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    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2004-000663-99
    Sponsor's Protocol Code Number:C-1900
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-09-08
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2004-000663-99
    A.3Full title of the trial
    Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis.
    A.4.1Sponsor's protocol code numberC-1900
    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 SponsorBiogen Idec 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
    B.Sponsor: 2
    B.1.1Name of SponsorBiogen Idec Ltd
    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 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 Information not present in EudraCT
    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 namesecond-generation fumaric acid
    D.3.2Product code BG00012
    D.3.4Pharmaceutical form Capsule, hard
    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 INNdimethyl fumarate
    D.3.9.1CAS number 62008-21
    D.3.9.2Current sponsor codedimethyl fumarate
    D.3.9.3Other descriptive namedimethyl fumarate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboCapsule, hard
    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
    MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years.
    MedDRA Classification
    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 determine the efficacy of three dose levels of BG00012 on brain lesion activity as measured by MRI in subjects with relapsing-remitting MS when compared to placebo.
    E.2.2Secondary objectives of the trial
    Additional study objectives are to determine:
    - the number of T1 hypointense lesions at Week 24 compared to baseline
    - the safety and tolerability of BG00012 in subjects with MS
    - the efficacy of BG00012 in MS on disability progression as measured by EDSS, and
    - the efficacy of BG00012 in reducing the number of relapses based on annualized relapse rate and proportion of relapse-free subjects.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Must give written informed consent and authorize the release and use of protected health information (PHI), as required by local law.

    2.Must be 18 to 55 years old, inclusive, at the time of informed consent.

    3.Must have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 (McDonald et al, 2001; Appendix 2).

    4.Must have a baseline EDSS between 0.0 and 5.0, inclusive.

    5.Must meet one of the following criteria:

    - Must have experienced at least one relapse within the 12 months prior to randomization, with a prior cranial MRI demonstrating lesion(s) consistent with MS (it is not necessary to obtain a current scan if a scan performed previously is available from the subject’s history; if a scan is not available from the subject’s history, then the baseline scan may be used). For inclusion purposes, a relapse is defined as neurologic signs and/or symptoms documented by a neurologist in the medical record and of at least 24-hours duration to be determined by the investigator or the treating neurologist. Time since relapse should be measured from the time of relapse onset, OR.
    - show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization (if a scan is not available from the subject's history, then the baseline scan may be used).


    6.Male and female subjects must be willing to take appropriate measures to prevent pregnancy while participating in this study. Male subjects and female subjects of child-bearing potential must use adequate contraception as appropriate (either intra-uterine device, oral or depot contraceptive, or barrier plus spermicide) and be willing and able to continue contraception for 30 days after their last dose of investigational drug. The rhythm method is not to be used as the sole method of contraception. Females who have not been stable on oral or depot contraceptives for 3 months prior to the first dose of investigational drug must also agree to use a barrier method throughout the study. Female subjects are exempt from contraceptive use if they are post-menopausal for at least 1 year prior to the start of the study or are surgically sterile (females need to have either no uterus or no ovaries to be considered surgically sterile; males or females who have tubes tied or cut are not considered surgically sterile).

    All female subjects who are not post-menopausal or surgically sterile must have a negative pregnancy test at screening and at various time points throughout the study to receive investigational drug.
    E.4Principal exclusion criteria
    Medical History

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

    2.History of malignancy unless an exception is granted by the Biogen Idec Medical Director.

    3.History of severe allergic or anaphylactic reactions or known drug hypersensitivity.

    4.History of abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than MS), and/or other major disease that would preclude administration of BG00012.

    5.History of human immunodeficiency virus (HIV).

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

    7.An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.

    8.Body weight >100 kg.

    9.Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.

    10.Any of the following abnormal blood tests at screening:
    - alanine transaminate/serum glutamate-pyruvate transaminase (AST/SGPT), or aspartate transaminase/serum glutamic-oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase (GGT) >2 times the upper limit of normal (ULN)
    - leukocytes <3500/mm3
    - eosinophils >10% of the total leukocyte count, and
    - serum creatinine >ULN.

    Treatment History

    11.Any previous treatment with FUMADERM®, FAG-201 or BG00012.

    12.Prior treatment with the any of the following:
    - total lymphoid irradiation
    - cladribine
    - T-cell or T-cell receptor vaccination
    - any therapeutic monoclonal antibody, with the exception of ANTEGREN® (natalizumab) (see exclusion #14)


    13.Prior treatment with any of the following within 1 year prior to randomization:
    - mitoxantrone
    - cyclophosphamide

    14.Prior treatment with any of the following medications or procedures within the 6 months prior to randomization:
    - cyclosporine
    - azathioprine
    - methotrexate
    - natalizumab
    - intravenous immunoglobulin (IVIg)
    - plasmapheresis or cytapheresis.

    15.Prior treatment with any of the following within the 3 months prior to randomization:
    - subcutaneous or oral glatiramer acetate
    - interferon-alpha
    - interferon-beta (subjects who are positive for neutralizing antibodies to interferon beta may receive interferon-beta treatment up to 2 weeks prior to randomization).

    16.Treatment with any of the following medications within the 30 days prior to randomization:
    - IV corticosteroid treatment
    - oral corticosteroid treatment
    - 4-aminopyridine or related products.

    17.Treatment with another investigational drug or approved therapy for investigational use within the 6 months prior to randomization.

    Miscellaneous

    18.Female subjects considering becoming pregnant while in the study.

    19.Female subjects who are currently pregnant or breast-feeding.

    20.Previous participation in this study.

    21.Current enrollment in any other investigational drug study or participation in any other investigational study within 6 months prior to randomization.

    22.Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s ability to comply with the protocol.

    23.Any other reasons that, in the opinion of the Investigator and/or the Sponsor, the subject is determined to be unsuitable for enrollment in this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the total number of Gd-enhancing lesions over four scans at Weeks 12,16,20 and 24 (calculated as the sum of these four MRI scans).
    Secondary MRI endpoints include:
    - the cumulative number of new Gd-enhancing lesions from baseline to Week 24, and
    - the number of new or newly enlarging T2 hyperintense lesions at Week 24 compared to baseline.
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 Yes
    E.8.1.7.1Other trial design description
    extension phase is "open"
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Last patient out.
    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 months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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) 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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 186
    F.4.2.2In the whole clinical trial 260
    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 Decision2004-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-03-31
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