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    Summary
    EudraCT Number:2010-021978-11
    Sponsor's Protocol Code Number:101MS326
    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:2012-03-02
    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 number2010-021978-11
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS
    A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS
    A.3.2Name or abbreviated title of the trial where available
    101MS326
    101MS326
    A.4.1Sponsor's protocol code number101MS326
    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 LTD
    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 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 Limited
    B.5.2Functional name of contact pointnon disponibile
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone numbernon disponibile
    B.5.5Fax numbernon disponibile
    B.5.6E-mailascendspmsstudy@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*IV 1FL 300MG 15ML
    D.2.1.1.2Name of the Marketing Authorisation holderBIOGEN DOMPE' Srl
    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.3.4Pharmaceutical 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 INNNA
    D.3.9.1CAS number 189261-10-7
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple Sclerosis
    Sclerosi Multipla Progressiva Secondaria
    E.1.1.1Medical condition in easily understood language
    Disordine del sistema nervoso
    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 SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    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 investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in subjects with SPMS.
    L’obiettivo primario dello studio è di indagare se il trattamento con natalizumab rallenti l’accumulo di invalidità non correlata a recidive in soggetti con SPMS.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to determine in this study population: • the proportion of subjects with consistent improvement in Timed 25- foot Walk (T25FW) • the change in subject-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12) • the change in manual ability based on the ABILHAND Questionnaire • the impact of natalizumab on subject-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical) • the change in whole brain brain volume between the end of study and Week 24 using magnetic resonance imaging (MRI) • the proportion of subjects experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores
    Gli obiettivi secondari dello studio sono di determinare nella popolazione di questo studio: •la proporzione di soggetti con miglioramento consistente nel Timed 25-foot Walk (T25FW) •la variazione nello stato di deambulazione riportato dal soggetto misurata con la MS Walking Scale a 12 item (MSWS-12) •la variazione nell’abilità manuale in base al questionario ABILHAND •l’impatto di natalizumab sulla qualità della vita riportata dai soggetti usando la Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical) •la variazione nel volume dell’intero cervello tra la fine dello studio e la Settimana 24 usando la risonanza magnetica (RMI) •la proporzione di soggetti che accusa progressione dell’invalidità misurata con il sistema di punteggio individuale fisico Expanded Disability Status Scale (EDSS).
    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 national and local subject privacy regulations. 2. Be between the ages of 18 and 58, inclusive, at the time of informed consent. 3. Onset of SPMS at least 2 years prior to enrollment. SPMS is defined as relapsing-remitting disease followed by progression of disability independent of or not explained by MS relapses (Lublin, Reingold, 1996) ) for at least 2 years. 4. Have EDSS score of 3.0 to 6.5, inclusive. 5. Have an MS Severity Score (MSSS) of 4 or higher. 6. Have documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to enrollment as defined in the Study Reference Guide. 7. Subjects must have completed those baseline assessments associated with components of the primary endpoint (EDSS, T25FW, 9HPT) prior to randomization (Day 0). 8. Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last infusion.
    1. Capacità di comprendere lo scopo e i rischi associati allo studio, fornire un consenso informato datato e firmato e l’autorizzazione all’utilizzo di informazioni sanitarie protette (PHI) in conformità alle normative nazionali e locali riguardanti la privacy del soggetto. 2. Avere un’età compresa fra 18 e 58 anni inclusi, all’atto del consenso informato. 3. Insorgenza di SM-SP risalente ad almeno 2 anni prima dell’arruolamento. Per SM-SP si intende una patologia recidivante-remittente seguita da una progressione della disabilità indipendente o non spiegata da ricadute di SM (Lublin, Reingold, 1996) presente da un periodo minimo di 2 anni. 4. Avere un punteggio sulla scala EDSS (Expanded Disability Status Scale, Scala di Invalidità Espansa) compreso fra 3,0 e 6,5. 5. Avere un punteggio sulla scala MSSS (Multiple Sclerosis Severity Score, Punteggio di gravità di sclerosi multipla) pari a 4 o superiore. 6. Avere una prova confermata documentata della progressione della malattia indipendente da ricadute cliniche durante l’anno precedente all’arruolamento come definito nella Guida di riferimento allo studio. 7. I soggetti devono avere completato le valutazioni al basale associate ai componenti relativi all’endpoint primario (EDSS, T25FW, 9HPT) prima della randomizzazione (Giorno 0). 8. Durante la partecipazione allo studio i soggetti potenzialmente fertili devono adottare un efficace metodo di contraccezione ed essere disposti a proseguire il regime contraccettivo per 3 mesi dopo l’ultima infusione.
