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    Summary
    EudraCT Number:2012-000287-17
    Sponsor's Protocol Code Number:RC12-01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-06-18
    Trial 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 number2012-000287-17
    A.3Full title of the trial
    PROMOTION OF FUNCTIONAL RESTORATION THROUGH PHARMACOLOGICAL MODULATION OF BRAIN PLASTICITY WITH AMINOPYRIDINE IN PATIENTS WITH MULTIPLE SCLEROSIS STUDIED BY FUNCTIONAL MRI
    œPromozione del recupero funzionale mediante modulazione farmacologica della plasticita' cerebrale con Fampridina in pazienti con Sclerosi Multipla studiati con neuroimmagini funzionali
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    functional MRI study to evaluate improvement of hand performance after combined motor exercise and aminopiridine assumption
    Studio di risonanza Magnetica funzionale per valutare il miglioramento della performance motoria della mano dopo esercizio fisico associato ad assunzione di aminopiridina
    A.4.1Sponsor's protocol code numberRC12-01
    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 SponsorFONDAZIONE SANTA LUCIA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinistero della Salute
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFONDAZIONE SANTA LUCIA
    B.5.2Functional name of contact pointDIREZIONE SCIENTIFICA
    B.5.3 Address:
    B.5.3.1Street AddressVIA ARDEATINA, 306
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00179
    B.5.3.4CountryItaly
    B.5.4Telephone number00390651501504
    B.5.5Fax number00390651501408
    B.5.6E-mailDIREZIONE.SCIENTIFICA@HSANTALUCIA.IT
    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 Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical 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.3.9.4EV 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with MS, without relevant medical conditions, with right upper limb impairment assessed by a hand dexterity test will be included.Patients will be in a non-active phase of the disease and under a stable pharmacological treatment.They will not be included if they have received physiotherapy in the previous few months. Healthy volunteers will be recruited if they have no relevant medical condition and no contraindication to perform a MRI scan.
    Verranno inclusi pazienti con SM, senza altre patologie di rilievo, e con impaccio motorio dell’arto superiore dx quantificato da test di destrezza manuale. I pazienti saranno in fase non attiva di malattia e in trattamento farmacologico stabile nel periodo precedente e in corso di studio. Non dovranno aver effettuato fisioterapia nei mesi precedenti. I volontari sani non dovranno presentare patologie di rilievo e controindicazioni alla RM.
    E.1.1.1Medical condition in easily understood language
    MS patients with right upper limb impaired, non-active phase, stable pharmacological treatment and no physiotherapy.Healthy volunteers without medical condition and contraindication to MRI.
    Pazienti con SM e disabilita' in arto superiore dx,in fase non attiva,in terapia farmacologica stabile,non in fisioterapia.I volontari sani senza malattie di rilievo,ne' controindicazioni aRM
    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 LLT
    E.1.2Classification code 10028053
    E.1.2Term MS
    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
    1. To investigate the brain correlates of rehabilitation (rehab)-related clinical benefits on upper limb function in Multiple Sclerosis (MS) and to qualify imaging markers associated with performance improvements. Patterns of movement control can be adaptively driven by rehab through re-learning of lost function. Rehab-mediated improvements may be associated with brain functional changes in sensorimotor regions that can be measured with neuroimaging methods.

    2. To enhance rehab-mediated functional recovery in MS by pharmacological modulation of brain plasticity. Pharmacological modulation of brain plasticity aims to predispose sensorimotor systems to rehab effects, improving and prolonging rehab effect in MS. The association of a drug to physical intervention will test this hypothesis.
    1. Studiare i correlati cerebrali alla base del beneficio riabilitativo sulla funzione dell’arto superiore in SM e identificare marcatori di neuroimmagine associati con il miglioramento clinico.Modelli di controllo motorio possono essere promossi dalla riabilitazione con il ri-apprendimento di funzioni perse.I miglioramenti mediati dalla riabilitazione possono essere associati a modificazioni della funzione cerebrale misurabili nelle regioni sensorimotorie con metodi di neuroimmagine.
    2. Potenziare il recupero funzionale indotto da riabilitazione nella SM attraverso la modulazione farmacologica della plasticita' cerebrale. La modulazione farmacologica della plasticita' predispone i sistemi sensorimotori agli effetti benefici della riabilitazione, migliorando e prolungando gli effetti della riabilitazione nella SM.Questa ipotesi sara' valutata associando un farmaco alla terapia fisica.
    E.2.2Secondary objectives of the trial
    To test the indirect benefits of rehab alone and in associated with pharmacological treatment. For this purpose, clinical scales assessing cognitive functions, mood, anxiety and quality of life will be assessed. In the sub-study, the objective will be the characterisation and quantification of changes in brain activity induced by rehab alone and in association with pharmacological treatment.
    Testare il beneficio clinico indiretto della riabilitazione da sola e in associazione al trattamento farmacologico atraverso la somministrazione di scale cliniche volte a valutare aspetti diversi da quello motorio,quali le funzioni cognitive,il tono dell’umore e dell’ansia,e la qualita' di vita.
    Nell’ambito del sotto-studio elettrofisiologico,l’obiettivo consistera' nel caratterizzare e quantificare i cambiamenti dell’attivita' cerebrale indotti dalla terapia riabilitativa e dalla sua associazione con il trattamento farmacologico.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    EEffects of fampridine on cortical excitability(vers.1 3/3/2012)

