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    Summary
    EudraCT Number:2010-019162-83
    Sponsor's Protocol Code Number:Y-52-52120-148
    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:2012-01-10
    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 number2010-019162-83
    A.3Full title of the trial
    A phase III, multicentre, prospective, open label extension study to assess the long term safety and efficacy of repeated treatment of Dysport intramuscular injections used for the treatment of upper limb spasticity in adult subjects with spastic hemiparesis due to stroke or traumatic brain injury
    Studio di estensione di fase III, multicentrico e prospettico in aperto volto a valutare la sicurezza e l`™efficacia a lungo termine del trattamento ripetuto con iniezioni intramuscolari di Dysport per il trattamento della spasticita' degli arti superiori, in soggetti adulti affetti da emiparesi spastica causata da ictus o lesione cerebrale traumatica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III, multicentre, prospective, open label extension study to assess the long term safety and efficacy of repeated treatment of Dysport intramuscular injections used for the treatment of upper limb spasticity in adult subjects with spastic hemiparesis due to stroke or traumatic brain injury
    Studio di estensione di fase III, multicentrico e prospettico in aperto volto a valutare la sicurezza e l’efficacia a lungo termine del trattamento ripetuto con iniezioni intramuscolari di Dysport per il trattamento della spasticita' degli arti superiori, in soggetti adulti affetti da emiparesi spastica causata da ictus o lesione cerebrale traumatica
    A.4.1Sponsor's protocol code numberY-52-52120-148
    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 PHARMA SAS
    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 pointCo-ordinating and Monitoring office
    B.5.3 Address:
    B.5.3.1Street Address5 Avenue du Canada
    B.5.3.2Town/ cityLes Ulis-Cedex
    B.5.3.3Post code91940
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 (0) 160 92 94 38
    B.5.5Fax number+33 (0) 160 92 94 61
    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 for Injection
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Biopharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.10 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
    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
    Arm Spasticity
    Spasticità arti superiori
    E.1.1.1Medical condition in easily understood language
    Arm Spasticity
    Spasticità arti superiori
    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 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary study objective is to assess the long term safety of Dysport in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles
    Valutare la sicurezza a lungo termine di cicli di trattamento ripetuti con Dysport nei soggetti emiparetici con spasticità degli arti superiori causata da ictus o lesione cerebrale traumatica.
    E.2.2Secondary objectives of the trial
    The secondary study objective is to assess the long term efficacy of repeated treatment with Dysport
    Valutare l’efficacia a lungo termine di un trattamento ripetuto con Dysport
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who have completed the double blind study (Study 145) up to the Week 12, Week 16, Week 20 or Week 24 follow up visit
    - aver completato lo studio in doppio cieco (Studio 145) fino alla visita di follow-up alla settimana 12 o 16 o 20 o 24
    E.4Principal exclusion criteria
    • Major limitation in the passive ROM at the affected wrist, fingers and elbow, as defined by: o Maximum passive elbow extension <150º (0º corresponding to the minimal stretch of the elbow flexors, which corresponds to a fully flexed elbow position). o Maximum passive wrist extension <70º (0º corresponding to the minimal stretch of the wrist flexors, which corresponds to a fully flexed wrist position). o Maximum passive finger extension <70º (0º corresponding to the minimal stretch of the extrinsic finger flexors, which corresponds to a formed fist with the second phalanx parallel to the metacarpal). • Previous surgery on the affected muscles and ligaments, tendons, nerve trunks or bones of the treated upper limb. • Previous treatment with phenol and/or alcohol in the treated upper limb anytime before the study. • Any medical condition (including severe dysphagia or airway disease) that may increase, in the opinion of the Investigator, the likelihood of AEs related to botulinum toxin (BTX) treatment. • Major neurological impairment other than spastic paresis (including major proprioceptive ataxia or apraxia on the paretic side) that could negatively impact on the functional performance of the subject. • Known disease of the neuromuscular junction (such as Lambert Eaton myasthenic syndrome or myasthenia gravis). • Inability to understand protocol procedures and requirements which, in the opinion of the Investigator, could negatively impact on protocol compliance. • Known sensitivity to BTX or any excipients of Dysport. • Infection at the injection site(s). • Unwillingness or inability to comply with the protocol. • Current or planned treatment with any drug that interferes either directly or indirectly with neuromuscular function (e.g. aminoglycosides) within the last 4 weeks prior to study treatment. • Pregnant women, or premenopausal women not willing to use contraceptive measures throughout the duration of the study. • Treatment with a new investigational drug in the 4 weeks prior to enrolment into the study or scheduled to receive such a drug during the study period. • Any underlying disease (not associated with the stroke or brain trauma) likely to affect upper limb function and/or muscle tone and/or spasticity. • Any medical condition (or laboratory finding), which in the opinion of the Investigator may compromise compliance with the objectives and/or procedures of this protocol or preclude the administration of BTX.
