hypnotics
    18. Have received an investigational drug or product or participated in
    an investigational drug study within a period of 30 days prior to
    receiving study medication or have previously participated in a clinical
    trial involving DP-b99
    19. Have severe anemia as measured by a hemoglobin value of < 7 g/dl.
    20. Being in a dependent relationship with the physician or the study
    21. Known hypersensitivity to any component of the investigational
    product
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the mRS score at 90 days (or on last
    rating) following stroke onset as analyzed across the whole distribution
    of scores ("shift analysis").
    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) 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.8.3 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 EEA50
    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
    End of the trial will be when a total of 770 subjects have been
    randomized.
    Since this study is monitored by a data safety monitoring board
    (DSMB), this board may stop the trial early for the following reasons:
    A. Exposure to DP-b99 proves to be unsafe after weighing the
    predetermined
    safety factors as detailed in the DSMB charter
    or
    B. The futility analysis reached its pre-specified futility threshold
    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 months5
    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 months5
    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 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Due to the acute ischemic stroke symptoms some patients might not be
    able to give their consent personally. In such case the informed
    consent will be sought from a legally acceptable representative or by
    any other means as approved by the IEC.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 770
    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)
    Subjects will be entitled to the normal care, all follow-up plans are
    detailed in the protocol.
    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 Decision2010-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-21
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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