    Evaluation of the effects of fampridine on cortical excitability through the use of neurophysiological methods.
    ALTRI SOTTOSTUDI:
    Effetti della Fampridina sulla eccitabilita' corticale (vers. 1 del 3/3/2012)

    Valutazione gli effetti della Fampridina sulla eccitabilita' corticale con l’utilizzo di metodiche neurofisiologiche
    E.3Principal inclusion criteria
    Right handed Multiple Sclerosis patients without relapses in the previous year and, if under pharmacological treatment, with a stable dose regimen for at least 3 months. Patients will be included if they present with a right hand dexterity impairment (average of 2 performances in 9-hole peg test: >30 seconds).
    Pazienti destrimani affetti da Sclerosi Multipla senza ricadute nell’anno precedente l’inclusione e, se in trattamento farmacologico, a regime terapeutico stabile da almeno 3 mesi. I pazienti dovranno presentare una disfunzione motoria dell’arto superiore destro (media di due tests del 9-pioli: &gt; 30 secondi).
    E.4Principal exclusion criteria
    Rehab in the previous 6 months; significant cognitive deficit that may prevent engagement in the study; contraindications to MRI scan; allergy to the drug or the eccipients; any relevant pathology that contraindicate drug intake.
    Terapia riabilitativa nei 6 mesi precedenti; deterioramento cognitivo significativo, tale da impedire la comprensione dello studio o la sua esecuzione; controindicazione all’effettuazione dell’esame di RM; allergia al principio attivo del farmaco o ad uno degli eccipienti; presenza di patologie di rilievo che controindichino la somministrazione del farmaco.
    E.5 End points
    E.5.1Primary end point(s)
    1. To establish the clinical benefit of rehab on right upper limb function and to identify imaging markers of clinical improvements. Rehab clinical benefits will be assessed using 9-hole peg test. MRI markers of clinical improvements will be identified through correlations between functional changes in patterns of brain activations and performance improvements.
    2. To establish the additional clinical benefit of the association of rehab with drug. This benefit will be tested in terms of (a) difference in clinical improvements between the group treated with rehab plus placebo and the group treated with rehab plus drug; (b) prolongation of rehab benefit measured as difference in performance changes during the follow-up with cessation of intervention.
    1. Stabilire un beneficio clinico della riabilitazione sulla destrezza dell’arto superiore destro e identificare marcatori di neuroimmagine di tale clinico beneficio. Il beneficio clinico verra’ misurato con il test del 9-pioli. L’identificazione dei marcatori di neuroimmagine avverra' attraverso la correlazione dei cambiamenti funzionali nelle attivazioni cerebrali con i miglioramenti clinici durante il periodo di intervento riabilitativo.
    3. Stabilire il beneficio clinico aggiuntivo dell’associazione farmaco-riabilitazione. Tale beneficio sara’ valutato in termini di (a) differenza di cambiamenti nella scala clinica (test dei 9-pioli) tra il gruppo trattato con riabilitazione e placebo e il gruppo trattato con riabilitazione e farmaco; (b) prolungamento nel tempo degli effetti benefici della riabilitazione in termini di differenza nei cambiamenti clinici tra i due gruppi, nel periodo di osservazione dopo la sospensione degli interventi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary end-points will be evaluated 6 weeks after the beginning of rehab and drug or placebo intake. At the end of the intervention period, patients will be evaluated after 6 weeks to test for prolongation of rehab benefit in the group treated with active drug.
    Gli end-points primari saranno valutati al termine delle 6 settimane di intervento, durante le quali i pazienti effettueranno riabilitazione e assumeranno farmaco placebo o farmaco attivo, e dopo un periodo di osservazione della durata di 6 settimane a partire dalla fine dell’intervento.
    E.5.2Secondary end point(s)
    Indirect clinical benefit of rehab in association with drug. This additional benefit will be assessed using quality of life (MSQoL-54), and mood and anxiety (Beck Depression Inventory Scale and STAI) tests.
    In those patients who will participate in the electrophysiological sub-study, changes in cortical activity resulting from association of rehab with drug will be tested.
    Beneficio clinico indiretto della riabilitazione associata con farmaco attivo. Tale beneficio sara' valutato con tests di qualita' di vita (MSQol-54), tono dell’umore e ansia (Beck Depression Inventory Scale e STAI).
    Nei pazienti che parteciperanno al sotto-studio elettrofisiologico verra' valutato il cambiamento dell’attivita' corticale indotto dall’associazione di terapia fisica e farmacologica.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end-points will be evaluated 6 weeks after starting rehab and drug intake. Patients will be also evaluated 6 weeks after rehab and drug intake cessation.
    In tutti i pazienti, gli end-points secondari saranno valutati al termine delle 6 settimane di riabilitazione e assunzione del farmaco, e poi dopo ulteriori 6 settimane dalla fine della terapia. tempistiche tempistiche.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other 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 Yes
    E.8.1.4Double blind No
    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 Yes
    E.8.2.3.1Comparator description
    presenza o meno di esercizio fisico
    presence or absence of physical exercise
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    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 months27
    E.8.9.1In the Member State concerned 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: 100
    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 Yes
    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 state100
    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)
    NA
    NA
    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 Decision2012-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
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