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    Summary
    EudraCT Number:2010-021850-20
    Sponsor's Protocol Code Number:LMS-002
    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:2012-03-07
    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 number2010-021850-20
    A.3Full title of the trial
    A Phase 3, Multicenter, Double-blind, Placebo-controlled Randomized Discontinuation Study Followed by an Open-label Extension Period to Evaluate the Efficacy and Safety of Amifampridine Phosphate (3,4-Diaminopyridine Phosphate) in Patients with Lambert-Eaton Myasthenic Syndrome (LEMS)
    Studio randomizzato di sospensione di Fase 3, multicentrico, in doppio cieco, controllato con placebo, seguito da un periodo di estensione in aperto volto aHa valutazione dell'efficacia e della sicurezza dell'amifampridina fosfato (fosfato di 3,4-diaminopiridina) in pazienti affetti dalla sindrome miastenica di Lambert-Eaton (LEMS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 placebo controlled study to evaluate safety and efficacy of Amifampridine phosphate.
    Studio di Fase 3,controllato verso placebo, volto alla valutazione dell’efficacia e della sicurezza dell’amifampridina fosfato
    A.4.1Sponsor's protocol code numberLMS-002
    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 SponsorBIOMARIN PHARMACEUTICAL INC.
    B.1.3.4CountryUnited States
    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 supportBioMarin Pharmaceutical Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioMarin Pharmaceutical Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address105 Digital Drive
    B.5.3.2Town/ cityNovato, CA
    B.5.3.3Post code94949
    B.5.3.4CountryUnited States
    B.5.4Telephone numberna
    B.5.5Fax number+1.415-382-7889
    B.5.6E-mailclinicaltrials@bmrn.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 FIRDAPSE 10mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBioMarin Europe 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/02/124
    D.3 Description of the IMP
    D.3.4Pharmaceutical form 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 INNAMIFAMPRIDINE
    D.3.9.1CAS number 446254-47-3
    D.3.9.2Current sponsor codeBioMarin Part Number: T1801,
    D.3.9.3Other descriptive name3,4-DAP
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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 placeboTablet
    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
    Lambert-Eaton Myasthenic Syndrome (LEMS)
    sindrome miastenica di Lambert-Eaton (LEMS)
    E.1.1.1Medical condition in easily understood language
    Lambert-Eaton myasthenic syndrome (LEMS) in adults is a disease in which patients have muscle weakness
    lA sindrome miastenica di Lambert-Eaton (LEMS)negli adulti e' un patologia che provoca nei pazienti debolezza muscolare
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10028415
    E.1.2Term Myasthenia
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy: To compare the efficacy of amifampridine phosphate versus placebo on muscle strength in patients with LEMS at the end of a 14-day discontinuation period Safety: To assess the safety, including the long-term safety, of amifampridine phosphate in patients with LEMS.
    Efficacia: confrontare l’efficacia dell’amifampridina fosfato rispetto al placebo sulla forza muscolare di pazienti effetti da LEMS al termine di un periodo di sospensione della terapia di 14 giorni Sicurezza: Valutare la sicurezza, compresa quella a lungo termine, dell’amifampridina fosfato in pazienti affetti da LEMS
    E.2.2Secondary objectives of the trial
    The secondary objective is to compare the efficacy of amifampridine phosphate versus placebo on walking speed in patients with LEMS at the end of a 14-day discontinuation period The tertiary objectives are to compare the efficacy of amifampridine phosphate versus placebo on the following parameters in patients with LEMS at the end of a 14-day discontinuation period CMAP: amplitude: CGI-S: Investigator-perceived improvement in illness severity; CGI-I: Investigator-perceived global improvement or change; SGI: Subject global impression of improvement The exploratory objectives are to confirm the exposure of amifampridine and its major metabolite, 3-N-acetyl amifampridine, based on plasma concentrations in the LEMS patient population. To evaluate the relationship between NAT genetic polymorphism status and plasma levels of amifampridine and 3-N-acetyl amifampridine in LEMS patients
