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    Summary
    EudraCT Number:2010-019069-28
    Sponsor's Protocol Code Number:Y-52-52120-145
    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:2012-01-05
    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 number2010-019069-28
    A.3Full title of the trial
    A phase III, multicentre, prospective, double blind, randomised, placebo controlled study, assessing the efficacy and safety 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 fase III, multicentrico, prospettico, in doppio cieco, randomizzato, controllato contro placebo, per valutare l'efficacia e la sicurezza di iniezioni intramuscolo di Dysport nel trattamento della spasticita' dell'arto superiore in soggetti adulti affetti da emiparesi spastica secondaria a ictus o a 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, double blind, randomised, placebo controlled study, assessing the efficacy and safety 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 fase III, multicentrico, prospettico, in doppio cieco, randomizzato, controllato contro placebo, per valutare l'efficacia e la sicurezza di iniezioni intramuscolo di Dysport nel trattamento della spasticita' dell'arto superiore in soggetti adulti affetti da emiparesi spastica secondaria a ictus o a lesione cerebrale traumatica.
    A.4.1Sponsor's protocol code numberY-52-52120-145
    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
    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
    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 efficacy of Dysport compared to placebo in reducing upper limb muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury. The primary study objective will be assessed by comparing between treatment groups at Week 4 the change from baseline in muscle tone (using the Modified Ashworth Scale (MAS)) in the primary targeted muscle group
    L'obiettivo primario dello studio consiste nella valutazione dell'efficacia di Dysport rispetto al placebo nella riduzione del tono muscolare dell'arto superiore in soggetti emiparetici affetti da spasticità dell'arto superiore secondaria a ictus o a lesione cerebrale traumatica. L'obiettivo primario dello studio sarà valutato confrontando la variazione rispetto al basale alla settimana 4 del tono muscolare (mediante la scala MAS, Modified Ashworth Scale) del principale gruppo muscolare bersaglio tra i gruppi di trattamento
    E.2.2Secondary objectives of the trial
    The secondary study objectives include assessments of the efficacy of Dysport compared to placebo on: • The Physician’s Global Assessment (PGA) of treatment response. • The upper limb passive function using the Principal Target of Treatment (PTT) of the Disability Assessment Scale (DAS)
    Gli obiettivi secondari dello studio includono le valutazioni dell'efficacia di Dysport rispetto al placebo per:
    • la valutazione globale del medico (PGA) della risposta al trattamento;
    • la funzionalità passiva dell'arto superiore usando il target principale del trattamento (PTT) della scala di valutazione della disabilità (DAS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Provision of written informed consent prior to any study related procedures. • Between 18 and 80 years of age, inclusive. • Only one clinically defined stroke episode (as defined by the World Health Organization criteria) or one traumatic brain injury. • At least 6 months post-stroke or post traumatic brain injury. • Modified Ashworth Scale (MAS) score ≥2 in the primary targeted muscle group for toxin naïve subjects or MAS score ≥3 in the primary targeted muscle group for toxin non naïve subjects at least 4 months after the last BTX injection, of any serotype. • Disability Assessment Scale (DAS) score ≥2 on the PTT. • Spasticity angle (measured on the TS) >10° in the primary targeted muscle group. • Modified Frenchay Scale (MFS) overall score (average of all task scores) between 1 and 8 (including limit values).
    Per essere eleggibili allo studio, i soggetti dovranno soddisfare i seguenti criteri di inclusione:
    • Dovranno aver firmato il consenso informato scritto prima di qualsiasi procedura correlata allo studio.
    • Dovranno avere un'età compresa tra 18 e 80 anni.
    • Dovranno avere avuto un solo episodio di ictus definito clinicamente (come definito dai criteri dell'OMS) o di una sola lesione cerebrale traumatica.
    • Dovranno essere trascorsi almeno 6 mesi dall'ictus o dalla lesione cerebrale traumatica.
    • Dovranno avere un punteggio della scala MAS (Modified Ashworth Scale) ≥2 del principale gruppo di muscoli nel caso di soggetti naïve per la tossina o un punteggio della scala MAS ≥3 del principale gruppo di muscoli nel caso di soggetti non naïve per la tossina almeno 4 mesi dopo l'ultima iniezione di BTX di qualsiasi sierotipo.• Dovranno avere un punteggio DAS (Disability Assessment Scale) ≥2 per il PTT.
    • Dovranno avere un angolo di spasticità (misurato con la scala TS) &gt;10° nel principale gruppo di muscoli bersaglio.
    • Dovranno avere un punteggio totale (media di tutti i punteggi delle attività) secondo la scala MFS (Modified Frenchay Scale) compreso tra 1 e 8 (compresi i valori limite).