    E.4Principal exclusion criteria
    1.Have a diagnosis of RRMS or primary progressive MS as defined by the revised McDonald Committee criteria (Polman et al 2005). 2. Had a recent clinical relapse (within 3 months) prior to randomization. 3. Have a T25FW test of >30 seconds during the screening period. 4. Any value below the lower limit of normal for blood levels of leukocytes, lymphocytes, or neutrophils. 5. Considered by the Investigator to be immunocompromised based on medical history, physical examination, laboratory testing, or any other testing required by local guidelines, or due to prior immunosuppressive or immunomodulating treatment. 6. Subjects for whom MRI is contraindicated (i.e., have pacemakers or other contraindicated implanted metal devices, are allergic to gadolinium, or have claustrophobia that cannot be medically managed). 7. History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, and renal, or other major disease that would preclude participation in a clinical study. 8. History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).9. Known history of or positive test result for Human Immunodeficiency Virus (HIV). 10. Positive test result for hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surfaceantigen [HBsAg] and/or hepatitis B core antibody [HBcAb]). 11. History of transplantation or any anti-rejection therapy. 12. Presence of any infectious disease (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to screening. 13. History of PML or other opportunistic infections including active tuberculosis. Treatment History 14. Any prior treatment with cell-depleting therapies, including total lymphoid irradiation, cladribine, rituximab, alemtuzumab, or bone marrow ablation. 15. Any prior treatment with natalizumab. 16. Treatment with mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, T cell or T cell receptor vaccination, fingolimod, daclizumab, or cytapheresis within 6 months prior to randomization. 17. Treatment with IV or oral corticosteroids, intravenous immunoglobulin (IVIg), or plasmapheresis for treatment of MS within the 3 months prior to randomization. 18. Treatment with glatiramer acetate or any interferon beta preparations within 4 weeks prior to randomization. 19. Treatment with 4-aminopyridine within 30 days prior to randomization, unless a stable dose has been maintained for at least 30 days prior to randomization and will be continued for the course of this study. Miscellaneous 20. Female subjects considering becoming pregnant while in the study. 21. Female subjects of childbearing potential who have a positive pregnancy test at either the Screening Visit or Week 0. 22. Female subjects who are pregnant or currently breastfeeding. 23. History of drug or alcohol abuse, in the opinion of the Investigator, within 2 years prior to entry.
