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    Summary
    EudraCT Number:2011-003507-38
    Sponsor's Protocol Code Number:218MS403
    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:2012-03-02
    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 number2011-003507-38
    A.3Full title of the trial
    An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily
    on Quality of Life as Reported by Subjects with Multiple Sclerosis
    Studio multicentrico, multinazionale, in aperto per valutare l'effetto a lungo termine di fampridina a rilascio prolungato (BIIB041) 10 mg due volte al giorno sulla qualita' di vita riferita da soggetti con sclerosi multipla
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-Term Prolonged-Release Fampridine Treatment and Quality of Life
    Trattamento e qualita' della vita a lungo termine di fampridina e rilascio prolungato
    A.4.1Sponsor's protocol code number218MS403
    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 pointnd
    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 numberND
    B.5.5Fax numberND
    B.5.6E-mailenablestudy@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 Fampyra
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec Limited
    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.3.4Pharmaceutical form Prolonged-release tablet
    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 INNFAMPRIDINE
    D.3.9.1CAS number 504-24-5
    D.3.9.2Current sponsor codeBIIB041
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB07505MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple Sclerosis
    Sclerosi multipla
    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 10028245
    E.1.2Term 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 effect of long-term treatment with prolonged-release fampridine 10 mg twice daily on the physical component scale (PCS) of the Short Form (36) Health Status Questionnaire (SF-36) as reported by treatment responders.
    L'obiettivo primario dello studio è di valutare l'effetto del trattamento a lungo termine con fampridina a rilascio prolungato 10 mg, due volte al giorno, sulla scala della salute fisica (PCS, physical component scale) presente nel questionario in forma breve (36) sullo stato di salute (SF36), il Short Form (36) Health Status Questionnaire (SF36), in base a quanto riferito dai soggetti rispondenti al trattamento.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are as follows: 1) Compare the change in the PCS of the SF-36 between treatment responders and non-responders (treatment discontinued at Week 4). 2)Evaluate change from baseline in additional QoL measures among treatment responders as well as changes from baseline in treatment responders versus non-responders. 3)Assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily.
    Gli obiettivi secondari dello studio sono i seguenti: •Confrontare la variazione nella PCS dell'SF36 tra i soggetti rispondenti e quelli non rispondenti al trattamento (trattamento sospeso in Settimana 4). •Valutare la variazione rispetto al basale delle misurazioni aggiuntive sulla QdV effettuate tra i soggetti rispondenti al trattamento, così come le variazioni rispetto al basale dei soggetti rispondenti al trattamento verso quelli non rispondenti. •Valutare la sicurezza e la tollerabilità della fampridina a rilascio prolungato 10 mg due volte al giorno.
    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 Screening Visit or at the timepoint specified in the individual eligibility criterion listed: 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. Male or female subjects, 18 to 75 years old, inclusive, at the time of informed consent. 3. Must have a diagnosis of primary-progressive, secondary-progressive, progressive-remitting, or relapsing-remitting MS per revised McDonald Committee criteria (Section 22.1 [Polman et al, 2011]) as defined by Lublin and Reingold [Lublin and Reingold 1996] of at least 3 months duration. 4. Have a walking impairment as determined by the Investigator. 5. Able to perform the T25FW (Section 22.2) test with or without a walking aid. 6. Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. 7. Able to understand and comply with the requirements of the protocol.
    Per essere idonei a partecipare allo studio i pazienti dovranno soddisfare i seguenti criteri di inclusione alla visita di screening o al momento specificato nel criterio di inclusione listato: 1. Capacità di comprendere il proposito e i rischi dello studio e fornire il consenso informato firmato e l’autorizzazione all’uso dei dati personali in accordo con la legislazione nazionale in materia di privacy. 2. Maschi o femmine dai 18 ai 75 anni compresi, al momento della firma del consenso informato. 3. Pazienti che hanno una diagnosi di sclerosi multipla primaria progressiva, secondaria progressiva, progressiva-remittente o recidivante-remittente secondo i criteri rivisti dal Comitato McDonald (Section 22.1 [Polman et al, 2011]) come definita da Lublin and Reingold [Lublin and Reingold 1996] della durata di almeno 3 mesi. 4. Pazienti che hanno difficoltà deambulatorie come determinate dallo Sperimentatore. 5. Pazienti capaci di effettuare il test T25FW (Section 22.2) con o senza un aiuto per camminare 6. Donne potenzialmente fertili devono utilizzare un efficace metodo contraccettivo durante lo studio e per 30 giorni dopo l’ultima dose del farmaco in studio. 7. Pazienti capaci di comprendere e attenersi alle richieste del protocollo.
    E.4Principal exclusion criteria
    Candidates will be excluded from study entry if any of the following exclusion criteria are met at the Screening Visit or at any time during the screening period, or at the timepoint specified in the individual eligibility criterion listed: Medical History 1. Known allergy to pyridine-containing substances or to any of the inactive ingredients (see Section 12.1) in the prolonged-release fampridine tablet. 2. Any history of seizure, epilepsy, or other convulsive disorder, with the exception of febrile seizures in childhood. 3. An estimated CrCl of <80 mL/minute. 4. Subject needs to take medicinal products that are inhibitors of organic cation transporter 2 (OCT2 [e.g., cimetidine]). Miscellaneous 5. Female subjects who are currently pregnant or who are considering becoming pregnant while participating in the study. Female subjects of childbearing potential who have a positive pregnancy test at the Screening Visit may not participate in this study. 6. Female subjects who are currently breastfeeding. 7. Previous exposure to fampridine.
