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    Summary
    EudraCT Number:2013-002515-10
    Sponsor's Protocol Code Number:P000053
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-16
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-002515-10
    A.3Full title of the trial
    Treatment of Optic Neuritis with Erythropoietin: a randomised, double-blind, placebo-controlled trial
    Behandlung der Optikusneuritis mit Erythropoietin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of an inflammation of the optic nerve with a medical drug (Erythropoietin)
    Behandlung des entzündlichen Befalls des Sehnervs mit einem Arzneimittel (Erythropoietin)
    A.3.2Name or abbreviated title of the trial where available
    TONE
    TONE
    A.4.1Sponsor's protocol code numberP000053
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01962571
    A.5.4Other Identifiers
    Name:DRKSNumber:DRKS00005298
    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 SponsorUniversity Medical Center Freiburg
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFederal Ministry Of Education And Research
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Freiburg
    B.5.2Functional name of contact pointClinical Trials Unit
    B.5.3 Address:
    B.5.3.1Street AddressElsaesser Str. 2
    B.5.3.2Town/ cityFreiburg
    B.5.3.3Post code79110
    B.5.3.4CountryGermany
    B.5.4Telephone number+4976127074000
    B.5.5Fax number+4976127073730
    B.5.6E-mailbirgit.grotejohann@uniklinik-freiburg.de
    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 Epoetin alfa HEXAL® 40.000 I.E./1 ml Injektionslösung in einer Fertigspritze
    D.2.1.1.2Name of the Marketing Authorisation holderHexal AG, Industriestraße 25, D-83607 Holzkirchen
    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 Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEPOETIN ALFA
    D.3.9.1CAS number 113427-24-0
    D.3.9.3Other descriptive nameEPO
    D.3.9.4EV Substance CodeSUB06575MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40.000
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Optic Neuritis
    Optikusneuritis
    E.1.1.1Medical condition in easily understood language
    Acute inflammation of the optical nerve
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10030942
    E.1.2Term Optic neuritis
    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
    Determination of the efficacy of erythropoietin compared to placebo given as add-on to methylprednisolone (standard of care) as assessed by measurements of global retinal nerve fibre layer thickness (RNFLT-G) and low contrast visual acuity (LCVA) 6 months after randomisation
    E.2.2Secondary objectives of the trial
    Comparison of efficacy of erythropoietin compared to placebo given as add-on to methylprednisolone with respect to RNFLT and other functional changes 6 months after randomisation
    and
    assessment of safety in both treatment arms
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained according to international guidelines and local laws
    2. Male and female patients aged ≥ 18 to ≤ 50 years
    3. Patients with optic neuritis
    4. First symptoms of optic neuritis ≤ 10 days prior to the first administration of investigational product
    5. High contrast visual acuity (HCVA) of ≤ 0.5 (decimal system)
    6. Adequate Optical Coherence Tomography (OCT) measurements available
    E.4Principal exclusion criteria
    1. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
    2. Simultaneous participation in another interventional trial which could interfere with this trial and/or participation in a clinical trial within the last 3 months before enrolment in this trial
    3. Refractive anomalies: Hyperopia > 5 dpt, myopia < -7 dpt, astigmatism > 3 dpt
    4. Media opacity
    5. Severe papillitis
    6. Previous ON
    7. Any other optic nerve and retinal disease
    8. Pre-existing MS or any other neurological disease
    9. Congenital diseases:
    • thrombophilia
    • phenylketonuria
    10. Acquired diseases:
    • autoimmune diseases,
    • cardiovascular diseases,
    • diabetes mellitus,
    • uncontrolled hypertension (with blood pressure > 140 / 90 mm Hg),
    • any malignancy,
    • epilepsy,
    • known tuberculosis with ongoing or unknown activity,
    • acute gastrointestinal ulceration within the last 3 months prior to randomisation,
    • acute viral, bacterial or fungal infection,
    • known infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus, or Hepatitis C Virus,
    • history of colitis ulcerosa, diverticulitis, or acute enteroanastomosis,
    • known osteoporosis,
    • history of thromboembolic events,
    • elevated haemoglobin level (>17 g/dl in men or >15 g/dl in women),
    • polycythaemia
    • any other significant illness potentially interfering with any trial assessment or treatment
    11. Performing semi-professional or professional sporting activities or physical training
    12. Pre-treatment with corticosteroids in the last 30 days prior to the onset of optic neuritis
    13. Pre-treatment with EPO
    14. Known or persistent abuse of medication, drugs or alcohol
    15. Active immunization within 2 weeks prior to randomisation
    16. Significant surgery within 4 weeks prior to randomisation
    17. Blood donation or bloodletting within 4 weeks prior to screening
    18. Pre-treatment with immunosuppressive or immunomodulatory agents
    19. Persons who are in a relationship of dependence/employment with the sponsor or the investigator

    Additional specific exclusion criteria for female patients who are able to have a child
    20. Current or planned pregnancy, nursing period within 3 months from investigational product administration
    21. Unwillingness to use one of the following safe combination methods of contraception within 3 months from investigational product administration to achieve a PEARL index of <1: female condom, diaphragm or coil, each used in combination with a spermicide; hormonal intra-uterine device or hormonal contraception in combination with a mechanical method of contraception
    E.5 End points
    E.5.1Primary end point(s)
    1) RNFLT-G-12 of contralateral healthy eye at baseline minus RNFLT-G-12 of the affected eye 6 months after randomisation
    2) low contrast visual acuity (LCVA) in the affected eye 6 months after randomisation
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after randomisation
    E.5.2Secondary end point(s)
    - 7 OCT analyses will be performed to increase the likelihood of capturing axonal changes:
    1. RNFLT in the papillomacular bundle (RNFLT-PMB-12) fellow eye at baseline minus RNFLT-PMB-12 affected eye 6 months after randomisation
    2. RNFLT in the temporal quadrant (RNFLT-T-12) fellow eye at baseline minus RNFLT-T-12 affected eye 6 months after randomisation
    3. RNFLT-G-12 of the affected eye 6 months after randomisation
    4. RNFLT-PMB-12 of the affected eye 6 months after randomisation
    5. RNFLT-T-12 of the affected eye 6 months after randomisation
    6. Total macular volume (TMV) in the fellow eye at baseline minus TMV of the affected eye 6 months after randomisation
    7. TMV of the affected eye 6 months after randomisation


    - further analyses of manually segmented retinal layers (e.g. thickness of retinal ganglion cell layer plus inner plexiform layer)

    - Assessment of safety in both treatment arms as additional secondary objective evaluated in terms of
    - adverse events,
    - serious adverse events,
    - and laboratory data (haemoglobin, EPO antibodies)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 6 months after randomisation
    - AEs: during the course of the trial
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life (National Eye Institute Visual Functioning Questionnaire)
    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.8.2.4Number 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 concerned12
    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
    LVLS
    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 days0
    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: 108
    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 state108
    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)
    None
    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 Decision2014-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-26
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