    L’obiettivo secondario e diconfrontare l’efficacia dell’amifampridina fosfato rispetto al placebo sulla velocita' di deambulazione di pazienti affetti da LEMS al termine di un periodo di sospensione della terapia di 14 giorni Gli obiettivi terziari sono di confrontare l’efficacia di amifampridina fosfato rispetto al placebo sui seguenti parametri in pazienti affetti da LEMS al termine di un periodo di sospensione della terapia di 14 giorni CMAP: ampiezza; CGI-S: miglioramento della gravita' della malattia percepito dallo sperimentatore; CGI-I: miglioramento o cambiamento globale percepito dallo sperimentatore; SGI: impressione globale del miglioramento da parte del soggetto. Gli obiettivi esplorativi sono di confermare l’esposizione all’amifampridina e al suo metabolita principale, 3-N-acetil amifampridina, in base alle concentrazioni plasmatiche nella popolazione di pazienti affetti da
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENETIC:
    Vers:finale
    Date:2011/04/19
    Title:A Phase 3, Multicenter, Double-blind, Placebo-controlled Randomized Discontinuation Study Followed by an Open-label Extension Period to Evaluate the Efficacy and Safety of Amifampridine Phosphate (3,4-Diaminopyridine Phosphate) in Patients with Lambert-Eaton Myasthenic Syndrome (LEMS)
    Objectives:To evaluate the relationship between NAT genetic polymorphism status and plasma levels of amifampridine and 3-N-acetyl amifampridine in LEMS patients

    PHARMACOKINETIC/PHARMACODYNAMIC:
    Vers:
    Date:
    Title:A Phase 3, Multicenter, Double-blind, Placebo-controlled Randomized Discontinuation Study Followed by an Open-label Extension Period to Evaluate the Efficacy and Safety of Amifampridine Phosphate (3,4-Diaminopyridine Phosphate) in Patients with Lambert-Eaton Myasthenic Syndrome (LEMS)
    Objectives:Exploratory PK of amifampridine and 3-N-acetyl metabolite in plasma will be conducted in the LEMS patient population. The relationship between NAT genetic status and exposure to amifampridine and 3-N-acetyl metabolite will be evaluated and described.
    FARMACOGENETICA:
    Vers:finale
    Data:2011/04/19
    Titolo:Studio randomizzato di sospensione di Fase 3, multicentrico, in doppio cieco, controllato con placebo, seguito da un periodo di estensione in aperto volto alla valutazione dell’efficacia e della sicurezza dell’amifampridina fosfato (fosfato di 3,4-diaminopiridina) in pazienti affetti dalla sindrome miastenica di Lambert-Eaton (LEMS)
    Obiettivi:valutazione della relazione tra lo stato NAT polimorfismo genetico e livelli plasmatici di amifampridine e amifampridine 3-N-acetil nei pazienti LEMS

    FARMACOCINETICA/FARMACODINAMICA:
    Vers:
    Data:
    Titolo:Studio randomizzato di sospensione di Fase 3, multicentrico, in doppio cieco, controllato con placebo, seguito da un periodo di estensione in aperto volto alla valutazione dell’efficacia e della sicurezza dell’amifampridina fosfato (fosfato di 3,4-diaminopiridina) in pazienti affetti dalla sindrome miastenica di Lambert-Eaton (LEMS)
    Obiettivi:Sarà valutata la farmacocinetica plasmatica esplorativa dell’amifampridina e del metabolita 3-N-acetil nella popolazione di pazienti affetti da LEMS. Sarà esaminata e descritta la correlazione tra stato
    genetico di NAT ed esposizione ad amifampridina e metabolita 3-N-acetil.
    E.3Principal inclusion criteria
    ≥18 years of age. - Confirmed diagnosis of LEMS as documented by acquired (typical) proximal muscle weakness and at least 1 of the following: Nerve conduction findings (CMAP that increases at least 2-fold after maximum voluntary contraction of the tested muscle) Positive anti-P/Q type voltage-gated calcium-channel antibody test - If currently receiving treatment with amifampridine for LEMS, a normal resp function as deined by an FVC >= 80% of predicted - If not currently receving amifampridine and pt has no history of othr current respiratory disease a FVC >= 60& i predicted- Completion of anti-cancer treatment at least 3 months (90 days) prior to Screening - A QMG score of ≥ 5 is required for patients without any prior symptomatic treatment for LEMS - If currently receiving treatment for LEMS, patients must present with some signs and/or symptoms consistent with LEMS - Normal respiratory function as defined by a forced vital capacity > 80% predicted (score of 0 on this dimension of QMG) - Normal swallowing function as defined by the ability to swallow 4 ounces of water without coughing or throat clearing (score of 0 on this dimension of QMG) - If receiving peripherally acting cholinesterase inhibitors (eg, pyridostigmine), a stable dose of cholinesterase inhibitors is required for at least 7 days prior to Screening - If receiving permitted oral immunosuppressants (eg, prednisone or other corticosteroid, azathioprine, mycophenolate), a stable dose is required for at least 90 days prior to Screening - Negative pregnancy test for females of childbearing potential at Screening - If sexually active, willing to use 2 acceptable methods of contraception from Screening until 3 months after the last dose - Willing to perform all study procedures as physically possible - Willing and able to provide written informed consent after the nature of the study has been explained and prior to the start of any research-related procedures.
