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    The EU Clinical Trials Register currently displays   41228   clinical trials with a EudraCT protocol, of which   6756   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2015-000303-21
    Sponsor's Protocol Code Number:BIIT0115
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-04-01
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-000303-21
    A.3Full title of the trial
    A Phase IV, interventional, multicenteR, double-blind, randomized, placebo-controlled study tO explore the onset of efficacy on Magnetic resonance disease activity of BG00012 (dimethyl fumarate) in Patients with relapsing-remitTing Multiple Sclerosis (PROMPT)

    Studio di Fase IV interventistico, multicentrico, in doppio cieco, randomizzato, controllato verso placebo, per esplorare l’esordio di efficacia di BG00012 (dimetilfumarato), valutato tramite risonanza magnetica, in pazienti con sclerosi multipla recidivante-remittente (PROMPT)

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Experimental clinical trial regarding relapsing-remitTing Multiple Sclerosis newly diagnosed patients, not yet treated for the evaluation of the onset, the efficacy and speed of action of the treatment with BG00012
    Studio clinico di tipo sperimentale in pazienti affetti da sclerosi multipla recidivante-remittente di nuova diagnosi, non ancora trattati per valutare l'esordio, l'efficacia e la velocità di azione del trattamento con BG00012
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberBIIT0115
    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.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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGB Pharma Services & Consulting S.r.l. Unipersonale
    B.5.2Functional name of contact pointClinical Research department
    B.5.3 Address:
    B.5.3.1Street Addressvia Ferreri, 11
    B.5.3.2Town/ cityPavia
    B.5.3.3Post code27100
    B.5.4Telephone number+39 0382530676
    B.5.5Fax number+390382302619
    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. name Tecfidera®
    D. of the Marketing Authorisation holderBiogen Idec Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameTecfidera®
    D.3.2Product code BG00012
    D.3.4Pharmaceutical form Capsule
    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 INNDimethyl fumarate
    D.3.9.1CAS number 624-49-7
    D.3.9.2Current sponsor codeBG00012
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Relapsing-remitting Multiple Sclerosis patients
    Pazienti con sclerosi multipla recidivante-remittente
    E.1.1.1Medical condition in easily understood language
    relapsing-remitting Multiple Sclerosis patients
    Pazienti con sclerosi multipla recidivante-remittente
    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 17.1
    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 early efficacy of treatment with BG00012 240 mg BID in the brain of newly diagnosed and naive-to-treatment patients with RRMS.
    L’obiettivo primario dello studio è valutare l'esordio e la velocità di efficacia del trattamento con BG00012 240 mg BID, valutata con RMN, in pazienti affetti da SMRR di nuova diagnosi e naive al trattamento.
    E.2.2Secondary objectives of the trial
    It will be evaluated the time course of the treatment and safety of BG00012.
    Sarà valutato l'andamento nel tempo dell' effetto benefico del trattamento e la sicurezza di BG00012.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected information in accordance with local subject privacy regulations.
    •Patients with RRMS (McDonald criteria, 2010) who do not accept current injectable first-line DMTs
    •Age between 18 and 50 years at the time of informed consent.
    •MS onset within one year before enrollment (V0)
    •≥ 1 Gd+ lesions at a brain MRI scan performed within three months before enrollment(V0).
    •No previous disease modifying and/or immunosuppressive treatments for MS
    •Must have a baseline EDSS between 0.0 and 5.0, inclusive.
    •Women of childbearing potential (i.e. who are not post-menopausal for at least 1 year) and men 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.
    •Capacità di capire lo scopo e i rischi dello studio e di fornire un consenso datato e firmato e l’autorizzazione al trattamento dei dati sensibili secondo la normativa
    •Pazienti con sclerosi multipla recidivante-remittente (RRMS) (secondo i criteri di McDonald, 2010), che non accettano leterapie"disease modifying" di prima linea iniettabili attualmente disponibili
    •Età tra i 18 e i 50 anni al momento del consenso informato
    •Esordio della malattia nell’anno precedente l' arruolamento (V0)
    •≥ 1 lesione Gd+ alla RMN cerebrale eseguita entro tre mesi prima dell' arruolamento (V0)
    •Nessun precedente trattamento per la SM (nè di tipo immunosoppressivo nè "disease modifying")
    •EDSS basale tra 0.0 e 5.0 (compreso)
    •Le donne in età riproduttiva (cioè che non siano in menopausa almeno da 1 anno) e gli uomini dovranno utilizzare un metodo contraccettivo sicuro (a giudizio dello sperimentatore) nel corso dello studio e per almeno 30 giorni dopo l’ultima dose del trattamento in studio.
    E.4Principal exclusion criteria
    •Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
    •Previous disease modifying and/or immunosuppressive treatments for MS, including T-cell or T-cell receptor vaccination, any therapeutic monoclonal antibody, Mitoxantrone, Cyclophosphamide
    •Previous treatment with Fumaderm®, dimethyl fumarate or other fumarates
    •History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
    •History of severe allergic or anaphylactic reactions or known drug hypersensitivity. Known allergy / hypersensitivity to Gadolinium.
