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    Summary
    EudraCT Number:2010-023210-31
    Sponsor's Protocol Code Number:Y-52-52120-155
    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:2012-03-12
    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 number2010-023210-31
    A.3Full title of the trial
    A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS
    Studio clinico pilota multicentrico, a doppio cieco, a dose singola, a gruppi paralleli, controllato con placebo, di fase IIa per valutare l'efficacia e la sicurezza di una singola dose iniettata per via intradetrusoriale di 750 unita' di Dysport in soggetti affetti da iperattivita' detrusoriale neurogena conseguente a lesione del midollo spinale o a sclerosi multipla
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis
    Lo scopo di questo studio e' quello di valutare l'efficacia e la sicurezza delle iniezioni intradetrusoriali di Dysport confrontato a un placebo nei pazienti affetti da iperattivita' del detrusore di origine neurogena conseguente a lesione del midollo spinale o a sclerosi multipla
    A.4.1Sponsor's protocol code numberY-52-52120-155
    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 SponsorIPSEN INNOVATION
    B.1.3.4CountryFrance
    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 supportIPSEN Innovation
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIPSEN Innovation
    B.5.2Functional name of contact pointOperazioni Cliniche
    B.5.3 Address:
    B.5.3.1Street Address5 AVENUE DU CANADA
    B.5.3.2Town/ cityLES ULIS
    B.5.3.3Post code91940 cedex
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 (0)1 60 92 20 00
    B.5.5Fax number+33 (0)1 69 07 38 02
    B.5.6E-mailct-application@ipsen.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 DYSPORT*SC IM 2FL 500U
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN SpA
    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 Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBOTULINUM TOXIN TYPE A
    D.3.9.1CAS number 93384-43-1
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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 Yes
    D.3.11.13.1Other medicinal product typeTossina botulinica di tipo A
    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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    NEUROGENIC DETRUSOR OVERACTIVITY
    Overattività del detrusore di origine neurologica
    E.1.1.1Medical condition in easily understood language
    Bladder Overactivity due to neurologic pathology
    Iperattività della vescica dovuta ad una patologia neurologica
    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 10012547
    E.1.2Term Detrusor hyperreflexia
    E.1.2System Organ Class 10038359 - Renal and urinary 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 study objective is to assess the efficacy of a single dose of Dysport (750 U) compared to placebo for the improvement in the daily incontinence episode frequency (IEF) for each administration mode (15 or 30 injection sites).
    L'obiettivo primario dello studio è di valutare l'efficacia di una singola dose di Dysport (750 U) rispetto al placebo per il miglioramento della frequenza degli episodi di incontinenza (FEI) giornaliera per ciascuna modalità di somministrazione (15 o 30 siti di iniezione).
    E.2.2Secondary objectives of the trial
    The secondary study objective is to assess the change over time in urodynamic parameters (manocystometric measurements according to the 'Good Urodynamic Practice' of the ICS) quality of life, catheterisations and the response to treatment following treatment with a single dose of Dysport (750 U) compared to placebo for each administration mode (15 or 30 injection sites), as well as the pain induced by the injection procedure.
    L'obiettivo secondario dello studio è valutare le variazioni nel tempo dei parametri urodinamici (misurazioni cistomanometriche secondo la ''Good Urodynamic Practice'' della International Continence Society (ICS)), la qualità della vita, il cateterismo e la risposta al trattamento con una singola dose di Dysport (750 U) rispetto al placebo per ciascuna modalità di somministrazione (15 o 30 siti di iniezione), e il dolore conseguente alla procedura iniettiva.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Written informed consent prior to any study related procedures. (2) Male or female subjects aged 18 to 70, inclusive. (3) Urinary incontinence as a result of NDO due to documented SCI or MS as defined by the ICS guidelines . (4) Inadequate response or refractory to anticholinergic medication used to treat neurogenic overactive bladder. (5) The dose and class of anticholinergic treatment, if any, must be fixed for the duration of the study and stable at randomisation visit. (6) Have documented SCI or MS with urodynamic measurement abnormalities within 6 months (both complete and incomplete SCIs and relevant MS with confirmed NDO as defined by ICS guidelines will be included in this study). (7) Have documented urinary tract exploration at screening. If not, lower urinary tract echography shall be conducted prior to baseline. (8) Have a minimum average of two incontinence episodes per day calculated as the average daily IEF over the 3 days preceding the baseline visit (three consecutive 24 hour periods). (9) Subject, family member or care giver is willing and able to perform CIC for the duration of the study. (10) Have an exclusive and well trained voiding mode by clean self catheterisation before baseline. (11) Be able to complete all study requirements including completing a daily voiding diary and to attend all scheduled study visits, in the opinion of the Investigator. (12) Female subjects of child-bearing potential must have a negative pregnancy test result and be willing to use reliable contraceptive measures for the duration of the study. (13) Botulinum toxin naïve for intra detrusor injections and have no previous treatment with BTX of any type, within 3 months prior to study entry for any other condition.