    Eta' ≥18 anni - Diagnosi confermata di LEMS documentata da debolezza muscolare prossimale acquisita (tipica) e almeno 1 delle situazioni seguenti: Risultati della conduzione nervosa (CMAP che aumenta almeno del doppio dopo contrazione volontaria massima del muscolo esaminato) and Test positivo per l’anticorpo anti canali di calcio voltaggio-dipendenti di tipo P/Q - Completamento di terapia antitumorale almeno 3 mesi (90 giorni) prima dello Screening - E' necessario un punteggio QMG ≥ 5 nel caso dei pazienti senza alcuna previa terapia sintomatica per la LEMS - Se attualmente in terapia per la LEMS, i pazienti devono presentare alcuni segni e/o sintomi compatibili con la LEMS - Se il paziente sta ricevendo il trattamento con amifampridina per la LEMS, una funzionalita' respiratoria normale definita da una capacita' vitale forzata &gt; (FVC) ≥ 80% del valore previsto. - Se il paziente non sta ricevendo il trattamento con amifampridina per la LEMS e non ha una storia di QMG)altre malattie respiratorie in corso, una FVC ≥ 60% del valore previsto. Deglutizione normale definita come una capacita' di deglutire 115 ml di acqua senza tossire o schiarirsi la gola (punteggio pari a 0 in questa dimensione del QMG) - Se in terapia con inibitori della colinesterasi ad azione periferica (es. piridostigmina), e' richiesta una dose stabile da almeno 7 giorni prima dello Screening - Se in terapia con immunosoppressori orali permessi (es. prednisone o altri corticosteroidi, azatioprina, micofenolato), e' necessaria una dose stabile da almeno 90 giorni prima dello Screening - Test di gravidanza negativo allo Screening per le donne potenzialmente fertili - Se sessualmente attivi, disposti a usare 2 metodi contraccettivi accettabili a partire dallo Screening fino a 3 mesi dopo l’ultima dose -Disposti a sottostare a tutte le procedure di studio per quanto fisicamente possibile - Disposti e in grado di fornire il consenso informato scritto dopo aver ricevuto spiegazioni sulla natura dello studio e prima di iniziare qualsiasi procedura correlata alla ricerca.
    E.4Principal exclusion criteria
    History of epilepsy or seizure - Known active brain metastasis - cuncurrent use of fampridine and ay other 3,4 diaminopridine other than IP provided - - Use of medications known to lower the epileptic threshold within 7 days or 5 half-lives, whichever is longer, prior to Screening - Use of medications which inhibit neuromuscular junction function within 7 days or 5 half-lives, whichever is longer, prior to Screening - Use of IVIG, plasmapheresis (plasma exchange), or immunoadsorption within 90 days prior to Screening - Use of guanidine hydrochloride within 7 days of Screening - Use of rituximab within 12 months prior to Screening - History of drug allergy to any pyridine-containing substances or any amifampridine phosphate excipient(s) - Use of any other investigational product other than amifampridine phosphate or investigational medical device within 30 days prior to Screening or requirement for any investigational agent prior to completion of all scheduled study assessments - Treatment with a concomitant medication that prolongs the QT wave QT/QTc wave corrected for heart rate (QTc) interval within 7 days or 5 half-lives, whichever is longer, prior to Screening - Treatment with sultopride within 7 days prior to Screening - sinus arrhythmias - excessive heart rate variation at rest -QT wave corrected for heart rate using Bazzzatt`s formula (QTBC) interval > 450 msec confirmed by a rpeat ECG - PR inteval > 210 msec - QRS interval > 120 msec - Early polarisation pattern that increase the risk of partecipating in the study - Documented history of arrhythmias - Breastfeeding or pregnant at Screening or planning to become pregnant (self or partner) at any time during the study. Male patients with breastfeeding partners are not excluded from the study - Likely or expected to require treatment for cancer within 3 months (90 days) after entering Screening - History of severe renal impairment or evidence of severe renal impairment on Screening laboratory tests- Screening laboratory tests for hepatic impairment; In pt with without cancer , ALT, AST and or total bilirubin >ULN - in pt with cancer ALT, AST > 5xupper limit of normal (ULN) and or total bilirubin > 3 x ULN History of uncontrolled asmtma - Basline vital capacity < 1500 ml
