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    Summary
    EudraCT Number:2012-005082-13
    Sponsor's Protocol Code Number:101MS328
    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:2013-02-18
    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 number2012-005082-13
    A.3Full title of the trial
    A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects with Relapsing Remitting Multiple Sclerosis
    Studio di fase I, multicentrico, in aperto, a braccio singolo, a dose multipla per valutare la farmacocinetica e la farmacodinamica di natalizumab in soggetti pediatrici con sclerosi multipla recidivante remittente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects with Relapsing Remitting Multiple Sclerosis
    Studio di fase I, multicentrico, in aperto, a braccio singolo, a dose multipla per valutare la farmacocinetica e la farmacodinamica di natalizumab in soggetti pediatrici con sclerosi multipla recidivante remittente
    A.4.1Sponsor's protocol code number101MS328
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/252/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBiogen Idec Research Limited
    B.1.3.4CountryUnited Kingdom
    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 Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointnot available
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead Berkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441628501000
    B.5.5Fax number441628501010
    B.5.6E-mailcta.submissions@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 Yes
    D.2.1.1.1Trade name TYSABRI
    D.2.1.1.2Name of the Marketing Authorisation holderElan Pharma International Ltd
    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.3.2Product code AN100226, BG00002
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNNATALIZUMAB
    D.3.9.1CAS number 189261-10-7
    D.3.9.4EV Substance CodeSUB22282
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    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
    Sclerosi Multipla Recidivante Remittente
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Sclerosi Multipla
    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 determine the PK profile of multiple doses of natalizumab in pediatric subjects with RRMS.
    L’obiettivo primario dello studio è di determinare il profilo PK di dosi multiple di natalizumab nei soggetti pediatrici affetti da SMRR
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study in this study population are as follows:
    • To characterize the PD profile of natalizumab (as defined by α4 integrin binding).
    • To determine the safety and tolerability of multiple doses of natalizumab.
    Gli obiettivi secondari di questo studio in questa popolazione dello studio sono i seguenti: • Caratterizzare il profilo PD di natalizumab (definito dal legame con integrina α4). • Determinare la sicurezza e la tollerabilità di dosi multiple di natalizumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of enrollment or at the timepoint specified in the individual eligibility criterion listed:
    1. Ability of parents or legal guardians 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 national and local subject privacy regulations. Subjects may provide assent in addition to the parental or guardian consent, if appropriate.
    2. Aged from 10 to less than 18 years old at the time of informed consent or assent.
    3. Diagnosis of RRMS according to Krupp [Krupp 2007] on behalf of the International Pediatric MS Study Group and Polman [Polman 2011] at Screening. RRMS diagnosis must be confirmed by a brain MRI scan performed within the 12 months prior to Screening or at Screening.
    4. It has been determined by the treating physician that natalizumab treatment is appropriate for this subject based on their disease status.
    5. Subjects of childbearing potential, who are sexually active, must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last infusion of study treatment. For further details of contraceptive requirements for this study, please refer to Section 15.5.3.
    Per essere idonei a partecipare a questo studio, i candidati devono soddisfare i seguenti criteri di idoneità al momento dell'arruolamento o al momento specificato nel criterio di inclusione individuale elencato: 1. Capacità dei genitori o tutori legali di capire lo scopo e rischi dello studio e fornire il consenso informato firmato e datato e l'autorizzazione ad utilizzare le informazioni sanitarie protette, in conformità con le normative nazionali e locali in materia di privacy. I soggetti possono fornire un assenso in aggiunta al consenso dei genitori o del tutore, se appropriato. 2. Devono avre un’età da maggiore o uguale di 10 anni a meno di 18 anni al momento del consenso informato o dell’assenso. 3. Diagnosi di SMRR secondo Krupp [Krupp 2007] a nome del gruppo di studio internazionale sulla SM pediatrica e secondo Polman [Polman 2011] allo Screening. La diagnosi di SMRR deve essere confermata da una scansione RMI del cervello eseguita entro i 12 mesi precedenti allo screening o allo Screening. 4. È stato determinato dal medico curante che il trattamento con natalizumab è appropriato per questo soggetto in base allo stato della malattia. 5. Soggetti in età fertile, che sono sessualmente attive, deve utilizzare un metodo contraccettivo efficace durante lo studio ed essere disposti e in grado di continuare la contraccezione per 3 mesi dopo la loro ultima infusione del trattamento in studio. Per ulteriori dettagli circa la necessità di utilizzare contraccettivi di questo studio, si prega di fare riferimento alla Sezione 15.5.3 del protocollo.