    I candidati saranno esclusi dalla partecipazione allo studio se uno qualsiasi dei seguenti criteri di esclusione sia presente alla visita di screening o in qualsiasi momento durante il periodo di screening, o al momento specificato nel criterio di inclusione individuale elencato: Storia medica 1. Allergia nota a sostanze contenenti piridina o ad uno qualsiasi degli eccipienti (vedi sezione 12.1) nella compressa di fampridina a rilascio prolungato. 2. Una storia di convulsioni, epilessia o altri disturbi convulsivi, ad eccezione di convulsioni febbrili nell'infanzia. 3.Una CrCl stimata &lt;80 ml/minuto. 4.Il soggetto ha bisogno di prendere medicinali che sono inibitori del trasportatore cationico organico 2 (OCT2 [ad esempio, cimetidina]). Varie: 5. Soggetti di sesso femminile che sono attualmente in stato di gravidanza o che stanno considerando di rimanere incinta durante la partecipazione allo studio. Soggetti di sesso femminile in età fertile che hanno un test di gravidanza positivo alla visita di screening non possono partecipare a questo studio. 6. Soggetti di sesso femminile che attualmente allattano al seno. 7. Precedente esposizione alla fampridina.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in the PCS of the SF-36 measured over Months 3, 6, 9, and 12 among subjects who respond to treatment with prolongedrelease fampridine.
    Variazione rispetto al basale della PCS dell'SF36 misurato nei Mesi 3, 6, 9 e 12 nei soggetti rispondenti al trattamento con fampridina a rilascio prolungato.
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline and week 12, 24, 36, 48 and 50
    Basale e settimane 12, 24, 36, 48 e 50
    E.5.2Secondary end point(s)
    1)Comparison of the change from baseline in the PCS of the SF-36 measured over Months 3, 6, 9, and 12 among subjects who respond to treatment with prolonged-release fampridine and those who do not. 2)Change from baseline in additional QoL measures over Months 3, 6, 9, and 12 among responders as well as comparisons in change from baseline between responders and non-responders: -Total and mental component scale (MCS) of the SF-36 -Multiple Sclerosis Impact Scale (MSIS-29) Physical and Psychological Score -Activities Limitation scale of the Patient-Reported Indices for Multiple Sclerorsis (PRIMUS) -EuroQoL descriptive system of health-related quality of life states consisting of 5 dimensions (questionnaire; EQ-5D) -Work Productivity and Activity Impairment (WPAI)-Specific Health Problem (SHP) questionnaire 3)Change in QoL measures among responders stratified by disease type. 4)Change in QoL measures between responders and non-responders not taking additional MS therapy. 5)Safety of prolonged-release fampridine will be assessed by: -the number and proportion of subjects with adverse events (AEs) and serious adverse events (SAEs)
    •Confronto della variazione rispetto al basale della PCS dell'SF36 misurato nei Mesi 3, 6, 9 e 12 nei soggetti rispondenti al trattamento con fampridina a rilascio prolungato e quelli non rispondenti. •Variazione rispetto al basale delle misurazioni aggiuntive sulla QdV nei Mesi 3, 6, 9 e 12 nei soggetti rispondenti al trattamento, così come confronti delle variazioni rispetto al basale tra i soggetti rispondenti al trattamento e quelli non rispondenti: -Scala della salute mentale (MCS, mental component scale) e totale dell'SF36 -Punteggio fisico e psicologico nella Scala d'impatto della sclerosi multipla (MSIS29, Multiple Sclerosis Impact Scale) -Scala della limitazione delle attività in base agli indici riferiti dal paziente per la sclerosi multipla (PRIMUS, Patient-Reported Indices for Multiple Sclerosis) -Sistema descrittivo EuroQoL sugli stati della qualità di vita in relazione alla salute, consistente in 5 dimensioni (questionario; EQ5D) -Questionario sul problema di salute specifico (SHP, Specific Health Problem) nella compromissione dell'attività e della produttività lavorativa (WPAI, Work Productivity and Activity) •Variazione nelle misurazioni sulla QdV tra i soggetti rispondenti al trattamento, stratificati per tipo di patologia. •Variazione nelle misurazioni sulla QdV tra i soggetti rispondenti al trattamento e quelli non rispondenti, non sottoposti a terapia aggiuntiva per la SM. •La sicurezza della fampridina a rilascio prolungato sarà valutata tramite: -il numero e il rapporto di soggetti con eventi avversi (EA) ed eventi avversi gravi (EAG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1)baseline and week 12, 24, 36, 48 and 50 2)baseline and week 12, 24, 36, 48 and 50 3)baseline and week 12, 24, 36, 48 and 50 4)baseline and week 12, 24, 36, 48 and 50 5)Throughout the study
    1)basale e settimane 12, 24, 36, 48 e 50 2)basale e settimane 12, 24, 36, 48 e 50 3)basale e settimane 12, 24, 36, 48 e 50 4)basale e settimane 12, 24, 36, 48 e 50 5)per tutta la durata 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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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
    Australia
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned 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: 640
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state53
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 730
    F.4.2.2In the whole clinical trial 800
    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)
    No further provisions are made for access to the study treatment
    Non sono previste ulteriori disposizioni per l'accesso al trattamento in studio
    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 Decision2012-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-12
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