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    Summary
    EudraCT Number:2011-001589-16
    Sponsor's Protocol Code Number:344-13-03-02-2010
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-05-02
    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 ConcernedFinland - Fimea
    A.2EudraCT number2011-001589-16
    A.3Full title of the trial
    MINOPTIC - A prospective, double-masked, placebo-controlled study on efficacy and safety of minicycline in the treatment of optic neuritis
    A.3.2Name or abbreviated title of the trial where available
    MINOPTIC
    A.4.1Sponsor's protocol code number344-13-03-02-2010
    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 SponsorHUCH Eye Hospital
    B.1.3.4CountryFinland
    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 supportFinnish Academy
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportKELA
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportMary and Georg c: Ehrnrooth Foundation
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportThe Evald and Hilda Nissi Foundation
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportThe Eye and Tissue Bank Foundation
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportEVO-funding
    B.4.2CountryFinland
    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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameMinocyclin-ratiopharm 100 mg
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboCapsule
    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
    optic neuritis
    E.1.1.1Medical condition in easily understood language
    optic neuritis
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    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 study is to evaluate the efficacy of minocycline in the treatment of optic neuritis as measured by visual acuity
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject has to fulfil the following criteria at the time of randomization:
    • The subject must give written informed consent prior to study activities
    • Age between 18 and 50 years
    • Has acute optic neuritis where the symptoms has lasted less than ten days and the visual acuity is less than 0.5 in either eye with best correction (standard criterion for conrticosteroid treatment). Subjects with optic neuritis as the first demyelinative event and subjects with previous diagnosis of MS with first optic neuritis are eligible
    • Pre-study MRI shows at least one white matter lesion of more than >3mm in diameter.
    E.4Principal exclusion criteria
    The subject must not be included if she/he fulfills any of the criteria at the time of randomization as mentioned below:
    • Any condition which might cause similar symptoms as MS
    • Has alcohol or drug abuse
    • Has contraindications to MRI
    • Has received treatment with steroids or ACTH later than 30 days before inclusion
    • Has had a relapse within 30 days prior to inclusion into this study
    • The patient has participated in any other clinical studies within 30 days prior to participating in the study
    • Patient is pregnant or breast-feeding or planning pregnancy
    - women in fertile age should have adequate contraception or be otherwise unlikely to become pregnant
    • Has been treated with interferons, azathioprine, mitoxantrone or glatiramer acetate six months before entering the study
    • Has elevated liver enzymes or has a known liver disease
    - SGOT/SGPT over two times the upper normal limit
    • Has known allergy to minocycline or other tetracyclines
    • Previous optic neuritis
    • Marked obesity (BMI>30) (risk of intracranial hypertension with tetracycline use)
    E.5 End points
    E.5.1Primary end point(s)
    • The primary endpoint is the visual acuity measured by using ETDRS chart at 6 months.
    o Mean change in ETDRS points
    o Number of patients with >15 points decrease in ETDRS points
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Pre-Study / Baseline visit, 1 month visit and 6 month visit
    E.5.2Secondary end point(s)
    • The number of new or enlarging lesions in T2 weighted MRI compared to baseline MRI.
    • The white matter lesion load (WMLL) in MRI compared to baseline.
    • The use of high-dose glucocorticoid treatment for relapses (0-24 months).
    • The number of patients without relapse at the end of study
    • Mean change in visual evoked potentials (VEP) P100 response at 6 months.

    Safety endpoints
    • The occurrence of serious adverse events during the active treatment period
    • The occurrence of adverse drug reactions during the active treatment period
    • Changes in laboratory parameters evaluated throughout the study

    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients have routinely MRI in pre-study and study related MRI at 6 month visit
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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 years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 150
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state150
    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)
    with normal treatment of that condition
    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 Decision2011-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-13
    P. End of Trial
    P.End of Trial StatusOngoing
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