    • Devono aver firmato il consenso informato per iscritto precedentemente a qualsiasi procedura collegata allo studio. • Devono essere soggetti di sesso maschile o femminile, tra i 18 e i 70 anni compresi. • Devono essere affetti da incontinenza urinaria da IDN dovuta a LMS o SM documentate così come definito dalle linee guida della ICS. • Devono aver avuto risposta inadeguata o essere refrattari ai farmaci anticolinergici utilizzati per trattare l'iperattività vescicale neurogena. • Il dosaggio e la classe del trattamento anticolinergico, se presente, devono essere fissi per la durata dello studio e stabili alla visita di randomizzazione. • La LMS o la SM devono essere documentate da parametri urodinamici anomali negli ultimi 6 mesi (possono essere inclusi nello studio pazienti affetti da LMS completa o incompleta e da SM importante con IDN confermata così come definita dalle linee guida della ICS). • Presenza di documentazione di esplorazione del tratto urinario allo screening. Se non presente, sarà eseguita un'ecografia del tratto urinario inferiore prima della visita basale. • Media minima di due episodi di incontinenza al giorno, calcolata sulla media giornaliera della FEI nei 3 giorni precedenti la baseline (3 periodi consecutivi di 24 ore). • Il soggetto o un membro della sua famiglia o la persona che se ne prende cura deve accettare ed essere in grado di eseguire il cateterismo intermittente pulito per la durata dello studio. • Modalità di evacuazione esclusiva e comprovata attraverso l'autocatete-rismo pulito prima della visita basale. • In grado secondo l'opinione dello sperimentatore di completare tutte le fasi dello studio, tra cui la compilazione del diario minzionale, e tutte le visite programmate per lo studio. • I soggetti di sesso femminile in età fertile devono risultare negativi al test di gravidanza e devono accettare di utilizzare mezzi contraccettivi affidabili per tutta la durata dello studio. • Non devono aver mai fatto iniezioni intradetrusoriali con tossina botulinica (BTX) e non devono aver mai eseguito trattamenti di nessun tipo con la BTX nei tre mesi precedenti lo studio.
    E.4Principal exclusion criteria
    (1) Greater than 3 L diuresis per day based on the average over the 3 days preceding the baseline visit (three consecutive 24 hour periods). (2) Previous or current requirement for/diagnosis of bladder or urethral surgery or disease/prostate cancer (prostate specific antigen of >10 ng/mL). Subjects with serum prostate specific antigen concentrations >4 ng/mL and <10 ng/mL must have prostate cancer excluded. (3) Clinical symptomatic urinary tract infection at screening visit without adapted antibiotherapy. (4) History of NDO due to an aetiology other than SCI or MS. (5) History of stress incontinence. (6) Significant baseline renal and/or urinary tract pathology (e.g. hydronephrosis, stones, renal mass) at screening. (7) History of unexplained haematuria. (8) Known history of interstitial cystitis, uninvestigated haematuria, mullerian duct cysts, and urethral obstruction due to stricture/valves/sclerosis of urethral tumour, radiation cystitis, genitorurinary tuberculosis, or bladder calculi. (9) Current indwelling catheter, or removal of chronic catheter <1 month prior to randomisation visit. (10) Any medical condition that may increase their risk of exposure to BTX including diagnosed myasthenia gravis, Lambert-Eaton Syndrome, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function. (11) Any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, may confound the study results, or may significantly interfere with the subject's participation in the study. (12) History of allergy or intolerance to local anaesthetics (lidocaine, xylocaine etc). (13) History of chronic drug or alcohol abuse. (14) Previous treatment with any endovesical pharmacologic agent including detrusor BTX injection. (15) Have previously undergone urethral stent placement or sphincterotomy. (16) Use of medications with anti platelet or anticoagulant effects (except Low Molecular Weight Heparin) within 10 days of randomisation. (Low Molecular Weight Heparin is standard of care after SCI until 2 to 3 months post injury; for post SCI subjects it will be stopped 24 hours before and for 48 hours after each bladder injection). (17) Use of medications that affect neuromuscular transmission, such as curarelike depolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics. (18) Concurrent therapy which, in the Investigator's opinion, would interfere with the evaluation of study medication safety or efficacy. (19) Receipt of any experimental drug or use of any experimental device within 30 days prior to the screening visit. (20) Nursing or lactating female subjects.