    1. Riportare una diagnosi di SM-RR o SM progressiva primaria come definito nei criteri rivisti del McDonald Committee (Polman et al 2005). 2. Avere avuto una recente ricaduta clinica (nei 3 mesi precedenti) rispetto al momento della randomizzazione. 3. Avere prodotto un risultato &gt;30 secondi nel test T25FW durante il periodo di screening. 4. Qualsivoglia valore al di sotto del limite della norma relativamente ai livelli nel sangue di leucociti, linfociti o neutrofili. 5. Essere considerato dallo Sperimentatore un soggetto immunocompromesso in base all’anamnesi, all’esame obiettivo, alle analisi di laboratorio o a qualsiasi altro esame richiesto dalle linee guida locali o in seguito a precedente trattamento immunosoppressivo o immunomodulante. 6. Soggetti nei quali la RMI sia controindicata (ovvero soggetti con impianto di pacemaker o altri dispositivi di metallo controindicati, soggetti allergici a gadolinio o affetti da claustrofobia non gestibile con terapie mediche). 7. Storia di qualsivoglia patologia cardiaca, endocrina, ematologica, epatica, immunologica, metabolica, urologica, polmonare, neurologica (diversa dalla SM), dermatologica, psichiatrica e renale o altra patologia importante clinicamente significativa (in base al giudizio dello Sperimentatore) che precluderebbe la partecipazione a uno studio clinico. 8. Storia di patologia maligna, inclusi tumori solidi e patologie ematologiche di natura maligna (a eccezione dei carcinomi della pelle a cellule basali e squamose che sono stati completamente asportati e considerati curati). 9. Storia pregressa di o positività al test per il virus dell’immunodeficienza umana (HIV). 10. Positività al test per il virus dell’epatite C (test per la ricerca dell’anticorpo al virus dell’epatite C [HCV Ab]) o virus dell’epatite B (test per la ricerca dell’antigene superficiale dell’epatite B [HBsAg] e/o dell’anticorpo core dell’epatite B [HBcAb]). 11. Storia di trapianto o qualsivoglia terapia antirigetto. 12. Presenza di qualsivoglia malattia infettiva (es., cellulite, ascesso, polmonite, setticemia) insorta nei 30 giorni precedenti allo screening. 13. Storia di leucoencefalopatia multifocale progressiva (LMP) o altre infezioni opportunistiche, inclusa la tubercolosi attiva. Storia del trattamento 14. Qualsivoglia precedente trattamento con terapia di deplezione cellulare, tra cui irradiazione linfoide totale, cladribina, rituximab, alemtuzumab o ablazione del midollo osseo. 15. Qualsivoglia precedente trattamento con natalizumab. 16. Trattamento con mitoxantrone, ciclofosfamide, ciclosporina, azatioprina, metotrexato, micofenolato mofetile, vaccinazione contro le cellule T o il recettore delle cellule T, fingolimod, daclizumab o citaferesi nei 6 mesi precedenti alla randomizzazione. 17. Trattamento con corticosteroidi per somministrazione e.v. o orale, immunoglobulina endovenosa (IVIg) o plasmaferesi per il trattamento della SM nei 3 mesi precedenti alla randomizzazione. 18. Trattamento con glatiramer acetato o qualsiasi preparato con interferone beta nelle 4 settimane precedenti alla randomizzazione. 19. Trattamento con 4-aminopiridina nei 30 giorni precedenti alla randomizzazione, salvo laddove sia stata mantenuta una dose stabile per almeno 30 giorni prima della randomizzazione che continuerà a essere assunta per l’intera durata dello studio. Varie 20. Soggetti femminili che pianifichino una gravidanza durante la partecipazione allo studio. 21. Soggetti femminili potenzialmente fertili che risultino positivi al test di gravidanza alla Visita di screening o alla Settimana 0. 22. Soggetti femminili in stato interessante o in allattamento. 23. Storia di abuso di sostanze stupefacenti o alcool, in base al giudizio dello Sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is a binary outcome of confirmed progressors or non-progressors of disability, where progressors are defined as subjects who meet at least one of the following criteria: • Confirmed progression in EDSS: EDSS score increased from baseline by at least 1 point if baseline EDSS ≤5.5 or by at least 0.5 points if baseline EDSS ≥6,confirmed at a second visit at least 6 months later • Confirmed progression in T25FW: Time taken for T25FW increased by at least 20% of the baseline walk, confirmed at a second visit at least 6 months later • Confirmed progression in 9HPT: Time taken for 9HPT increased by at least 20% of the time taken at baseline, confirmed at a second visit at least 6 months later. The progression in 9HPT can occur on either hand, but will have to be confirmed on the same hand.
