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    Summary
    EudraCT Number:2013-002351-15
    Sponsor's Protocol Code Number:EMR200559006
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-02-28
    Trial 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 ConcernedAustria - BASG
    A.2EudraCT number2013-002351-15
    A.3Full title of the trial
    A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-β-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis
    Eine randomisierte, doppelblinde, multizentrische Doppel-Dummy-
    Studie der Phase III zum Vergleich der Wirksamkeit und Sicherheit von 2 Dosen von täglichem oralen ONO-4641 (0,05 mg und 0,1 mg) im Vergleich zu Interferon-Beta-1a 30 μg i.m. wöchentlich bei Patienten mit schubförmiger Multipler Sklerose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and safety of ONO-4641 versus Interferon-β-1a in patients with multiple sclerosis
    A.4.1Sponsor's protocol code numberEMR200559006
    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 SponsorMerck KGaA
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Centre merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code 64293
    B.5.3.4CountryGermany
    B.5.4Telephone number496151725200
    B.5.6E-mailservice@merckgroup.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.3.2Product code MSC2430913A or ONO-4641 (to be used as synonyms)
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNCeralifimod
    D.3.9.1CAS number 891859-12-4
    D.3.9.2Current sponsor codeMSC2430913A or ONO-4641 (to be used as synonyms)
    D.3.9.3Other descriptive nameONO-4641
    D.3.9.4EV Substance CodeSUB30962
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Avonex
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen IDEC LIMITED
    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.3.1Product nameAvonex
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAvonex
    D.3.9.1CAS number 220581-49-7
    D.3.9.3Other descriptive nameINTERFERON BETA-1A
    D.3.9.4EV Substance CodeSUB12440MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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.IMP: 3
    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.3.2Product code MSC2430913A or ONO-4641 (to be used as synonyms)
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNCeralifmod
    D.3.9.1CAS number 891859-12-4
    D.3.9.2Current sponsor codeMSC2430913A or ONO-4641 (to be used as synonyms)
    D.3.9.3Other descriptive nameONO-4641
    D.3.9.4EV Substance CodeSUB30962
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboIntramuscular use
    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 16.1
    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 trial is to demonstrate the effect of ONO 4641 versus interferon (IFN) β 1a (Avonex) 30 µg on the proportion of subjects, with relapsing-remitting multiple sclerosis (RRMS), who remain qualifying relapse–free during their participation in the trial when the last evaluable subject completes 1 year.
    E.2.2Secondary objectives of the trial
    "To demonstrate the effect of ONO 4641 versus:
    -IFN-β-1a (Avonex) 30 µg on qualifying ARR in subjects with RRMS treated over 2 years
    -IFN β 1a (30 µg) on the number of new or enlarging T2 lesions over 1 and 2 years
    -IFN β 1a (30 µg) on disability progression over 2 years and disability improvement over 2 years
    Other Secondary Objectives are to demonstrate the effect of ONO 4641 on:
    -additional clinical relapse outcomes (e.g., proportion relapse-free at 2 years) and MRI parameters (e.g., brain atrophy) in subjects with RRMS
    -disease-activity-free (DAF) status in subjects with RRMS
    -Symbol Digit Modalities Test (SDMT) and Paced Auditory Serial Addition Test (PASAT) as measures of cognitive function in subjects with RRMS
    To demonstrate the safety and tolerability of treatment with ONO 4641 in RRMS subjects"
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    "For inclusion in the trial, all of the following inclusion criteria must be fulfilled:
    A. Signed Informed Consent
    1. Written informed consent obtained prior to the initiation of any protocol-required procedures.
    B. Target Population
    2. Diagnosis of MS as defined by McDonald criteria of 2010
    3. Onset of MS symptoms within 12 years
    4. At least 1 documented relapse during the previous year OR at least 2 documented relapses during the previous 2 years prior to Randomization 5. EDSS (Expanded Disability Status Score) of 0 to 5.5, inclusive
    6. Clinically stable, with no relapse within 30 days prior to Randomization
    C. Age and Reproductive Status
    7. Male or female subjects 18 to 55 years of age
    8. Women of childbearing potential (WOCBP) must use 2 adequate forms of contraception to avoid pregnancy throughout the trial (such as a double barrier method) and for up to 8 weeks after the last dose of IMP in such a manner that the risk of pregnancy is minimized
    NOTE: WOCBP includes any female who has experienced menarche and who has not undergone successful sterilization (such as hysterectomy, bilateral tubal ligation, bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea > 12 consecutive months, or women on hormone replacement therapy with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL). Women using oral, implanted, or injectable contraceptive hormones or using mechanical products (such as an intrauterine device, diaphragm, condoms, etc) to prevent pregnancy; or practicing abstinence; or where the partner is sterile (such as with a vasectomy), must be considered to be of childbearing potential.