    E.4Principal exclusion criteria
    Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment or at the timepoint specified in the individual criterion listed:
    Medical History
    1. Diagnosis of acute disseminated encephalomyelitis, neuromyelitis optica, isolated optic neuritis or transverse myelitis, progressive MS, or any other potential differential diagnosis of pediatric-onset RRMS.
    2. History of human immunodeficiency virus.
    3. History of hepatitis C virus antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]). Subjects with immunity to hepatitis B from previous natural infection (defined asnegative HBsAg, positive hepatitis B surface antibody immunoglobulin G, and positive HBcAb) are eligible to participate in the study (US Centers for Disease Control and Prevention’s interpretation of the hepatitis B serology panel).
    4. History of or current signs and symptoms suggestive of PML.
    5. History of inflammatory disorders, metabolic neurogenetic leukodystrophies, toxic leukoencephalopathies, or vascular conditions.
    6. History of premalignant or malignant disease.
    7. History of severe allergic or anaphylactic reactions, or known drug hypersensitivity.
    8. Clinically significant infections or medical illness from 30 days prior to Screening or between Screening and the first infusion of study treatment.
    9. Diagnosis of MS relapse within 30 days prior to enrollment.
    10. History of, or abnormal laboratory values indicative of, significant medical, neurologic (other than MS), or psychiatric disorders that might preclude participation in the study in the opinion of the Investigator.
    11. Abnormal laboratory values at Screening defined at following thresholds:
    a. bilirubin level >2 times the upper limit of normal (× ULN)
    b. absolute lymphocyte count ≤750/mm3, hemoglobin ≤10 g/dL, or platelet count ≤100,000/mm3
    c. serum creatinine >1.5 mg/dL
    d. alanine aminotransferase (ALT), OR aspartate aminotransferase (AST), OR gamma-glutamyltransferase (GGT) >2 × ULN
    MS Treatment History
    12. Prior natalizumab therapy.
    13. Prior treatment with total lymphoid irradiation.
    14. Prior treatment with cladribine, mitoxantrone, fingolimod, teriflunomide, T cell or T-cell receptor vaccination, cyclophosphamide, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, or any therapeutic monoclonal antibody or other immunosuppressive therapy.
    15. Plasmapheresis or cytapheresis within 12 months prior to the first infusion of study treatment.
    16. Prior treatment with intravenous immunoglobulin (IVIg) within 4 months prior to the first infusion of study treatment.
    17. Treatment with IV or oral corticosteroids (topical corticosteroids are acceptable) or related products within 30 days prior to the first infusion of study treatment.
    18. Immunomodulatory treatment, i.e., interferon beta or glatiramer acetate within 2 weeks prior to the first infusion of study treatment.
    Miscellaneous
    19. Nursing or pregnant female, or female planning to become pregnant during study participation.
    20. Participation in any other investigational study that involved treatment with an investigational drug or prior treatment with any experimental agent outside a clinical study.