    L’endpoint primario è un esito binario di progressori o non-progressori confermati di disabilità, laddove i progressori sono definiti come i soggetti che soddisfino almeno uno dei seguenti criteri: • Progressione confermata sulla scala EDSS: aumento del punteggio sulla scala EDSS rispetto al basale di almeno 1 punto se al basale risultava ≤5,5, o di almeno 0,5 punti se al basale risultava ≥ 6, confermato a una seconda visita almeno 6 mesi dopo • Progressione confermata nel test T25FW: aumento del tempo impiegato nel test T25FW del 20% almeno rispetto al basale, confermato a una seconda visita almeno 6 mesi dopo • Progressione confermata nel test 9HPT: aumento del tempo impiegato nel test 9HPT del 20% almeno rispetto al basale, confermato a una seconda visita almeno 6 mesi dopo. La progressione nel test 9HPT può manifestarsi su qualsiasi mano, ma la conferma dovrà essere effettuata sulla stessa mano.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 6 month intervals
    a intervalli semestrali
    E.5.2Secondary end point(s)
    The secondary endpoints for this study are as follows: • Percentage of T25FW responders (defined as any improvement from best pre-dose T25FW in at least 75% of the scheduled on-treatment visits through Week 96). • Change from baseline in MSWS-12 score to Week 96. • Change from baseline in ABILHAND Questionnaire scores to Week 96. • Change from baseline in MSIS-29-Physical score to Week 96. • Percentage change from Week 24 in whole brain volume at Week 96. • Percentage of subjects experiencing confirmed worsening in the individual EDSS Physical Functional System Scores where confirmed is defined as 2 examinations at least 6 months apart.
    • Percentuale dei soggetti rispondenti al T25FW (da intendersi come qualsiasi miglioramento rispetto al miglior T25FW pre-dose almeno nel 75% delle visite programmate durante il trattamento fino alla Settimana 96). • Variazione dal basale nel punteggio MSWS-12 alla Settimana 96. • Variazione dal basale nei punteggi relativi al questionario ABILHAND alla Settimana 96. • Variazione dal basale nel punteggio MSIS-29-Physical alla Settimana 96. • Variazione in percentuale dalla Settimana 24 nel volume cerebrale totale alla Settimana 96. • Percentuale di soggetti che manifestano un peggioramento confermato nei punteggi individuali relativi al sistema funzionale fisico sulla scala EDSS (individual EDSS Physical Functional System Scores), laddove per confermato si intendono 2 esami effettuati a distanza di 6 mesi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Percentage of T25FW responders (defined as any improvement from best predose T25FW in at least 75% of the scheduled on-treatment visits through Week 96) (every 3 months) • Change from baseline in MSWS-12 score to Week 96 (every 3 months) • Change from baseline in ABILHAND Questionnaire scores to Week 96 (every 3 months) • Change from baseline in MSIS-29-Physical score to Week 96 (every 6 months) • Percentage change from Week 24 in whole brain volume at Week 96 (every 6 months) • Percentage of subjects experiencing confirmed worsening in the individual EDSS Physical Functional System Scores.
    • Percentuale di soggetti rispondenti al T25FW (da intendersi come qualsiasi miglioramento rispetto al migliorT25FW pre-dose almeno nel 75% delle visite programmate durante il trattamento fino alla Settimana 96)(ogni 3 mesi) • Variazione dal basale nel punteggio MSWS-12 alla Settimana 96 (ogni 3 mesi)• Variazione dal basale nei punteggi relativi al questionario ABILHAND alla Settimana 96 (ogni 3 mesi)• Variazione dal basale nel punteggio MSIS-29-Physical alla Settimana 96 (ogni 6 mesi)• Variazione in percentuale dalla Settimana 24 nel volume cerebrale totale alla Settimana 96 (ogni 6 mesi) • Percentuale di soggetti che manifestano un peggioramentoconfermato nei punteggi individuali relativi al sistema funzionale fisico sulla scala EDSS.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA126
    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
    Canada
    Russian Federation
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of study is last subject, last visit for final collection of data.
    La fine dello studio è l' ultimo soggetto, l' ultima visita per la raccolta finale dei dati.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months57
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months57
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 856
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 506
    F.4.2.2In the whole clinical trial 856
    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)
    All subjects who complete this study according to the protocol and who are eligible may choose to be enrolled into an open label extension study in which all subjects will receive natalizumab. This extension study will be described under a separate protocol.
    Tutti i pazienti che completano questo studio in accordo al protocollo e che sono elegibili possono scegliere di essere arruolati nello studio di estensione in aperto nel quale tutti i soggetti riceveranno natalizumab. Questo studio di estensione sarà descritto in un protocollo separato.
    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 Decision2011-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-10-21
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