    9. WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) at the time of Screening AND a negative urine (dipstick) pregnancy test at the time of Randomization
    10. Women must not be breastfeeding
    11. Males must be surgically sterilized or agree to the use of a double-barrier method for the duration of the trial and must agree to refrain from sperm donation for the duration of the trial "
    E.4Principal exclusion criteria
    "A. Medical History and Concurrent Diseases
    1. Neuromyelitis optica, clinically isolated syndrome, primary or secondary progressive multiple sclerosis
    2. Chronic disease of the immune system other than MS or a known immunodeficiency syndrome
    3. Malignancy
    4. Macular edema or uveitis
    5. Corneal herpes
    6. Inability to undergo slit lamp and OCT assessments
    7. Inability to complete an MRI or contraindications for MRI
    8. History of sudden cardiac arrest
    9. Ischemic cardiac disease including myocardial infarction, stable angina pectoris, unstable angina pectoris
    10. Congestive heart failure New York Heart Association Class III or Class IV
    11. Uncontrolled hypertension
    12. Severe untreated sleep apnea
    13. Cerebrovascular disease in the 6 months prior to Randomization
    14. Symptomatic bradycardia or recurrent syncope
    15. Mobitz Type II second degree or high-grade AV block
    16. Sinoatrial heart block or sick sinus syndrome
    17. Resting HR of < 50 bpm on Screening ECG
    18. Higher risk of symptomatic bradycardia or heart block due to coexisting medical condition or certain concomitant medications
    19. Concurrent therapy with drugs that slow the HR or AV conduction
    20. Family history of long QT syndrome or sudden death
    21. Subjects receiving Class Ia or Class III anti-arrhythmic drugs
    22. Other arrhythmias such as ventricular tachycardia or atrial fibrillation requiring treatment
    23. Uncontrolled diabetes mellitus (Type I or Type II)
    24. Active or latent viral, fungal or other infections, including hepatitis B virus, hepatitis C virus, or known history of human immunodeficiency virus (HIV)-1 or HIV-2
    25. Active or chronic bacterial infection, including untreated tuberculosis, or history of untreated borreliosis (Lyme disease)
    26. Alcohol or drug abuse in the 12 months prior to Randomization
    27. Subject has been vaccinated with live, attenuated vaccines within 2 months prior to Randomization
    28. Renal condition that would preclude the administration of Gd
    29. Respiratory disease, such as pulmonary fibrosis, or asthma requiring chronic daily therapy (exception: resolved childhood asthma)
    30. Abnormal chest X-ray suggestive of active pulmonary disease
    31. Abnormal Pulmonary Function Tests: forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) < 75% or DLCO < 60%
    32. Any other unstable medical conditions (such as congenital heart disease, acute or chronic liver diseases, etc.)
    33. Current uncontrolled or untreated major depressive disorder, and/or at imminent risk of self harm or harm to others
    34. Known hypersensitivity to the trial treatment(s)
    B. Physical and Laboratory Test Findings
    35. Any other abnormal ECG finding, laboratory test result, or vital sign result
    36. Resting HR < 50 bpm based on ECG at Screening, or history of any cardiac conditions that might increase the risk of a significant reduction in HR
    37. Fridericia-corrected QT interval > 450 msec for male subjects and > 470 msec for female subjects on 12-lead ECG
    38. Left bundle branch block
    39. Right bundle branch block with fascicular block (left or right) or any ECG with RBBB and first degree AV block (PR interval > 240 msec) or RBBB with a QRS duration > 140 msec
    40. Intraventricular conduction defect with a QRS duration > 140 msec
    Laboratory exclusions:
