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    Summary
    EudraCT Number:2013-001422-25
    Sponsor's Protocol Code Number:ITA-BGT-12-10389
    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:2013-04-17
    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 number2013-001422-25
    A.3Full title of the trial
    Single country study assessing cognition in Relapsing Remitting Multiple Sclerosis patients treated with BG00012
    Studio “single-country” per la valutazione delle funzioni cognitive in pazienti affetti da Sclerosi Multipla Recidivante Remittente trattati con BG00012
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to be conducted only in Italy to evaluate the effect of the treatment with BG00012 on cognitive function in patients with Relapsing Remitting Multiple Sclerosis
    Studio condotto solo in Italia per valutare l’effetto dell trattamento con BG00012 sulle funzioni cognitive in soggetti affetti da Sclerosi Multipla Recidivante Remittente
    A.4.1Sponsor's protocol code numberITA-BGT-12-10389
    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 SponsorBiogen Idec Italia S.r.l.
    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 supportBiogen Idec Italia S.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Italia
    B.5.2Functional name of contact pointMedical Affairs
    B.5.3 Address:
    B.5.3.1Street AddressCentro Leoni Via Spadolini, 5
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20141
    B.5.3.4CountryItaly
    B.5.4Telephone number+390258499047
    B.5.5Fax number+390258499133
    B.5.6E-mailguido.sabatella@biogenidec.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.3.1Product namedimethyl fumarate [DMF]
    D.3.2Product code BG00012
    D.3.4Pharmaceutical form Capsule, hard
    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 INNdimetilfumarato
    D.3.9.1CAS number 624-49-7
    D.3.9.2Current sponsor codeBG00012
    D.3.9.3Other descriptive nameDIMETHYL FUMARATE
    D.3.9.4EV Substance CodeSUB13608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    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 (RRMS)
    Sclerosi Multipla Recidivante Remittente (SMRR)
    E.1.1.1Medical condition in easily understood language
    Autoimmune disease of the central nervous system characterized by alternating relapses.
    Malattia autoimmune del Sistema Nervoso centrale caratterizzata da alternanza di ricadute
    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 14.1
    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 the study is to assess the BG00012 treatment effect on cognition over 2 year period in RRMS patients
    L’obiettivo primario dello studio consiste nel valutare l’effetto del trattamento con BG00012 sulle funzioni cognitive nei pazienti affetti da SMRR in un periodo di 2 anni
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to further assess BG-12 treatment effect on cognition, predictors of cognitive impairment, clinical efficacy, and patient reported outcomes. In additional the relationship between cognition and patient reported outcome on depression, fatigue, quality of life, and work and social life activity will be examined.
    Additional Assessment:
    - any adverse event (including relapses) that could occur throughout the study
    - comparison of Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) versus Rao’s Brief Repeatable Battery of Neuropsychological Tests (BRB) together with Stroop Test as a screening tool of cognitive impairment in patients with RRMS.
    L’obiettivo secondario dello studio è di valutare ulteriormente l’effetto del trattamento con BG00012 sulle funzioni cognitive, sui fattori predittivi del deficit cognitivo, sull’efficacia clinica e sui “patient reported outcomes”. Sarà inoltre esaminata la relazione tra funzioni cognitive e “patient reported oucomes” su depressione, “fatigue, qualità della vita e attività lavorativa e sociale.
    Ulteriori valutazioni:
    - qualsiasi evento avverso (incluse le recidive) che si verifichi durante lo studio
    - confronto della performance della batteria di Rao e Stroop Test e della batteria BICAMS nella valutazione delle funzioni cognitive
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with local subject privacy regulations.
    2. Age ≥18 years at the time of informed consent.
    3. Must have a confirmed diagnosis of RRMS according to McDonald criteria (Polman, Reingold et al. 2005).
    4. Must have a baseline EDSS between 0.0 and 5.0, inclusive.
    5. Must have experienced at least 1 relapse within the 12 months prior to randomization, with a prior brain MRI demonstrating lesion(s) consistent with MS, or show evidence of Gd-enhancing lesion(s) of the brain on an MRI performed within the 6 weeks prior to randomization.