    21. Other unspecified reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment.
    I candidati saranno esclusi dell'ingresso nello studio se uno qualsiasi dei seguenti criteri di esclusione è presente al momento dell'arruolamento o al momento specificato nel singolo criterio elencato:
    Storia Medica
    1.Diagnosi di encefalomielite acuta disseminata, neuromielite ottica, neurite ottica isolata o mielite trasversale, sclerosi multipla progressiva, o di qualsiasi altra diagnosi potenziale differenziale di SMRR ad insorgenza pediatrica. 2. Storia di virus dell'immunodeficienza umana. 3. Storia di anticorpi contro il virus dell'epatite C o corrente infezione da epatite B (definiti come positivi per l'antigene di superficie dell'epatite B [HBsAg] e / o per l’anticorpo core dell'epatite B [HBcAb]). Soggetti con immunità per epatite B da precedenti infezioni naturali (definito come HBsAg negativo, anticorpo immunoglobulina G di superficie dell’epatite B positivo, e HBcAb positivo) sono idonei a partecipare allo studio (Centri statunitensi per il controllo delle malattie e l'interpretazione del pannello sierologico dell'epatite B per la prevenzione) . 4. Storia di/segni correnti e sintomi indicativi di PML. 5. Storia di malattie infiammatorie, leucodistrofie neurogenetiche metaboliche, leucoencefalopatie tossiche, o condizioni vascolari. 6. Storia di malattia pre-maligna o maligna. 7. Storia di gravi reazioni allergiche o anafilattiche, o ipersensibilità nota al farmaco. 8. Infezioni clinicamente significative o malattia medica da 30 giorni prima dello Screening o tra lo screening e la prima infusione del trattamento in studio. 9. La diagnosi di SM recidiva nei 30 giorni precedenti l'arruolamento. 10. Storia di/Valori di laboratorio anormali indicativi di una disturbi medici significativi, neurologici (diversi da MS), o psichiatrici che possono precludere la partecipazione allo studio a giudizio dello sperimentatore. 11. Valori di laboratorio anormali al momento dello screening definiti alle seguenti soglie: a. livello di bilirubina> 2 volte il limite superiore del valore normale (ULN) b. conta assoluta dei linfociti ≤ 750/mm3, emoglobina ≤ 10 g / dL, o conta piastrinica ≤ 100.000 / mm3 c. creatinina sierica> 1,5 mg / dL d. alanina aminotransferasi (ALT), o aspartato aminotransferasi (AST), o gamma-glutamiltransferasi (GGT)> 2 × ULN
    Storia del Trattamento della MS
    12. terapia precedente con natalizumab. 13. Precedenti trattamenti con irradiazione linfoide totale. 14. Un precedente trattamento con cladribina, mitoxantrone, fingolimod, teriflunomide, vaccinazione cellule T o recettore T-cellule, ciclofosfamide, ciclosporina, azatioprina, metotressato, micofenolato mofetile, o qualsiasi anticorpo monoclonale terapeutico o altre terapie immunosoppressive. 15. Plasmaferesi o citaferesi nei 12 mesi precedenti la prima infusione del trattamento in studio. 16. Un precedente trattamento con immunoglobuline per via endovenosa (IVIg) entro 4 mesi prima della prima infusione del trattamento in studio. 17. Il trattamento con corticosteroidi per via endovenosa o per via orale (corticosteroidi topici sono accettabili) o prodotti affini entro 30 giorni prima della prima infusione del trattamento in studio. 18. trattamento immunomodulante, vale a dire interferone beta o glatiramer acetato entro 2 settimane prima della prima infusione del trattamento in studio.
