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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2011-006291-39
    Sponsor's Protocol Code Number:215ON201
    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:2012-10-26
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-006291-39
    A.3Full title of the trial
    A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With First Episode of Acute Optic Neuritis.
    Studio randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo, per valutare la efficacia, la sicurezza, la tollerabilita' e la farmacocinetica di BIIB033 in soggetti con primo episodio di neurite ottica acuta.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the safety and efficacy of BIIB033 to a placebo in patients with first episode of loss of vision due to acute inflammation in the optic nerve.
    Studio per valurare la sicurezza e l'efficacia di BIIB033 vs placebo in pazienti con primo episodio di 0perdita della visione dovuta ad infiammazione acuta del nervo ottico.
    A.4.1Sponsor's protocol code number215ON201
    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 RESEARCH 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 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 point215ON201 Clinical Trial Team
    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 number-
    B.5.5Fax number-
    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 nameNA
    D.3.2Product code BIIB033
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeBIIB033
    D.3.9.3Other descriptive nameHuman anti-LINGO-1 monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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. 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 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 placeboSolution 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
    Acute Optic Neuritis
    Neurite ottica acuta.
    E.1.1.1Medical condition in easily understood language
    Acute Optic Neuritis
    Neurite ottica acuta.
    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 10030942
    E.1.2Term Optic neuritis
    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 evaluate the efficacy of BIIB033 in subjects with their first episode of unilateral AON.
    L’obiettivo primario dello studio è di valutare l’efficacia di BIIB033 in soggetti con primo episodio di AON unilaterale.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study in this study population is to assess the safety, tolerability, and PK of BIIB033.
    L’obiettivo secondario di tale studio in questa popolazione di studio è di valutare la sicurezza, la tollerabilità e la farmacocinetica di BIIB033.
    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. Males and females with a confirmed diagnosis (by a physician with expertise in diagnosis and treatment of diseases of the optic nerve) of a first episode of unilateral AON with an onset within 28 days prior to study dosing at Day 1/Baseline. The diagnostic criteria of AON should include at least 2 of the following: reduced visual acuity, afferent pupillary defect, color vision loss, visual field abnormality, and/or pain on eye movement. Onset of ocular pain alone cannot be used to determine the onset of AON. Subjects are allowed to enroll regardless of if there are demyelinating lesions on brain MRI. 3. Aged 18 to 55 years old, inclusive, at the time of informed consent. 4. Must have received treatment of AON with 1 gram IV methylprednisolone for a minimum of 3 days and a maximum of 5 days prior to randomization. 5. All male or female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment.
    Criteri di inclusione 1. Capacità di comprendere lo scopo e i rischi dello studio e di fornire un consenso informato firmato e datato, nonché l’autorizzazione all’uso di informazioni sanitarie riservate (protected health information, PHI), conformemente alle leggi nazionali e locali sulla privacy del soggetto. 2. Soggetti maschili e femminili con diagnosi confermata (da un medico con esperienza in diagnosi e trattamento di malattie del nervo ottico) di primo episodio di neurite ottica acuta (Acute Optic Neuritis, AON) unilaterale, con insorgenza entro i 28 giorni che precedono il dosaggio dello studio al giorno 1/basale. I criteri diagnostici dell’AON devono comprendere almeno 2 dei seguenti sintomi: ridotta acuità visiva, difetto pupillare afferente, perdita della visione a colori, anomalie del campo visivo e/o dolore al movimento degli occhi. La comparsa del solo dolore oculare non può essere usata per determinare l’insorgenza dell’AON. Ai soggetti sarà consentito l’arruolamento a prescindere dalla presenza di lesioni demielinizzanti, individuate con RMI (risonanza magnetica per immagini) encefalica. 3. Di età compresa tra 18 e 55 anni, inclusi, al momento della firma del consenso informato. 4. Devono aver ricevuto il trattamento per l’AON con 1 grammo di metilprednisolone IV, per un minimo di 3 giorni e un massimo di 5 giorni prima della randomizzazione. 5. Tutti i soggetti di sesso maschile, e i soggetti di sesso femminile in età fertile devono adottare un metodo contraccettivo efficace nel corso dello studio ed essere disposti e in grado di proseguire con la contraccezione per almeno 6 mesi dopo l’assunzione dell’ultima dose del farmaco in studio.
