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    Summary
    EudraCT Number:2009-013841-27
    Sponsor's Protocol Code Number:160604
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-27
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2009-013841-27
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy
    A.3.2Name or abbreviated title of the trial where available
    IGIV, 10% MMN Trial
    A.4.1Sponsor's protocol code number160604
    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 SponsorBaxter Innovations GmbH
    B.1.3.4CountryAustria
    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 KIOVIG 100 mg/ml solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter AG
    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 nameIGIV, 10%
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 0
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN (IV)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution 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
    Multifocal motor neuropathy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10065579
    E.1.2Term Multifocal motor neuropathy
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy (effect on grip strength and disability) and safety/tolerability of IGIV, 10% in subjects with multifocal motor neuropathy (MMN).
    E.2.2Secondary objectives of the trial
    Evaluation of additional efficacy measures for MMN.
    Additional safety analysis and categorization of adverse events.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained from the subject prior to any study-related
    procedures and study product administration.
    2. Diagnosis of definite or probable MMN based on the criteria of the American
    Association of Electrodiagnostic Medicine.
    Conduction block can be defined by a drop in amplitude. Diagnosis can be based
    on chart records
    a. Hand grip (finger flexor) weakness of Medical Research Council (MRC) grade 4
    or less or equivalent, at disease onset or appearing prior to screening.
    b. No upper motor signs.
    c. No bulbar or cranial signs or symptoms.
    d. No clinically identifiable sensory abnormalities.
    3. Must be on a stable regimen of IGIV for at least 3 months prior to enrollment.
    4. Treatment interval with IGIV of 2 to 5 weeks (+/- 3 days).
    5. Dose of IGIV to be 0.4 to 2.0 g per kg bodyweight (BW) and infusion cycle.
    6. Subjects are adults, male of female, at least 18 years of age.
    7. If female and capable of bearing children - have a negative urine pregnancy test
    result at enrollment and agree to employ adequate birth control measures for the
    duration of the study.
    E.4Principal exclusion criteria
    1. Any clinical or electrophysiological evidence of coexisting neuropathy which may
    interfere with outcome assessments, such as diabetic neuropathy, toxic
    neuropathy, or neuropathy due to systemic lupus erythematosis.
    2. Treatment with other immunosuppressive agents besides IGIV, which have
    demonstrated efficacy in MMN such as cyclophosphamide during the 3 months
    prior to enrollment (or treatment with Rituximab during the 12 months prior to
    enrollment). Pre-study treatment with mycophenolate mofetil or azathioprine is
    permitted if the dose has been stable for 3 months prior to enrollment.
    3. Cerebrospinal fluid protein > 100 mg/dL (if done as part of a previous
    evaluation).
    4. Subjects positive at enrollment for Hepatitis B surface antigen, PCR for HCV,
    and/or PCR for HIV Type 1.
    5. Subjects with levels of alanine aminotransferase (ALT) or aspartate
    aminotransferase (ASP) > 2.5 times the upper limit of normal.
    6. Subjects with neutropenia (defined as an absolute neutrophil count [ANC]
    <= 1000/mm³)
    7. Subjects with serum creatinine levels greater than 1.5 times the upper limit of
    normal.
    8. Subjects with malignancy other than adequately treated basal cell or squameous
    cell carcinoma of the skin or carcinoma in situ of the cervix.
    9. Subjects with a history of thrombotic episodes (deep vein thrombosis, myocardial
    infarction, cerebrovascular accident).
    10. Subjects with an ongoing hypersensitivity or persistent reactions (urticaria,
    breathing difficulty, severe hypotension, or anaphylaxis) following IGIV.
    11. Subjects with immunoglobulin A deficiency and known anti-IgA antibodies.
    12. If female, is pregnant or lactating at time of enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoints:
    - Grip strength in the more affected hand.
    - Upper limb (Part 6) subsection of the Guy's Neurological Disability Score (GNDS).

    Primary safety endpoints include:
    - The rate of temporally associated adverse events (AEs) per infusion, defined as the
    total number of all AEs that begin during infusion or within 72 hours of completion
    of an infusion, irrespective of being related or not related to the study product,
    divided by the total number of infusions.
    - The proportion of subjects for whom the infusion rate for any infusion was reduced
    and/or the infusion was interrupted or stopped for any reason.
    - The proportion of subjects reporting one ore more moderate or severe AEs
    that begin during infusion or within 72 hours of completion of an infusion.
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Stabilization Phase 1 to 3 open, Cross-over Period 1 and 2 double-blind.
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 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
    Study termination 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 years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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.1.1.1In 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 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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 40
    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)
    All patients will be on a stable regimen of IGIV for at least 3 months before entering the trial, and will also continue with their treatment after the completion of the trial as prescribed by the investigator.
    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 Decision2009-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-11
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