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    Summary
    EudraCT Number:2014-000395-26
    Sponsor's Protocol Code Number:GER-BGT-13-10586
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-04-09
    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 number2014-000395-26
    A.3Full title of the trial
    A 3-year open-label, exploratory, single arm study to describe long term changes in the visual system of patients with relapsing remitting multiple sclerosis (RRMS) on oral dimethyl fumarate
    Eine 3-jährige, offene, explorative, einarmige Studie zur Untersuchung von Langzeitveränderungen im visuellen System bei Patienten mit schubförmiger remittierender multipler Sklerose (RRMS) unter oraler Dimethylfumaratbehandlung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Description ofchanges in that part of the nervous sstem that is processing visual information over an extended perion of time in patients with relapsing remitting multiple sclerosis who take Tecfidera
    Beschreibung von Veränderungen in dem Teil des Nervensystems, das visuelle Informationen verarbeitet über einen längerfristigen Zeitraum bei Patienten mit schubförmig verlaufender Multipler Sklerosie, die Tecfidera einnehmen
    A.3.2Name or abbreviated title of the trial where available
    VISION
    A.4.1Sponsor's protocol code numberGER-BGT-13-10586
    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 GmbH
    B.1.3.4CountryGermany
    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 GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen GmbH
    B.5.2Functional name of contact pointMedical Affairs Manager Neurology
    B.5.3 Address:
    B.5.3.1Street AddressCarl-Zeiss-Ring 6
    B.5.3.2Town/ cityIsmaning
    B.5.3.3Post code85737
    B.5.3.4CountryGermany
    B.5.6E-mailnatalie.seegers@biogen.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 Yes
    D.2.1.1.1Trade name Tecfidera
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec Ltd
    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.3.4Pharmaceutical form 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.3.9.3Other 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 number240
    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 (RRMS)
    schubförmige remittierende multiple Sklerose
    E.1.1.1Medical condition in easily understood language
    Relapsing remitting multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system, which progresses in single relapses.
    Schubförmig remittierende Multiple Sklerose (MS) ist eine chronisch-entzündliche Erkrankung des zentralen Nervensystems, welche in einzelnen Schüben verläuft.
    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 18.0
    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
    Evaluation of changes of the visual sysetm in RRMS patients treated with dimethyl fumarate assessed by RNFL thickness measured by OCT over 36 months
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed.
    2. Male or female subjects aged 18-64 years.
    3. Subjects with a) relapsing remitting MS (RRMS) defined by 2010 revised McDonald (Polman et al., 2011) criteria OR b) early MS (100 patients, reference cohort)
    a) Patients with diagnosis of RRMS must satisfy the approved therapeutic indication for dimethyl fumarate (DMF) (as per local SmPC) and must have been clinically stable on DMF for at least 4 and up to 16 weeks prior to screening visit
    b) Patients in the reference cohort must have had a single neurological episode within 60 months before screening.
    They have to be without immunomodulatory treatment at screening.
    They must not have a progressive form of MS.
    Patients for the reference cohort may be evaluated also retrospectively at selected sites if they have given full informed consent.
    The following data have to be recorded or available for these reference patients:
    - Demography
    - Neurological examination / EDSS
    - OCT
    - Visual acuity (BCVA)

    4. Patients with Expanded Disability Status Scale (EDSS) score of 0-5.5 (including).
    5. RNFLT at screening (for RRMS patients) must be at least 84µm and high contrast ETDRS visal acuity >0.5 in at least one eye (OCT has to be confirmed by Central Reading Center). For reference patients criteria have to be fulfilled at time of first documented OCT measurement.
    E.4Principal exclusion criteria
    1. Patients that are unwilling or unable to comply with study requirements, or are deemed unsuitable for study participation as determined by the Investigator.
    2. Patients that have major comorbid conditions that preclude participation in the study, as determined by the Investigator.
    3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test (urine dipstick).
    4. Women of childbearing potential and not using appropriate contraception (per local DMF SmPC) as determined by the Investigator.
    5. Patients with known hypersensitivity to the active ingredient in the DMF drug product or to any of the excipients listed in the local DMF SmPC (for the RRMS cohort).
    6. Patients with a contraindication to DMF according to SmPC (for the RRMS cohort)
    7. Patients with an onset of acute optic neuritis within the last 3 months.
    8. Patients with an MS relapse within the last 30 days
    9. Concomitant use of drugs that may directly affect retinal structure and function (e.g. chronic systemic corticosteroids).
    10. Patients with any ophthalmologic reason for RNFL pathology other than MS, such as: optic neuropathy, active advanced glaucoma, injury of the optic nerve based on the ophthalmologist’s clinical judgment.
    11. Patients with evidence of advanced, non-proliferative or proliferative diabetic retinopathy.
    12. Patients with presence of retinal conditions associated with edema, subretinal fluid, cysts, etc.
    13. Patients with history or presence of severe myopia (> - 6 dpt).
    14. Patients who participate in another interventional study.
    15. Patients who are institutionalized by court or official order
    E.5 End points
    E.5.1Primary end point(s)
    Parameters of interest

    -Ganglion cell and inner plexiform layer (GCIPL) thickness as measured by OCT at Baseline, months 12, 24, and 36
    -Retinal nerve fiber layer thickness (RNFLT) as measured by OCT at Baseline, months 12, 24, and 36
    -Optic nerve head volume (ONH-V) as measured by OCT at Baseline, months 12, 24, and 36
    -Visual acuity (ETDRS, Landolt and Sloan charts) at Baseline, months 12, 24, and 36
    -Visual quality of life (NEI-VFQ-25) at Baseline, months 12, 24, and 36
    -EDSS at Baseline and months 12, 24 and 36
    -Annual relapse rate (ARR) over 36 months
    -AEs and SAEs over 36 months
    -Central visual field as measured by perimetry at Baseline, months 12, 24, and 36
    -Inner nuclear layer (INL) thickness as measured by OCT at Screening, Baseline, months 12, 24, and 36
    -QoL (PRIMuS) at Baseline, months 12, 24 and 36
    -Disability Progression (MSFC) at Baseline, months 12, 24 and 36
    -Cognition (SDMT) at Baseline, months 12, 24 and 36
    E.5.1.1Timepoint(s) of evaluation of this end point
    12, 24, 36 months
    E.5.2Secondary end point(s)
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    EDSS, MSFC, SDMT and Sloan chart measurements
    E.8.2.4Number of treatment arms in the trial2
    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 concerned20
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    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 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.1.2.1Number of subjects for this age range: 600
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state600
    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)
    DMF is an approved treatment in the European Union, and continuing treatment with DMF after end of trial via prescription or commercial sources will be left to the discretion of the subject and Investigator
    DMF ist eine zugelassene Behandlung in der Europäischen Union; die Entscheidung über das Fortsetzen der Behandlung mit DMF als verschreibungspflichtiges Medikament nach Studienabschluss wird nach Ermessen des Arztes und Wunsch des Patienten fortgeführt oder nicht
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-10-31
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