    E.4Principal exclusion criteria
    1. Prior episode(s) of optic neuritis or any other previous clinical CNS demyelinating events characteristic of MS as determined by a physician with expertise in the diagnosis and treatment of MS. 2. Subjects with an established diagnosis of MS are excluded except if newly diagnosed based on the current episode of AON and positive brain MRI results consistent with the 2010 revisions to the McDonald's criteria. [Polman 2011]. 3. Severe refractive errors defined as myopia or hypermetropia of ±6 diopters sphere or worse in either eye. 4. Loss of vision not due to AON. 5. Previous history of, or current severe disc edema or hemorrhage. 6. Abnormal FF-VEP in the fellow eye at Screening as determined by the central reader. 7. Concomitant ophthalmologic disorders (e.g., diabetic retinopathy, macular degeneration, macular exudate, macular edema, glaucoma, severe astigmatism, ocular trauma, neuromyelitis optica, ischemic optic neuropathy, congenital nystagmus) or other ophthalmologic conditions that could interfere with the proposed protocol as determined by a physician with expertise in the diagnosis and treatment of ophthalmologic disorders. 8. History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, oncologic, renal, severe allergic or anaphylactic reactions, or other major disease, as determined by the Investigator. 9. Females who have a positive pregnancy test result, or who are pregnant, breastfeeding, or planning to conceive during the study. 10. History of positive test result for human immunodeficiency virus (HIV). 11. History of hepatitis C virus antibody (HCV Ab) or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]). 12. History or evidence of drug or alcohol abuse (as defined by the Investigator) within 2 years prior to Screening. 13. Current enrollment in any other study treatment or disease study within 3 months prior to Day 1/Baseline. 14. Participation in previous studies with BIIB033. 15. Inability to comply with study requirements. 16. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
    Criteri di esclusione 1. Episodio/i precedente/i di neurite ottica o un qualsiasi altro evento clinico di demielinizzazione del SNC (sistema nervoso centrale) caratteristico/i della SM identificato/i da un medico con esperienza in diagnosi e trattamento della SM. 2. I soggetti con una diagnosi accertata di SM (sclerosi multipla) sono esclusi, tranne se di nuova diagnosi sulla base dell’attuale episodio di AON e se risultati positivi a seguito di RMI encefalica, coerentemente con le revisioni del 2010 ai criteri di McDonald. [Polman 2011]. 3. Gravi errori refrattivi, definiti come miopia o ipermetropia di ± 6 diottrie sferiche o peggiori in entrambi gli occhi. 4. Perdita visiva non imputabile all’AON. 5. Anamnesi precedente o attuale di grave edema o emorragia del disco ottico. 6. FF-VEP (full field visual evoked potential, potenziale evocato visivo a campo intero) anomalo nell’occhio compagno allo screening, determinato con il lettore centrale. 7. Disturbi oftalmologici concomitanti (ad es. retinopatia diabetica, degenerazione maculare, essudato maculare, edema maculare, glaucoma, grave astigmatismo, trauma oculare, neuromielite ottica, neuropatia ottica ischemica, nistagmo congenito) o altre condizioni oftalmologiche, identificate da un medico con esperienza in diagnosi e trattamento di disturbi oftalmologici, che potrebbero interferire con il protocollo proposto. 8. Anamnesi di una qualsiasi clinicamente significativa malattia cardiaca, endocrinologica, ematologica, epatica, immunologica, metabolica, urologica, polmonare, neurologica, dermatologica, psichiatrica, oncologica, renale o gravi reazioni allergiche o anafilattiche oppure altra malattia principale, identificata dallo sperimentatore. 9. Donne con risultato positivo al test di gravidanza, o attualmente incinte, in allattamento o che stanno pianificando una gravidanza nel corso dello studio. 10. Anamnesi di sieropositività al virus dell’immunodeficienza umana (HIV). 11. Anamnesi di anticorpo del virus dell’epatite C (HCV Ab, hepatitis C virus antibody) o del virus dell’epatite B (definita da positività per l’antigene di superficie dell’epatite B [HBsAg, hepatitis B surface antigen] o per l’anticorpo core dell’epatite B [HBcAb, hepatitis B core antibody]). 12. Anamnesi o prova di abuso da alcol o dipendenza da droga (stabilito dallo sperimentatore) nell’arco dei 2 anni precedenti lo screening. 13. Attuale arruolamento in un qualsiasi altro trattamento in studio o studio di una malattia entro i 3 mesi che precedono il giorno1/basale. 14. Partecipazione a precedenti studi su BIIB033. 15. Incapacità a soddisfare tutte le esigenze dello studio. 16. Altri motivi non specificati che, a giudizio dello sperimentatore di Biogen Idec, non qualificano il soggetto per l’arruolamento.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint: Change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by full-field visual evoked potential (FF-VEP).