    • Importante limitazione dell’escursione di movimento passivo del polso, delle dita e del gomito interessati, secondo quanto definito di seguito:
    o massima estensione passiva del gomito &lt;150º (0º corrisponde all’allungamento minimo dei flessori del gomito, che corrisponde alla posizione del gomito completamente flesso);
    o massima estensione passiva del polso &lt;70º (0º corrisponde all’allungamento minimo dei flessori del polso, che corrisponde alla posizione del polso completamente flesso);
    o massima estensione passiva delle dita &lt;70º (0º corrisponde all’allungamento minimo dei flessori estrinseci delle dita, che corrisponde al pugno formato con la seconda falange parallela al metacarpo).
    • precedente intervento chirurgico sui muscoli e i legamenti, i tendini, i tronchi nervosi o le ossa interessati dell’arto superiore trattato;
    • precedente trattamento con fenolo e/o alcool nell’arto superiore trattato in qualsiasi momento prima dello studio;
    • qualsiasi condizione medica (inclusa una forma grave di disfagia o insufficienza respiratoria grave) che, a giudizio dello Sperimentatore, potrebbe aumentare la probabilità di eventi avversi associati al trattamento con tossina botulinica (BTX);
    • danno neurologico importante diverso dalla paresi spastica (inclusa una forma importante di atassia o aprassia propriocettiva sul lato paretico) in grado di influire negativamente sulla funzionalità del soggetto;
    • malattia nota della giunzione neuromuscolare (ad es., sindrome miastenica di Lambert-Eaton o miastenia grave);
    • incapacità di capire le procedure e i requisiti del protocollo che, a giudizio dello Sperimentatore, potrebbe influire negativamente sull’rispetto dello stesso;
    • sensibilità nota alla BTX o a qualche eccipiente di Dysport;
    • infezione presso i punti di iniezione;
    • riluttanza o incapacità di aderire al protocollo;
    • trattamento in corso o programmato con un farmaco in grado di interferire direttamente o indirettamente con la funzione neuromuscolare (ad es., aminoglicosidi) nelle ultime 4 settimane precedenti il trattamento dello studio;
    • donne in gravidanza o donne in età fertile non disposte a usare metodi contraccettivi per l’intera durata dello studio;
    • trattamento con un nuovo farmaco sperimentale nelle 4 settimane precedenti l’arruolamento nello studio o in programma durante il periodo dello studio;
    • patologia sottostante (non associata a ictus o a lesione cerebrale) in grado di influire sulla funzionalità dell’arto e/o sul tono muscolare e/o sulla spasticità;
    • qualsiasi condizione medica (o risultato di test clinici di laboratorio) che, a giudizio dello sperimentatore, può compromettere il raggiungimento degli obiettivi e/o l'esecuzione delle procedure di questo protocollo o precludere la somministrazione della BTX.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints: •Adverse events (AEs) •Vital signs (systolic and diastolic BP and HR) •Clinical laboratory parameters (haematology and clinical chemistry) •Presence of BTX A Abs •A 12 lead ECG
    Valutazioni di sicurezza
    - eventi avversi
    - segni vitali (frequenza cardiaca e pressione arteriosa)
    - test clinici di laboratorio (ematologia e chimica clinica)
    - presenza di anticorpi anti BTX-A (BTX-A-Abs)
    - ECG a 12 lead
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Adverse events (AEs) at each study visit. • Vital signs (systolic and diastolic BP and HR) at Day 1 of Treatment Cycle 1 and at each study visit. • Clinical laboratory parameters (haematology and clinical chemistry) at Day 1 of Treatment Cycle 1, Week 4 of each treatment cycle and at the end of study or early withdrawal. • Presence of BTX A Abs at Day 1 of Treatment Cycle 1, Week 4 of each treatment cycle and at the end of study or early withdrawal. • A 12 lead ECG at Day 1 of Treatment Cycle 1, Week 4 of each treatment cycle and at the end of study or early withdrawal.