    Anamnesi di epilessia o convulsioni - Metastasi cerebrali attive accertate Uso di fampridina - Uso concomitante di fampridina (4-amminopiridina) e di qualsiasi forma di 3,4-diamminopiridina a parte il farmaco sperimentale fornito, per esempio amifampridina base o Firdapseļƒ” durante lo studio. - Uso di farmaci noti per abbassare la soglia epilettica entro 7 giorni o 5 emivite, a seconda di quale periodo e' piu' lungo, prima dello Screening - Uso di farmaci che inibiscono la funzione della giunzione entro 7 giorni o 5 emivite, a seconda di quale periodo e' piu' lungo, prima dello Screening - Uso di IVIG, plasmaferesi (scambio plasmatico) o immunoadsorbimento entro 90 giorni prima dello Screening - Uso di guanidina cloridrato entro 7 giorni dallo Screening - Uso di rituximab entro 12 mesi prima dello Screening - Anamnesi di allergia a farmaci per qualsiasi sostanza contenente piridina o uno qualsiasi degli eccipienti dell’amifampridina fosfato - Uso di qualsiasi prodotto sperimentale (diverso da amifampridina base o fosfato) o di un dispositivo medico sperimentale entro 30 giorni prima dello Screening o necessita' di un agente sperimentale di qualsiasi tipo prima del completamento di tutte le valutazioni di studio previste. - Trattamento concomitante con un farmaco che prolunga l’intervallo QT/QTc entro 7 giorni o 5 emivite, a seconda di quale periodo e' piu' lungo, prima dello Screening - Trattamento con entro 7 giorni prima dello Screening - Un elettrocardiogramma (ECG) allo Screening che a parere dell’esame del cardiologo esterno indica quanto segue: aritmia sinusale con variabilita' della frequenza non accettabile (es. variabilita' RR &gt; 20%); Variazione eccessiva della frequenza cardiaca a riposo; intervallo QTcB &gt; 450 msec confermata da un secondo ECG; intervallo PR &gt; 210 msec; Intervallo QRS &gt; 120 msec se di eta' pari o inferiore a 35 anni o &gt; 110 msec se di eta' superiore a 35 anni; Pattern di ripolarizzazione precoce che aumenta il rischio durante la partecipazione allo studio Anamnesi documentata di aritmie - Paziente che allatta al seno o in stato di gravidanza allo Screening o che ha in programma una gravidanza (propria o della partner) in qualsiasi momento durante lo studio. I pazienti maschi con partner che allattano al seno non sono esclusi dallo studio -Probabile o previsto trattamento antitumorale entro 3 mesi (90 giorni) dopo l’ingresso nello Screening - Anamnesi di grave insufficienza renale o evidenza di grave insufficienza renale nelle analisi di laboratorio allo Screening - Analisi di laboratorio allo Screening per insufficienza epatica; - Storia di asma non controllato. Ai pazienti deve essere chiesto esplicitamente nell`ambito del colloquio di screening per l`ingresso nello studio se hanno mai avuto l`asma. I pazienti con storia di asma lieve o moderato sono ammessi purche' siano informati del fatto che sono state segnalate esacerbazioni dell`asma in seguito al trattamento con amifampridina. -Capacita' vitale (VC) basale &lt; 1500 mL.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change from baseline to Day 14 in QMG score
    L’endpoint di efficacia primario e' la variazione dal basale al Giorno 14 del punteggio QMG
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Open-label Run-in 7 – 91 Days - Double-blind Treatment Discontinuation Day 1 - Double-blind Treatment Days 8 to 14
    - Run In in aperto (giorni 7-91) - Sospensione del Trattamento in Doppio Cieco Giorno 1 -Trattamento in Doppio Cieco Giorno 8 e 14
    E.5.2Secondary end point(s)
    The secondary efficacy endpoint is the change from baseline to Day 14 in walking speed assessed by the T25FW test.
    L’endpoint di efficacia secondario e' la variazione dal basale al Giorno 14 della velocita' di deambulazione valutata mediante il test T25FW.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Open-label Run-in 7 – 91 Days - Double-blind Treatment Discontinuation Day 1 - Double-blind Treatment Days 8 to 14
    - Run In in aperto (giorni 7-91) - Sospensione del Trattamento in Doppio Cieco Giorno 1 -Trattamento in Doppio Cieco Giorno 8 e 14
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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.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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    periodo estensione in aperto
    open label extension period
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    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
    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 months30
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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)
    Upon completion of the trial patients will receive the expected normal treatment for their condition
    Al termine dello studio i pazienti riceveranno i trattamenti normali previsti per le loro condizioni
    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 Decision2011-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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