    Endpoint di efficacia primaria • Variazione della velocità di conduzione nervosa (nerve conduction velocity, NCV) del nervo ottico alla settimana 24 per l’occhio colpito, rispetto al basale e prendendo l’occhio compagno non colpito come riferimento, determinata dal potenziale evocato visivo a campo intero (full field visual evoked potential, FF-VEP).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Settimana 24
    E.5.2Secondary end point(s)
    -Change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by spectral-domain optical coherence tomography (SD-OCT). -Change in thicknesses of the retinal ganglion cell layer/inner plexiform retinal layer (RGCL/IPL) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SDOCT. -Change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low-contrast Sloan letter charts. Safety Endpoints: The following safety parameters will be used to address the safety and tolerability portion of the secondary objective: -Adverse events (AEs) and serious adverse events (SAEs) -Clinical laboratory results and vital sign measurements -Physical examination findings -Brain MRI results -12-lead electrocardiogram (ECG) readings -AON signs and symptoms PK Endpoint: The PK portion of the secondary objective will be addressed by a population PK assessment.
    Endpoint di efficacia secondaria • Variazione dello spessore dello strato delle fibre nervose della retina (retinal nerve fiber layer, RNFL) alla settimana 24 per l’occhio colpito, rispetto al basale e prendendo l’occhio compagno non colpito come riferimento, determinata con tomografia ottica a coerenza di fase a dominio spettrale (spectral domain optical coherence tomography, SD-OCT). • Variazione dello spessore dello strato di cellule del ganglio retinico/strato retinico del plessiforme interno (retinal ganglion cell layer, RGCL/inner plexiform retinal layer, ILP) alla settimana 24 per l’occhio colpito, rispetto al basale e prendendo l’occhio compagno non colpito come riferimento, determinata con SD-OCT. • Variazione dell’acuità con lettere a basso contrasto (low contrast letter acuity, LCLA) alla settimana 24 rispetto al basale, utilizzando le tabelle con le lettere di Sloan a basso contrasto, pari a 1,25% e 2,5%. Endpoint di sicurezza Per soddisfare la parte su sicurezza e tollerabilità dell’obiettivo secondario si adotteranno i seguenti parametri di sicurezza. • Eventi avversi (EA) ed eventi avversi gravi (EAG) • Risultati di laboratorio clinici e misurazione dei parametri vitali • Risultati dell’esame obiettivo • Risultati della risonanza magnetica per immagini (RMI) dell’encefalo • Rilevazioni dell’elettrocardiogramma a 12 derivazioni (ECG) • Segni e sintomi dell’AON. Endpoint PK La parte PK dell’obiettivo secondario sarà attuata tramite: • la valutazione PK della popolazione.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints: Week 24 Safety/PK endpoints: Throughout the course of the study
    Endpoints di efficacia: Settimana 24 Endpoints di sicurezza/farmacocinetica: nel corso dello studio.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 80
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 80
    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)
    Follow up treatment and care for the AON after completion of the study is not needed since AON is a monophasic disease. For subjects with
    AON who have multiple sclerosis or are considered to be at increased
    risk of developing multiple sclerosis, follow up will be done by a local
    neurologist. The study investigator will refer the patient to a
    neurologist if they don't already have one.
    Al termine dello studio la cura ed il trattamento della neurite ottica acuta non è necessario in quanto si tratta di una patologia monofasica. I soggetti che hanno la sclerosi multipla o sono considerati a rischio per tale patologia saranno seguiti dal neurologo. Se sprovvisti, lo sperimentatore indicherà ai pazienti un neurologo.
    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 Decision2013-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-21
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