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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2014-005003-24
    Sponsor's Protocol Code Number:109MS202
    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:2015-02-25
    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 number2014-005003-24
    A.3Full title of the trial
    Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis'
    A.4.1Sponsor's protocol code number109MS202
    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 SponsorBiogen Idec Research Limited
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointClinical Trials - Neurology
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailneurologyclinicaltrials@biogenidec.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 nameBG00012
    D.3.4Pharmaceutical form Gastro-resistant capsule, hard
    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 INNDIMETHYL FUMARATE
    D.3.9.1CAS number 624-49-7
    D.3.9.2Current sponsor codeBG00012
    D.3.9.3Other descriptive nameDIMETHYL FUMARATE
    D.3.9.4EV Substance CodeSUB13608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing-Remitting Multiple Sclerosis
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    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 19.0
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    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 evaluate the effect of BG00012 on brain MRI lesions in paediatric subjects with RRMS
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are as follows:
    - To characterize the PK of BG00012 in paediatric subjects with RRMS
    - To evaluate the safety and tolerability of BG00012 in paediatric subjects with RRMS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in this study, candidates must meet the following eligibility criteria at Screening or at the timepoint specified in the individual eligibility criterion listed:

    1. Ability of parents or legal guardians to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parent or legal guardian, as appropriate, as per local regulations.

    2. Male and female subjects aged 10 to 17 years old, inclusive, at the time of informed consent.

    3. Must have a body weight of ≥30 kg at Screening and Day 1.

    4. Must have a diagnosis of RRMS according to McDonald criteria for MS (2010) [Polman 2011] and International Pediatric Multiple Sclerosis Study Group criteria for pediatric MS (2013) [Krupp 2013].

    5. Must be ambulatory, with a converted Kurtzke baseline EDSS score between 0 and 5.0, inclusive.

    6. Must have experienced ≥1 relapse in the 12 months prior to Screening or ≥2 relapses in the 24 months prior to Screening.

    7. Must agree to be without treatment for 8 weeks prior to Day 1.

    8. Sexually active subjects of reproductive potential must practice effective contraception during the study and for at least 30 days after their last dose of study treatment. For further details of contraceptive requirements for this study, refer to the protocol.
    E.4Principal exclusion criteria
    Candidates will be excluded from study entry if any of the following exclusion criteria exist at Screening or at the timepoint specified in the individual criterion listed:

    1. Primary progressive, secondary progressive, or progressive relapsing MS (as defined by [Lublin and Reingold 1996]). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Subjects with these conditions may also have superimposed relapses but are distinguished from relapsing-remitting subjects by the lack of clinically stable periods or clinical improvement.

    2. Disorders mimicking MS, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease, lupus erythematosus, and neuromyelitis optica), metabolic disorders (e.g., dystrophies), and infectious disorders.

    3. History of premalignant or malignant disease. Subjects with basal cell carcinoma that has been completely excised prior to Screening will remain eligible.

    4. History of severe allergic or anaphylactic reactions or known drug hypersensitivity to DMF or fumaric acid esters.

    5. History of any clinically significant cardiovascular, dermatologic, endocrinologic, GI, hematologic, immunologic, growth, developmental, pulmonary, psychiatric, neurologic (other than MS), renal, urologic, and/or other major disease that may confound safety or efficacy assessment.

    6. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to Screening.

    7. Any of the following abnormal blood tests at Screening:
    - alanine transaminase (ALT)/serum glutamic pyruvic transaminase (SGPT), AST/serum glutamic oxaloacetic transaminase (SGOT), or gamma glutamyl transferase (GGT) ≥2 times the upper limit of normal
    - leukocytes <3500/mm3
    - absolute lymphocyte count <LLN
    - eosinophils >0.7 × 103/μL or >0.7 GI/L

    8. Any of the following abnormal urine tests at Screening confirmed by a second urinalysis 2 weeks later:
    - proteinuria (1+ or greater) and/or spot protein/creatinine ratio (with AM void) >0.2 mg. Note: Documented benign proteinuria is not exclusionary.
    - hematuria, without known etiology (e.g., urinary tract infection or menses)
    - glycosuria, without known etiology (e.g., recent steroid use or elevated serum glucose)

    9. History of or positive test result at Screening for human immunodeficiency virus.

    10. History or positive test result at Screening for hepatitis C virus antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]). Subjects with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive hepatitis B surface antibody immunoglobulin G, and positive HBcAb) are eligible to participate in the study (US Centers for Disease Control and Prevention’s interpretation of the hepatitis B serology panel) [CDC 2007].