    - eventi avversi: a tutte le visite;
    - segni vitali (frequenza cardiaca e pressione arteriosa): giorno 1 di ogni ciclo di trattamento e ad ogni visita;
    - test clinici di laboratorio (ematologia e chimica clinica:giorno 1 e settimana 4 di ciascun ciclo di trattamento e prematura interruzione;
    - presenza di anticorpi anti BTX-A (BTX-A-Abs): giorno 1 e settimana 4 di ciascun ciclo di trattamento e interruzione anticipata/fine dello studio;
    - ECG a 12 lead: giorno 1 e settimana 4 del ciclo 1 di trattamento e interruzione anticipata/fine dello studio
    E.5.2Secondary end point(s)
    • Mean change from baseline in the MAS in the primary targeted muscle group. • Mean change from baseline in the MAS in the following muscle groups: shoulder extensors, elbow flexors and pronators, wrist flexors and extrinsic finger flexors in subjects injected in these muscle groups and having a baseline MAS score ≥2. • Proportion of subjects with at least one grade decrease from baseline on the MAS in the primary targeted muscle group. • Mean PGA score. • Mean change from baseline in the Principal Target of Treatment (PTT) of the DAS. • Mean change from baseline in the MFS overall score (i.e. mean score over the 10 tasks). • Proportion of subjects with a decrease from baseline of at least one grade in the PTT and in each domain of disability of the DAS for subjects having a baseline score ≥2 in the considered domain. • Mean change from baseline in the TS in the primary targeted muscle group (spasticity grade, angle of catch and spasticity angle). • Mean change from baseline in the TS in the shoulder extensors, elbow flexors and pronators, wrist flexors and extrinsic finger flexors in subjects injected in these muscle groups and with a baseline spasticity angle >10º (spasticity grade, angle of catch and spasticity angle). • Mean change from baseline in the active ROM against the primary targeted muscle group. • Mean change from baseline in the ease of applying splints. • Mean change from baseline in QoL measured on the Short Form (36) Health Survey and European QoL 5 Dimensions scales.
    In all of the following endpoints, the baseline is defined as the baseline in the double blind study.
    • Variazione media rispetto al basale nel punteggio MAS nel principale gruppo muscolare trattato.
    • Variazione media rispetto al basale nel punteggio MAS nei seguenti gruppi muscolari: estensori della spalla, flessori e pronatori del gomito, flessori del polso e flessori estrinseci delle dita nei soggetti che hanno ricevuto l’iniezione in questi muscoli e con un punteggio MAS al basale ≥2.
    • Proporzione di soggetti con una diminuzione di almeno un grado rispetto al basale sulla scala MAS nel principale gruppo muscolare trattato.
    • Punteggio PGA medio.
    • Variazione media rispetto al basale del Principal Target of Treatment (PTT) della scala DAS.
    • Variazione media rispetto al basale del punteggio MFS complessivo (ovvero punteggio medio su 10 attività).
    • Proporzione di soggetti con una diminuzione rispetto al basale di almeno un grado nel PTT e in ciascun dominio di invalidità della DAS per soggetti con un punteggio al basale ≥2 nel dominio considerato.
    • Variazione media rispetto al basale nel TS nel principale gruppo muscolare trattato (grado di spasticità, angolo di presa e angolo di spasticità).
    • Variazione media rispetto al basale nel TS negli estensori della spalla, nei flessori e nei pronatori del gomito, nei flessori del polso e nei flessori estrinseci delle dita nei soggetti che hanno ricevuto l’iniezione in questi gruppi muscolari e con un angolo di spasticità al basale >10º (grado di spasticità, angolo di presa e angolo di spasticità).
    • Variazione media rispetto al basale nell’escursione di movimento attivo in rapporto al principale gruppo muscolare trattato.
    • Variazione media rispetto al basale nella facilità di applicazione degli splint.
    • Variazione media rispetto al basale nella QoL misurata mediante i questionari Short Form (36) Health Survey e European QoL-5 Dimensions (EQ-5D).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The study visits considered for the analysis of the efficacy endpoints (with the exception of QoL) will be Week 4, Week 12 and potentially Week 16, Week 20 and Week 24 of each treatment cycle. The study visit considered for the analyses of the QoL will be the end of the study or early withdrawal.
    Le visite dello studio considerate per l’analisi degli endpoint di efficacia (ad eccezione di QoL) saranno quelle della Settimana 4, Settimana 12 ed eventualmente quelle della Settimana 16, Settimana 20 e Settimana 24 di ogni ciclo di trattamento. La visita dello studio considerata per le analisi della QoL sarà quella di fine studio o di interruzione anticipata.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 trial1
    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 EEA17
    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
    Russian Federation
    United States
    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 months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months24
    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: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 103
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects with a legally acceptable representative will be allowed into the study. The language in the ICF will be such that it is understood by the subject caregiver
    pazienti con un legale rappresentante. il linguaggio del foglio informativo è tale da essere compreso dalla persona che si prende cura del paziente.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 228
    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)
    not applicable
    non applicabile
    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 Decision2011-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-30
    P. End of Trial
    P.End of Trial StatusCompleted
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