    •History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that in the opinion of the Investigator would preclude participation in a clinical trial.
    •Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements.
    •History of or positive test result at screening for human immunodeficiency virus (HIV). Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
    •History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to inclusion.
    •An MS relapse that has occurred within the 30 days prior to inclusion (screening) AND/OR the subject has not stabilized from a previous relapse prior to inclusion.
    •Malattia primaria progressiva, secondaria progressiva o recidivante progressiva, come definito da Lublin and Reingold (Lublin and Reingold 1996)
    •Precedente trattamento con Fumaderm®, dimetil-fumarato e/o altri fumarati
    •Precedente trattamento Disease-Modifying e/o immunosoppressivo per la sclerosi multipla, inclusi il vaccino contro i linfociti T o i loro recettori, qualunque anticorpo monoclonale terapeutico, mitoxantrone, ciclofosfamide.
    •Anamnesi di neoplasie (eccetto il basalioma cutaneo completamente asportato e il carcinoma in situ cervicale sottoposto a conizzazione)
    •Anamnesi di gravi reazioni allergiche o anafilattiche o nota ipersensibilità a farmaci o al Gadolinio
    •Anamnesi di anomalie nei test di laboratorio che indichino qualunque significativa malattia endocrinologica, ematologica, epatica, immunologica, metabolica, uro-nefrologica, e/o altre malattie maggiori che nell’opinione dello sperimentatore possano precludere la partecipazione ad uno studio clinico.
    •Anamnesi di malattie intercorrenti non controllate, incluse, ma non limitate a: infezioni attive o in corso, insufficienza cardiaca congestizia sintomatica, angina pectoris instabile, aritmia cardiaca, disfunzioni serie o acute a livello epatico, renale o midollare, diabete non controllato, malattie psichiatriche serie o in fase acuta, che comportino la non conformità ai requisiti richiesti dallo studio.
    •Positività al test per l’HIV o per l’epatite B o C allo screening.
    •Anamnesi di abuso di sostanze o alcol nei 2 anni precedenti l’inclusione.
    •Recidiva di SM che sia insorta nei 30 giorni precedenti lo screening, E/O mancata stabilizzazione del paziente da una precedente recidiva prima dell’inclusione.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the mean number of cumulative combined unique active (CUA) lesions from week 4 to 24
    End point primario: Numero medio di lesioni attive uniche combinate (CUA) cumulative dalla settimana 4 alla settimana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From the fourth to the twenty-fourth week
    dalla settimana 4 alla settimana 24.
    E.5.2Secondary end point(s)
    •Mean number of CUA at 4, 8, 12, 16, 20 and 24 weeks
    •New/enlarging T2 lesions at 4, 8, 12, 16, 20 and 24 weeks
    •New Gd+ lesions at 4, 8, 12, 16, 20 and 24 weeks
    •Mean number of hypointense T1 lesions at 24 weeks
    •Safety of BG00012 treatment
    - Numero medio di CUA alle settimane 4, 8, 12, 16, 20 e 24.
    - LesioniT2nuove/ingrandite alle settimane 4, 8, 12, 16, 20 e 24
    - Nuove lesioni captanti gadolinio (Gd+) alle settimane 4, 8, 12, 16, 20 e 24
    - Numero medio di lesioni ipointense T1 alla settimana 24
    -Sicurezza del trattamento con BG00012
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Mean number of CUA at 4, 8, 12, 16, 20 and 24 weeks
    •New/enlarging T2 lesions at 4, 8, 12, 16, 20 and 24 weeks
    •New Gd+ lesions at 4, 8, 12, 16, 20 and 24 weeks
    •Mean number of hypointense T1 lesions at 24 weeks
    •Safety of BG00012: from IC signature to the end of the study (week 28)
    - Numero medio di CUA alle settimane 4, 8, 12, 16, 20 e 24.
    - LesioniT2nuove/ingrandite alle settimane 4, 8, 12, 16, 20 e 24
    - Nuove lesioni captanti gadolinio (Gd+) alle settimane 4, 8, 12, 16, 20 e 24
    - Numero medio di lesioni ipointense T1 alla settimana 24
    -Sicurezza di BG00012: dalla firma del consenso alla fine dello studio (settimana 28)
    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 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. 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 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 concerned20
    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
    ultima visita per ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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: 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 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 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)
    For patients accessing to the rescue program, alternative drugs will not be supplied by the Sponsor in this study. Treating neurologist may choose among currently available disease modifying treatments (DMTs) according to clinical practice and EMA indication.
    Per i pazienti che accedono al rescue program, non verranno forniti dallo sponsor farmaci alternativi. Il Neurologo può scegliere tra i trattamenti modificanti la malattia (DMT) disponibili in queso momento in accordo col la normale pratica clinica e le indicazioni dell'EMA.
    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 Decision2015-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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