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    Summary
    EudraCT Number:2007-002627-32
    Sponsor's Protocol Code Number:2007-002627-32
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-09
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-002627-32
    A.3Full title of the trial
    A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis.
    A.4.1Sponsor's protocol code number2007-002627-32
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 nameFingolimod
    D.3.2Product code FTY720D
    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 INNFingolimod
    D.3.9.1CAS number 162359- 56-0
    D.3.9.2Current sponsor codeFTY720D
    D.3.9.3Other descriptive nameFTY720
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.25
    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 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 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
    Primary progressive multiple sclerosis.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10063401
    E.1.2Term Primary progressive multiple sclerosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of FTY720 relative to placebo on delaying the time to sustained disability progression.
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of FTY720 relative to placebo on delaying the time to 3-month sustained disability progression as measured by the EDSS.
    • To evaluate the effect of FTY720 relative to placebo on the time to 3-month sustained disability progression as measured by the 25’TWT.
    • To evaluate the effect of FTY720 relative to placebo on the time to 3-month sustained disability progression as measured by the 9-HPT.

    See other secondary objectives in the protocol (section 3.2)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Exploratory biomarker sub-studies on pharmacogenetics, pharmacogenomics, and additional exploratory biomarkers in blood and CSF are detailed in the enclosed protocol (section 7.6.4). These sub-studies are optional as only performed on patients who agree to participate by signing the separate exploratory biomarker/blood informed consent and the separate exploratory biomarker/CSF form.

    Please see enclosed protocol, Section 7.6.4, for further details.
    E.3Principal inclusion criteria
    General inclusion criteria:

    1. male or female
    2. 25 through 65 years of age inclusive
    3. females of childbearing potential must:
    • have a negative pregnancy test at Baseline (prior to randomization) and
    • use simultaneously two forms of effective contraception during the treatment and 3-months after discontinuation of study medication (refer to Section 7.5.9 for details)
    4. sign written informed consent prior to participating in the study

    Primary Progressive Multiple sclerosis / specific inclusion criteria :

    1. diagnosis of primary progressive multiple sclerosis (according to the 2005 Revised McDonald criteria, Appendix 8):
    • one year of disease progression plus
    • two of the following: a) positive brain MRI (nine T2 lesions or four or more T2 lesions with positive visual evoked potential), b) positive spinal cord MRI, c) positive CSF. Central review of the evidence will be required prior to randomization. Patients who meet all three criteria do not need to be submitted for central review.
    2. duration of disease at Baseline
    • time since first reported symptoms between 2 and 10 years
    3. documented evidence of clinical disability progression in the 2 years prior to Screening
    • clinical disability progression should have been observed in each of the previous 2 years prior to Screening as per clinical judgment of the investigator.
    • in addition, disability progression must be documented by an increase in the EDSS score of at least 0.5 points at any time point during the 2 years prior to Screening. Should documented EDSS scores not be available, a written summary of the clinical evidence of disability progression in the previous 2 years must be submitted for central review.
    4. disability status at Screening
    • EDSS score of 3.5-6.0 inclusive
    • pyramidal functional system score of 2 or more
    • 25’TWT less than 30 seconds
    E.4Principal exclusion criteria
    1. history of MS attack/relapse as per clinical judgement of the investigator
    2. progressive disabling neurological disorder, other than PPMS
    3. pure cerebellar progressive syndrome or pure visual progressive syndrome or a pure cognitive progressive syndrome
    4. presence of cervical spinal cord compression on Screening MRI
    5. relevant history of vitamin B12 deficit
    6. history of chronic active disease of the immune system other than MS which may require systemic immunosuppressive treatment or a known immunodeficiency syndrome
    7. history or presence of malignancy (except for successfully treated basal or squamous cell carcinoma of skin)
    8. known or ‘new’ diagnosis of diabetes mellitus (if Screening blood glucose is suspicious for diabetes [≥126 mg/dL or ≥7 mmol/L if fasting and ≥200 mg/dL or 11.1 mmol/L if random testing] a patient should be further evaluated for diabetes mellitus)
    9. diagnosis of macular edema during Pre-randomization Phase (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at the ophthalmic Screening visit)
    10. evidence of syphilis, borreliosis, HIV, Hepatitis B, Hepatitis C infection or any other active systemic bacterial, viral or fungal infections
    11. have received total lymphoid irradiation or bone marrow transplantation
    12. have been treated with:
    • systemic corticosteroids or adrenocorticotropic hormones (ACTH) within 3 months prior to randomization
    • interferon-beta (IFN-*) or glatiramer acetate within 3 months prior to randomization
    • immunosuppressive medications such as azathioprine or methotrexate within 6 months prior to randomization
    • immunoglobulins and/or monoclonal antibodies within 6 months prior to randomization
    • any mitoxantrone during previous 5 years prior to randomization or evidence of cardiotoxicity following mitoxantrone or mitoxantrone at a total cumulative life-time dose of more than 60 mg/m2
    • cladribine, cyclophosphamide at any time
    13. any medically unstable condition, as assessed by the primary treating physician
    14. any of the following cardiovascular conditions (see enclosed protocol section 5.2)
    15. any of the following pulmonary conditions (see enclosed protocol section 5.2)
    16. any of the following hepatic conditions (see enclosed protocol section 5.2)
    17. any of the following abnormal laboratory values (see enclosed protocol section 5.2)
    18. history of substance abuse (drug or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject’s ability to cooperate and comply with the study procedures
    19. unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA
    20. participation in any clinical research study evaluating another investigational drug or therapy within 6 months prior to randomization
    21. 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 laboratory test.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the time to sustained disability progression, which is defined based on three types of events for each subject:

    • 3-month sustained increase of at least 20% from Baseline in the 25’TWT or
    • 3-month sustained increase from Baseline in the EDSS score (1 point in patients with Baseline EDSS score 3.5 to 5.0; 0.5 point in patients with Baseline EDSS score of 5.5 or 6.0) or
    • 3-month sustained increase of at least 20% from Baseline in the 9-HPT in either one of the hands (dominant or non-dominant)

    Disability progression in this study can be achieved by the occurrence of any of three events for each subject (See enclosed protocol for further details, section 10.4.).
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Health-related quality of life and additional exploratory blood and LCR biomarkers.
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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) 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 650
    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)
    Patients who complete the study on study drug, may be offered access to FTY720, under a separate protocol, until the drug is available on the market for the treatment of PPMS or the development is discontinued.
    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 Decision2008-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-15
    P. End of Trial
    P.End of Trial StatusCompleted
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