    • Hanno una diuresi speriore a 3 L al giorno, calcolata sulla media giornaliera dei 3 giorni precedenti la baseline (3 periodi consecutivi di 24 ore). • Hanno precedenti o attuali requisiti/diagnosi che richiedono intervento chirurgico vescicale o uretrale o malattia/cancro della prostata (antigeni specifici per la prostata &gt;10 ng/mL). I soggetti con concentrazioni sieriche dell’antigene prostatico specifico (PSA) &gt;4 ng/mL e &lt;10 ng/mL devono documentare l’esclusione di una diagnosi di carcinoma prostatico. • Presentano infezioni sintomatiche del tratto urinario alla visita di screening e non seguono specifica terapia antibiotica. • Presentano antecedenti episodi di IDN con eziologia diversa da LMS o SM. • Presentano antecedenti episodi di incontinenza da stress. • Presentano significative patologie renali o del tratto urinario (ad esempio idronefrosi, calcoli, massa renale) allo screening. • Presentano episodi antecedenti di ematuria senza spiegazione. • Presentano episodi conosciuti di cistite interstiziale, ematuria non esaminata, cisti del dotto mülleriano, o ostruzione uretrale dovuta alla presenza di stenosi, di valvole uretrali o alla sclerosi di un tumore uretrale, cistite da radioterapia, tubercolosi genito-urinaria o calcoli alla vescica. • Presentano cateterismo interno, o hanno subìto la rimozione di un cateterismo cronico meno di un mese prima della visita di randomizzazione. • Presentano patologie che possono aumentare il rischio legato alla tossina botulinica tra cui miastenia grave, sindrome di Lambert-Eaton, sclerosi laterale amiotrofica o altre malattie che potrebbero interferire con la funzione neuromuscolare. • Presentano una patologia o situazione che, secondo lo sperimentatore, potrebbe esporre il paziente ad un rischio significativo, alterare i risultati dello studio, o interferire significativamente con la partecipazione del soggetto allo studio. • Presentano episodi antecedenti di allergia o intolleranza agli anestetici locali (lidocaina, xilocaina, ecc.). • Presentano storia di abuso di droghe o di alcol. • Sono stati trattati in precedenza con agenti farmacologici endovescicali, tra cui iniezioni detrusoriali di BTX. • Sono stati sottoposti in precedenza a posizionamento di stent uretrale o sfinterotomia. • Hanno utilizzato farmaci anti aggreganti o anti coagulanti (eccetto l'eparina a basso peso molecolare) nei 10 giorni precedenti la randomizzazione. (L'eparina a basso peso molecolare è il trattamento di riferimento per la LMS nei 2/3 mesi successivi al trauma; per i soggetti con LMS questo trattamento sarà sospeso 24 ore prima e nelle 48 ore successive ad ogni iniezione vescicale). • Utilizzano farmaci aventi effetto sulla trasmissione neuromuscolare, come i farmaci pseudo-curarici depolarizzanti, gli anticolinesterasici, gli antibiotici della famiglia dei lincosamidi, delle polimixine e degli amminoglicosidici. • Sono trattati durante lo studio con terapie che, secondo lo sperimentatore, potrebbero interferire con la valutazione della tollerabilità o dell'efficacia del farmaco in studio. • Hanno ricevut o utilizzato qualsiasi altro farmaco o dispositivo sperimentale nei 30 giorni precedenti la visita di screening. • Soggetti di sesso femminile in periodo di allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline in the averaged daily frequency of episodes of urinary incontinence (calculated as the average daily IEF over the 3 days preceding each visit).
    Variazione media al giorno 84 rispetto alla visita basale della frequenza media degli episodi giornalieri di incontinenza urinaria (calcolata come FEI giornaliera media nei 3 giorni precedenti ogni visita).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 84
    Giorno 84
    E.5.2Secondary end point(s)
    - Urodynamic examination: manocystometric measurements. - Quality of Life assessment. - Pain prior to and after administration of study treatment. - Clean self catheterisations per day. - Physician's global assessment of the treatment response as compared with baseline.
    Esame urodinamico: misure manocistometriche. Valutazione della Qaulità di Vita Valutazione del dolore prima e dopo la somministrazione del trattamento. Numero di autocateterismi puliti al giorno Valutazione globale da parte del medico della risposta al trattamento rispetto alla baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Urodynamic examination / Quality of Life assessment / Clean self catheterisations per day / Physician's global assessment : Day 14, Day 42 and Day 84 - Pain: prior to and after the cystoscopic intra-detrusor injection of study treatment (at baseline)
    - Esami urodinamici/Qualità di Vita/Autocataterismi/Valutazione globale del medico: giorni 14, 42 e 84 - Dolore: prima e dopo l'iniezione intradetrusoriale del trattamento (alla visita basale)
    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 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 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 trial4
    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 EEA17
    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 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 years2
    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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 56
    F.4.2.2In the whole clinical trial 56
    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 patients suffering from neurogenic detrusor overactivity due to spinal cord injury or multiple sclerosis are treated as standard of care by anticholinergics depending on the personal tolerance to these medications of each patient. This treatment will be continued after the study following the investigator recommendations.
    I pazienti affetti da iperattività del detrusore di origine neurognea dovuta a lesione del midollo spinale o a slerosi multipla sono trattati secondo il trattamento di riferimento anticolinergico se ben tollerato individualmente. Questo trattamento sarà continuato dopo la fine dello studio su raccomandazione del medico.
    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 Decision2012-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-21
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