    Varie 19.Femmina incinta o in allattamento, o lche pianifica una gravidanza durante la partecipazione allo studio. 20. La partecipazione a qualsiasi altro studio sperimentale che ha coinvolto il trattamento con un farmaco sperimentale o un precedente trattamento con qualsiasi agente sperimentale al di fuori di uno studio clinico. 21. Altri motivi non precisati che, a giudizio del ricercatore e / o di Biogen Idec, rendono il soggetto non idoneo all’arruolamento.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are as follows: maximum plasma concentration (Cmax) for the 24-hour sampling period, predose (trough) concentrations (Cpredose) from multiple dosing time to maximum plasma concentration (Tmax) for the 24-hour sampling period area under the plasma concentration curve from time of first dose to infinity (AUCinf), apparent clearance (Cl/F), volume of distribution, elimination half-life (t1/2)

    Gli end point primari sono i seguenti: Concentrazione plasmatica massima (Cmax) per il periodo di campionamento di 24 ore, Concentrazioni pre-dose (minime) dal dosaggio multiplo (Cpre-dose), Tempo alla concentrazione plasmatica massima (Tmax) per il periodo di campionamento di 24 ore, Area sotto la curva di concentrazione plasmatica dal tempo della prima dose a infinito (AUCinf), Clearance apparente (Cl/F), Volume di distribuzione, Emivita di eliminazione (t1/2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoints are as follows: maximum plasma concentration (Cmax) for the 24-hour sampling period, predose (trough) concentrations (Cpredose) from multiple dosing time to maximum plasma concentration (Tmax) for the 24-hour sampling period area under the plasma concentration curve from time of first dose to infinity (AUCinf), apparent clearance (Cl/F), volume of distribution, elimination half-life (t1/2)

    Gli end point primari sono i seguenti: Concentrazione plasmatica massima (Cmax) per il periodo di campionamento di 24 ore, Concentrazioni pre-dose (minime) dal dosaggio multiplo (Cpre-dose), Tempo alla concentrazione plasmatica massima (Tmax) per il periodo di campionamento di 24 ore, Area sotto la curva di concentrazione plasmatica dal tempo della prima dose a infinito (AUCinf), Clearance apparente (Cl/F), Volume di distribuzione, Emivita di eliminazione (t1/2).
    E.5.2Secondary end point(s)
    The secondary endpoints are as follows: the average and minimum saturation values of α4 integrin over the dosing interval, incidence of serious adverse events (SAEs), infusion and hypersensitivity reactions, and other AEs, the presence of anti-natalizumab antibodies
    Gli end point secondari sono i seguenti: I valori di saturazione medi e minimi di integrina α4 nell’intervallo di dosaggio, L’incidenza di eventi avversi seri (SAE), reazioni all’infusione e di ipersensibilità e altri eventi avversi (EA), La presenza di anticorpi anti-natalizumab.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints are as follows: the average and minimum saturation values of α4 integrin over the dosing interval, incidence of serious adverse events (SAEs), infusion and hypersensitivity reactions, and other AEs, the presence of anti-natalizumab antibodies
    Gli end point secondari sono i seguenti: I valori di saturazione medi e minimi di integrina α4 nell’intervallo di dosaggio, L’incidenza di eventi avversi seri (SAE), reazioni all’infusione e di ipersensibilità e altri eventi avversi (EA), La presenza di anticorpi anti-natalizumab.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pediatric Pharmacokinetic Study
    Studio Pediatrico di Farmacocinetica
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned5
    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 years
    E.8.9.1In the Member State concerned months24
    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 Yes
    F.1.1Number of subjects for this age range: 12
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 6
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Ability of parents/legal guardians to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
    Capacità dei genitori/tutori legali di capire lo scopo,i rischi dello studio,fornire il consenso informato firmato,datato e l'autorizzazione all'uso delle informazioni sanitarie protette,in conformità con le normative nazionali sulla privacy
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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)
    Subjects who complete the PK/PD Study through Week 16 and for whom continued treatment with natalizumab is prescribed by their treating physician may continue uninterrupted treatment with natalizumab in either 1) the Italian National Registry or 2) the Extension Study.
    I soggetti che completano lo Studio PK-PD fino alla Settimana 16 e per i quali il medico curante ha prescritto la continuazione del trattamento con natalizumab possono continuare il trattamento ininterrotto con natalizumab nel 1. Registro nazionale italiano o nello 2. Studio di estensione.
    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 Decision2013-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-26
    P. End of Trial
    P.End of Trial StatusCompleted
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