    Treatment History
    11. Any previous treatment with Fumaderm® or BG00012.

    12. Prior treatment with any of the following:
    - total lymphoid irradiation
    - cladribine
    - T-cell or T-cell receptor vaccination
    - any therapeutic monoclonal antibody, with the exception of rituximab or natalizumab

    13. Prior treatment with any of the following medications within the 12 months prior to the Week -8 MRI:
    - mitoxantrone
    - cyclophosphamide
    - rituximab

    14. Prior treatment with any of the following medications or procedures within 6 months prior to the Week -8 MRI:
    - fingolimod
    - teriflunomide
    - natalizumab
    - cyclosporine
    - azathioprine
    - methotrexate
    - mycophenolate mofetil
    - laquinimod
    - intravenous (IV) immunoglobulin
    - plasmapheresis or cytapheresis

    15. Prior treatment with any of the following within 28 days prior to the Week -8 MRI:
    - glatiramer acetate
    - interferon-β
    - steroids (IV or oral corticosteroid treatment, including agents that may act through the corticosteroid pathway [e.g., low-dose naltrexone])

    Miscellaneous
    16. Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 6 months prior to Day 1.

    17. Female subjects considering becoming pregnant or breastfeeding while in the study or who are pregnant or breastfeeding.

    18. Subjects for whom MRI was contraindicated, e.g., who had pacemakers or other contraindicated implanted metal devices or had claustrophobia that could not be medically managed.

    19. Inability to comply with study requirements.

    20. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline Period to On-Treatment Assessment Period in the number of new or newly enlarging T2 hyperintense lesions on brain MRI scans, where the Baseline Period is from Week -8 to Day 0 and the On-Treatment Assessment Period is from Week 16 to Week 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline period (Week -8 to Day 0), weeks 16 & 24
    E.5.2Secondary end point(s)
    The secondary endpoints of this study are as follows:
    - PK parameters: Cmax, time to reach maximum observed plasma concentration (Tmax), apparent clearance (CL/F), apparent volume of distribution (V/F), elimination half-life (t½), and area under the concentration-time curve from time 0 to infinity (AUC0-inf)

    - Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK Assessments:
    Day 1 (within 2 hrs prior to dose, 2 hrs post-dose, 3 hrs post-dose).
    Day 8 (within 2 hrs prior to dose, 30 mins post-dose and 1, 2, 3, 4, 5, 6, 8, 10 hrs post-dose).

    AEs and SAEs:
    For AEs monitoring is from Week -8 MRI Visit up to the Safety Follow-Up Visit, or from the Week -8 MRI Visit up to the Week 24 Visit for subjects enrolling in the extension study.

    For SAEs monitoring is from the signing of ICF and assent up to the Safety Follow-Up Visit, or from the signing the ICF up to the Week 24 Visit for subjects enrolling in the extension study. Any SAE that is ongoing when the subject completes or discontinues the study will be followed by the Investigator until the event has resolved, stabilized, or returned to baseline status
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Bulgaria
    Czech Republic
    Finland
    France
    Germany
    Israel
    Italy
    Kuwait
    Latvia
    Lebanon
    Lithuania
    Poland
    Turkey
    United Kingdom
    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
    LVLS: The end of study is last subject, last visit
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    F.1.1Number of subjects for this age range: 18
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 4
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 14
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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
    Minors are enrolled in this study.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 11
    F.4.2.2In the whole clinical trial 18
    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 may have an option of entering a long-term extension study. Patients who choose not to enroll in the extension study will have a Safety Follow-Up Visit 4 weeks after taking the final dose of study treatment. Subjects who withdraw prematurely will complete the Early Withdrawal Visit no later than 1 week after their last dose of study treatment and the Safety Follow-Up Visit 4 weeks after taking their final dose.
    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 Decision2015-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-23
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