    6. Subjects of childbearing potential (including female subjects who are not post-menopausal for at least 1 year) must practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. For further details of contraceptive requirements for this study, please refer to Section 15.5.3.
    1. Capacità di comprendere lo scopo e rischi dello studio e fornire firmato e datato il consenso informato firmato e datato e l'autorizzazione ad utilizzare le informazioni sanitarie personali, in conformità con la normativa sulla privacy locale.
    2. età ≥ 18 anni al momento del consenso informato
    3. Deve avere una diagnosi confermata di SMRR in base a criteri di McDonald (Polman, Reingold et al. 2005)
    4. Deve avere un EDSS al basale compreso tra 0.0 e 5.0, incluso
    5. Deve aver sperimentato almeno 1 recidiva nei 12 mesi precedenti la randomizzazione, con una lesione al cervello rilevata da MRI compatibile con MS, o che mostri segni di lesione del cervello captante il gadolinio da MRI effettuata entro 6 settimane prima della randomizzazione.
    6. Soggetti in età fertile (inclusi soggetti di sesso femminile che non sono in post-menopausa da almeno 1 anno) devono adottare un sistema di contraccezione efficace (come definito dallo sperimentatore) durante lo studio ed essere disposti e in grado di continuare la contraccezione per 30 giorni dopo la loro ultima dose di trattamento di studio. Per ulteriori dettagli su requisiti di contraccettivi per questo studio, si prega di fare riferimento alla Sezione 15.5.3 del protocollo.
    E.4Principal exclusion criteria
    1. Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
    2. Severe depression (MADRS score >34) (Montgomery and Asberg 1979)
    3. History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
    4. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
    For a complete list see te protocol
    1. Sclerosi multipla progressiva primaria, secondaria progressiva o progressiva recidivante come definito da Lublin and Reingold (Lublin and Reingold 1996)
    2. Depressione grave (MADRS score >34) (Montgomery and Asberg 1979)
    3. Storia di neoplasia maligna (eccetto il carcinoma a cellule basali, che è stato completamente asportato prima dell'arruolamento nello studio)
    4. Storia di gravi reazioni allergiche o anafilattiche o ipersensibilità conosciuta ai farmaci.
    Per un elenco completo dei criteri di esclusione si faccia riferimento al protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with worsening in CI.
    Proporzione di pazienti con un peggioramento del peggioramento cognitivo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    over 2 years
    a 2 anni
    E.5.2Secondary end point(s)
    •Change in cognitive impairment index score (CII) over two years
    •Annualized relapse rate (ARR) at year 1 and year 2. Proportion of relapse at year 1 and year 2, and time to relapse over 2 years.
    •Proportion of patients with 6-month sustained progression of disability
    • Assessment of baseline demographic, disease characteristics and related patient reported outcomes that predict CI at two years.
    •Change from baseline over two years in patient reported outcomes:
    - Depression
    - Fatigue- Quality of life- Work/social life activity
    • Variazioni del Cognitive Impairment Index score (CII) a 2 anni.
    • Tasso annualizzato di ricadute (Annualized relapse rate, ARR) a 1 e 2 anni. Proporzione di pazienti con ricadute a 1 e 2 anni e tempo alla recidiva a 2 anni.
    • Proporzione di pazienti con progressione di disabilità mantenuta a 6 mesi
    • Valutazione al basale dei dati demografici, delle caratteristiche della malattia e dei “patient reported outocomes” predittivi di un CI a 2 anni.
    • Variazione dal basale a 2 anni nei seguenti “patient reported outcomes”:
    - Depressione
    - “Fatigue”
    - Qualità della vita
    - Attività lavorativa/vita sociale
    E.5.2.1Timepoint(s) of evaluation of this end point
    see above
    vedere sopra
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 trial1
    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 concerned24
    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
    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
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state220
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 220
    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)
    at the end of the study there are no follow-up visits or further supply of the drug.
    al termine dello studio non sono previste visite di follow-up né ulteriore fornitura del farmaco.
    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 Decision2013-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
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