    41. ALT or AST > 2 x ULN at Screening
    42. Serum creatinine > 1.5 mg/dL at Screening
    43. Total bilirubin > 1.5 x ULN (except for Gilbert’s disease) at Screening
    44. Lymphocyte count < 800 cells/µL at Screening
    45. WBC < 3,500 cells/µL at Screening
    46. Hemoglobin ≤ 9 g/dL at Screening
    47. Platelets < 100,000/mm3 at Screening
    48. Hemoglobin A1C > 7.5% at Screening
    C. Allergies
    49. History of allergic reaction to IFN-β-1a (Avonex).
    D. Prohibited Medications and Therapies
    50. Systemic corticosteroids or adrenocorticotropic hormone within 1 month prior to Randomization
    51. Immunoglobulins or plasmapheresis within 3 months prior to Randomization
    52. Cyclophosphamide, cladribine, or mitoxantrone at any time
    53. Immunosuppressive medications such as azathioprine, methotrexate, cyclophosphamide, cladribine, or mitoxantrone at any time
    54. Any previous therapy with alemtuzumab, ocrelizumab, ofatumumab, rituximab, belimumab, natalizumab, total body irradiation, or bone marrow transplantation
    55. Any investigational drug or placebo within 12 weeks prior to Randomization OR > 5 half lives prior to Randomization, whichever is longer
    56. Previous experimental procedures for the treatment of MS, such as treatment for chronic cerebrospinal venous insufficiency, or T-cell / T-cell receptor activation
    57. Any prior exposure to ONO 4641
    58. Prior therapy with fingolimod, or any treatment (either approved or investigational) for MS (excluding corticosteroids, plasmapheresis, immunoglobulins as described above) other than a β-interferon, glatiramer acetate, BG-12, or teriflunomide "


    E.5 End points
    E.5.1Primary end point(s)
    "Proportion of subjects free of qualifying relapse over at least 1 year (48 weeks).
    Relapses confirmed by the Adjudication Committee to meet the definition of qualifying relapse will contribute to the analysis for the primary endpoint."
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    E.5.2Secondary end point(s)
    "• The qualifying Annual Relapse Rate over 2 years
    • Number of new or enlarging hyperintense lesions on T2 weighted MRI over 1 and 2 years
    • Time to 3-month confirmed disability progression over 2 years
    • Time to 3-month confirmed disability improvement over 2 years
    • Time to 6-month confirmed disability progression and improvement over 2 years
    • Change from Baseline on the MSFC Z-score at 2 years
    • Proportion of subjects relapse-free over 2 years
    • Number and volume of new or persisting T1 Gd-enhancing lesions
    • T2 lesion volume
    • Number of combined unique active MRI lesions
    • Proportion of subjects with no new T1 Gd-enhancing lesions
    • Proportion of subjects with no new or enlarging T2 lesions
    • Number of new T1 hypointense lesions
    • Percent change in brain volume
    • Proportion of T1 Gd-enhancing lesions evolving into new persistent black holes
    • Proportion of subjects DAF (Disease Activity Free) (DAF status is defined as a subject having no qualifying relapse, no 3-month sustained change in EDSS, or no active lesions as assessed by MRI [new T1 Gd-enhancing lesions, or new/enlarging T2 lesions])
    • Change from Baseline in SDMT and PASAT scores
    • Safety and tolerability of ONO 4641
    "
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 2 years
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Double-dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA130
    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
    Argentina
    Austria
    Belarus
    Belgium
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Czech Republic
    Denmark
    Egypt
    Estonia
    Finland
    France
    Georgia
    Germany
    Hungary
    Italy
    Japan
    Jordan
    Latvia
    Lebanon
    Lithuania
    Mexico
    Morocco
    Peru
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    Spain
    Sweden
    Tunisia
    Turkey
    Ukraine
    United Arab Emirates
    United Kingdom
    United States
    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
    For administrative and safety reporting purposes, the end of the trial will be defined as the date of the final clinical database lock.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days23
    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: 1176
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 572
    F.4.2.2In the whole clinical trial 1176
    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)
    After completing 2 years of treatment, subjects will be offered the opportunity to continue active treatment in an Extension Trial.
    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 Decision2014-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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