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    Summary
    EudraCT Number:2007-002627-32
    Sponsor's Protocol Code Number:CFTY720D2306
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-16
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-002627-32
    A.3Full title of the trial
    A double-blind, randomized, multicenter, placebocontrolled, 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.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberCFTY720D2306
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 FARMA
    B.1.3.4CountryItaly
    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.3.9.2Current sponsor codeFTY720D
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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. Sustained disability progression is defined based on three types of events for each subject: 3-month sustained increase of at least 20% from Baseline in the timed 25-foot walk test (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-hole peg test (9-HPT)
    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 Other secondary objectives To evaluate the safety and tolerability of FTY720 compared to placebo in patients with PPMS To evaluate the effect of FTY720 relative to placebo on conventional MRI parameters (inflammatory disease activity, disease burden, brain atrophy) To evaluate the effect of FTY720 relative to placebo on patient reported outcomes To assess the pharmacokinetics of FTY720 and FTY720-P in patients with PPMS and evaluate the pharmacokinetic/pharmacodynamic relationship for main efficacy and safety outcomes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who meet all of the following inclusion criteria during the Pre-Randomization Phase will be eligible for enrollment in the study: General male or female 25 through 65 years of age inclusive females of childbearing potential must have a negative pregnancy test at Baseline and use simultaneously two forms of effective contraception during the treatment and 3 months after discontinuation of study medication sign written informed consent prior to participating in the study Primary Progressive Multiple Sclerosis diagnosis of primary progressive multiple sclerosis (according to the 2005 Revised McDonald criteria): - 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 (two focal T2 lesions), 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. duration of disease at Baseline - time since first reported symptoms between 2 and 10 years 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. 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
    Patients who meet any of the following exclusion criteria during the Pre-Randomization Phase will not be eligible for enrollment in the study: history of MS attack/relapse as per clinical judgement of the investigator progressive disabling neurological disorder, other than PPMS pure cerebellar progressive syndrome or pure visual progressive syndrome or a pure cognitive progressive syndrome. presence of cervical spinal cord compression on Screening MRI relevant history of vitamin B12 deficit history of chronic active disease of the immune system other than MS which may require systemic immunosuppressive treatment or a known immunodeficiency syndrome history or presence of malignancy (except for successfully treated basal or squamous cell carcinoma of skin) known or ‘new’ diagnosis of diabetes mellitus (if Screening blood glucose is suspicious for diabetes [&#8805;126 mg/dL or &#8805;7 mmol/L if fasting and &#8805;200 mg/dL or 11.1 mmol/L if random testing] a patient should be further evaluated for diabetes mellitus) 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) active systemic bacterial, viral or fungal infections, or diagnosis of syphilis, borreliosis, HIV, Hepatitis B, Hepatitis C infection or any other active systemic bacterial, viral or fungal infections have received total lymphoid irradiation or bone marrow transplantation have been treated with: - systemic corticosteroids or adrenocorticotropic hormones (ACTH) within 3 months prior to randomization - IFN-&#946; 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 less than 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 any medically unstable condition, as assessed by the primary treating physician any of the following cardiovascular conditions: - myocardial infarction within the past 6 months prior to enrollment or current unstable ischemic heart disease - history of angina pectoris due to coronary spasm or history of Raynaud’s phenomenon - cardiac failure at time of Screening (Class III, according to NYHA Classification) or any severe cardiac disease as determined by the investigator - history of cardiac arrest - history of symptomatic bradycardia - resting pulse rate <55 bpm prior to randomization PLS SEE PROTOCOL
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the effect of FTY720 relative to placebo on delaying the time to sustained disability progression. Sustained disability progression is defined based on three types of events for each subject: 3-month sustained increase of at least 20% from Baseline in the timed 25-foot walk test (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-hole peg test (9-HPT)
    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 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) 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 EEA52
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-05-16. Yes
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 440
    F.4.2.2In the whole clinical trial 650
    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 Decision2008-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-02
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