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    Summary
    EudraCT Number:2013-001196-20
    Sponsor's Protocol Code Number:H2013
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-08-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-001196-20
    A.3Full title of the trial
    PROSPECTIVE STUDY ON THE EFFECTIVENESS OF TWO DIFFERENT DOSES OF INTRAVENOUS METHYLPREDNISOLONE IN THE TREATMENT OF ACUTE DYSTHYROID OPTIC NEUROPATHY
    STUDIO PROSPETTICO SULL'EFFICACIA DI DUE DIFFERENTI DOSI DI METILPREDNISOLONE NEL TRATTAMENTO DELL'OTTICOPATIA DISTIROIDEA ACUTA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFICACY OF STEROIDS IN THE TREATMENT OF DYSTHYROID OPTIC NEUROPATHY
    EFFICACIA DEGLI STEROIDI NEL TRATTAMENTO DELL'OTTICOPATIA DISTIROIDEA ACUTA
    A.4.1Sponsor's protocol code numberH2013
    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 SponsorFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO MILANO
    B.1.3.4CountryItaly
    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 supportFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO MILANO
    B.5.2Functional name of contact pointNICOLA CURRO'
    B.5.3 Address:
    B.5.3.1Street AddressVIA F.SFORZA N. 35
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number+3925503.3912
    B.5.5Fax number+39250320423
    B.5.6E-mailnicolacurro@virgilio.it
    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 SOLUMEDROL
    D.2.1.1.2Name of the Marketing Authorisation holderPHARMACIA UPJOHN S.p.A
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameSOLUMEDROL
    D.3.2Product code 83-43-2
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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 Yes
    D.3.11.13.1Other medicinal product typeCHEMICAL
    D.IMP: 2
    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 SOLUMEDROL
    D.2.1.1.2Name of the Marketing Authorisation holderPHARMACIA UPJOHN S.p.A
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameSOLUMEDROL
    D.3.2Product code 83-43-2
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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 Yes
    D.3.11.13.1Other medicinal product typeCHEMICAL
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    GRAVES' ORBITOPATHY
    ORBITOPATIA DI GRAVES
    E.1.1.1Medical condition in easily understood language
    GRAVES' ORBITOPATHY
    ORBITOPATIA DI GRAVES
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10057889
    E.1.2Term Graves' ophthalmopathy
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test the efficacy and safety of two different dosages of pulsed iv methylprednisolone for the treatment of dysthyroid optic neuropathy (DON):

    regimen 1) 1g of MP administered daily for 3 consecutive days, for 2 consecutive weeks, tapered off with 8 infusion of 250 mg of MP (cumulative dose= 8g)
    regimen 2) 500 mg of MP administered daily for 3 consecutive days, for 2 consecutive weeks, tapered off with 8 infusion of 250 mg of MP (cumulative dose= 5g)
    - confrontare efficacia e sicurezza di due dosaggi di Metilprednisolone, somministrato per via endovenosa (IVMP), impiegati per il trattamento dell'otticopatia distiroidea acuta (DON):
    schema 1) 1g di MP ripetuto per 3 giorni consecutivi di 2 settimane consecutive seguito da 8 infusioni da 250 mg (dose cumulativa = 8g)
    schema 2) 500 mg di MP ripetuto per 3 giorni consecutivi di 2 settimane consecutive seguito da 8 infusioni da 250 mg (dose cumulativa = 5g)
    E.2.2Secondary objectives of the trial
    1. Safety and tolerability of the two therapeutic protocols.
    2. Factors influencing clinical response
    3. Improvement in quality of life
    4. Inactivation of GO (CAS ≤ 2)
    5. Need for additional surgical treatment.
    1. valutare la sicurezza dei due schemi terapeutici utilizzati
    2. individuare eventuali variabili che possano essere utilizzate come fattori predittivi di risposta alla terapia
    3. valutare il miglioramento della qualità di vita del paziente
    4. capacità dello steroide di inattivare la fase infiammatoria della malattia (CAS ≤ 2)
    5. necessità di procedure chirurgiche entro l’anno dal trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with recent onset of signs of DON with at least two of the following:

    - definite disc swelling
    - definite RAPD
    - loss of colour vision (>2/6 errors at HRR plates)
    - reduced BCVA (less than Logmar 0.0 or pre disease BCVA)
    Pazienti con recente insorgenza di segni di DON con almeno due dei seguenti riscontri:
    - edema di papilla
    - RAPD
    - Discromatopsia (> 2/6 errori alle tavole HRR
    - Riduzione della BCVA (rispetto a Logmar 0.0 o alla BCVA registrata prima dell’insorgenza della DON.
    E.4Principal exclusion criteria
    - Age under 18 yrs
    - Active viral hepatitis,
    - elevated liver enzymes (4 times upper normal limits)
    - other active chronic infection
    - Severe heart disease (unstable angina, or recent (within previous 6 months) acute coronary syndrome, or heart failure worse than class 2 NYHA);
    - severe systemic hypertension (hypertension requiring more than 4 antihypertensive drugs to maintain control); uncontrolled hypertension=>180/110;
    - Uncontrolled diabetes (HbA1c > 8% )
    - Active peptic ulcer
    - Pregnancy
    - Lack of effective contraception in fertile women
    - lack of mental capacity, significant psychiatric illness / inability to obtain informed consent
    - Presence of other neurological or ophthalmological (cataract, glaucoma, AMD, etc) diseases that could significantly affect visual function
    - Previous orbital surgery in the affected eye/eyes.
    - Previous unresponsiveness to IVMP for DON.
    - More than 2g of MP in the previous 12 months
    - Minore età
    - Inabilità, incapacità di esprimere consenso informato.
    - Presenza di coesistenti malattie oculari o neurologice potenzialmente in grado di influire sulla funzione visiva
    - Precedente chirurgia dell'orbita/e affetta/e da DON
    - Precedente non responsività a trattamento steroideo per DON
    - Assunzione di più di 2g di metilprednisolone negli ultimi 12 mesi
    - Epatite virale attiva
    - Enzimi epatici elevate (4 volte sopra I limiti di normalità)
    - Altre infezioni croniche attive
    - Malattie cardiache gravi (angina instabile o recente (6 mesi) infarto cardiaco o scompenso cardiaco peggiore della classe 2 NYHA.
    - Grave ipertensione sistemica (più di 4 farmaci per mantenere il controllo pressorio o PA > 180/110 mmHg
    - Diabete scompensato (HbA1c > 8%)
    - Ulcera gastrica attiva
    - Gravidanza
    - Gravidanza potenzialmente possible in assenza di adeguate misure contraccettive
    E.5 End points
    E.5.1Primary end point(s)
    Adequate recovery of visual function (when at least 3 of the following are present), assessed at one and 3 months :
    - BCVA ≥ 0.7 (logmar 0,18) or two lines within pre DON values
    - ≤than three errors on HRR
    - Disc swelling recovered
    - Visual field MD improved of at least 3dB compared to baseline or MD > - 6 Db
    The primary endpoint will be assessed at 1 and 3 months
    Ripristino di una adeguata funzione visiva (definita dalla presenza di almeno 3 dei seguenti riscontri):
    - BCVA ≥ 0.7 (logmar 0,18) o raggiungimento di valori entro 2 linee rispetto alla BCVA pre DON
    - ≤ 3 errori all HRR
    - risoluzione dell'edema di papilla
    - MD del campo visivo migliorato di almeno 3 dB or MD > - 6 dB
    L'endpoint primario verrà testato a 1 e 3 mesi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be assessed at 1 and 3 months
    L'endpoint primario verrà testato a 1 e 3 mesi
    E.5.2Secondary end point(s)
    Adequate recovery of visual function (when at least 3 of the following are present), assessed at one and 3 months :
    - BCVA ≥ 0.7 (logmar 0,18) or two lines within pre DON values
    - ≤than three errors on HRR
    - Disc swelling recovered
    - Visual field MD improved of at least 3dB compared to baseline or MD > - 6 Db
    The secondary end point will be assessed at 6 months
    Ripristino di una adeguata funzione visiva (definita dalla presenza di almeno 3 dei seguenti riscontri):
    - BCVA ≥ 0.7 (logmar 0,18) o raggiungimento di valori entro 2 linee rispetto alla BCVA pre DON
    - ≤ 3 errori all HRR
    - risoluzione dell'edema di papilla
    - MD del campo visivo migliorato di almeno 3 dB or MD > - 6 dB
    L'endpoint secondario verrà testato a 6 mesi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Belgium
    France
    Germany
    Switzerland
    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
    LPLV
    LPLV
    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: 70
    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 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 state35
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 70
    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 Decision2013-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-14
    P. End of Trial
    P.End of Trial StatusOngoing
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