    E.4Principal exclusion criteria
    Major limitation in the passive ROM at the affected elbow, wrist and fingers, as defined by: o Maximum passive elbow extension <150° (0° corresponding to the minimal stretch of the elbow flexors, which corresponds to a fully flexed elbow position), o Maximum passive wrist extension <70° (0° corresponding to the minimal stretch of the wrist flexors, which corresponds to a fully flexed wrist position), o Maximum passive finger extension <70° (0° corresponding to the minimal stretch of the extrinsic finger flexors, which corresponds to a formed fist with the second phalanx parallel to the metacarpal). • Physiotherapy initiated less than 4 weeks before entry or expected to be initiated during the study. • Previous treatment with BTX of any type within 4 months prior to study entry for any condition. • Subjects likely to be treated with BTX of any type in the lower limb during the course of this double blind study. • Previous primary or secondary non response to any BTXs for the targeted condition. • 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 adverse events (AEs) related to 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 excipient 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 (i.e. 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 traumatic brain injury) 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
    • Limitazione maggiore nel ROM passivo del gomito, del polso e della dita interessate, come definito da:
    o estensione passiva massima del gomito &lt;150° (0° corrisponde alla distensione minima dei flessori del gomito, cioè alla posizione del gomito completamente flesso),
    o estensione passiva massima del polso &lt;70° (0° corrisponde alla distensione minima dei flessori del polso, cioè alla posizione del polso completamente flesso),
    o estensione passiva massima del dito &lt;70° (0° corrisponde alla distensione minima dei flessori estrinseci delle dita, cioè alla posizione del pugno formato con la seconda falange parallela al metacarpale),
    • Fisioterapia iniziata nei 4 mesi precedenti l'inizio dello studio o programmata durante lo studio.
    • Precedente trattamento con BTX di qualsiasi tipo nei 4 mesi precedenti l'entrata nello studio per qualsiasi condizione.
    • Probabile trattamento con BTX di qualsiasi tipo dell'arto inferiore durante questo studio in doppio cieco.
    • Pregressa non risposta primaria o secondaria a qualsiasi BTX per la condizione in analisi.
    • Intervento chirurgico pregresso ai muscoli e ai legamenti interessati, ai tendini, ai tronchi nervosi o alle ossa dell'arto superiore trattato.
    • Trattamento pregresso con fenolo e/o alcool dell'arto superiore trattato in qualsiasi momento prima dello studio.
    • Qualsiasi condizione medica (tra cui disfagia grave o malattia respiratoria) che, secondo l'opinione dello sperimentatore, può aumentare la probabilità di eventi indesiderati (AE) correlati al trattamento con BTX.
    • Insufficienza neurologica maggiore, diversa dalla paresi spastica (tra cui atassia propriocettiva maggiore o aprassia sul lato paretico) che potrebbe influire negativamente sulla prestazione funzionale del soggetto.
    • Nota patologia delle giunzioni neuromuscolari (come la sindrome miastenica di Lambert-Eaton o la miastenia gravis).
    • Incapacità di comprendere le procedure e le richieste del protocollo, che, secondo l'opinione dello sperimentatore, potrebbe influire negativamente sulla compliance al protocollo.
    • Sensibilità nota alla BTX o a qualsiasi eccipiente di Dysport.
    • Infezione al(i) sito(i) di iniezione.
    • Non volontà o incapacità di attenersi al protocollo.
    • Trattamento in corso o pianificato con qualsiasi farmaco che interferisce direttamente o indirettamente con la funzione neuromuscolare (cioè, le aminoglicosidi) nelle ultime quattro settimane che precedono il trattamento dello studio.
    • Donne in gravidanza o in premenopausa, che non intendono usare misure anticoncezionali durante lo studio.
    • Trattamento con un nuovo farmaco sperimentale nelle quattro settimane che precedono l'arruolamento nello studio o un trattamento programmato con tale farmaco durante lo studio.
    • Qualsiasi malattia sottostante (non associata all'ictus o alla lesione cerebrale traumatica) che potrebbe influire sulla funzionalità dell'arto superiore e/o sul tono muscolare e/o sulla spasticità.
    • Qualsiasi condizione medica (o risultato di laboratorio) che, secondo il giudizio dello sperimentatore, possa compromettere la compliance con gli obiettivi e/o le procedure di questo protocollo o precludere la somministrazione della BTX.
    E.5 End points
    E.5.1Primary end point(s)
    Modified Ashworth Scale (MAS) for rating muscle tone in the primary targeted muscle group.
    Variabile di efficacia primaria
    • Scala MAS (Modified Ashworth Scale) per la classificazione del tono muscolare del principale gruppo di muscoli bersaglio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks
    4 settimane
    E.5.2Secondary end point(s)
    • Mean PGA Score
    • Mean change from baseline in the PTT of the DAS
    • Valutazione globale del medico (PGA) della risposta al trattamento.
    • Target principale del trattamento (PTT) della scala DAS per la misurazione della funzionalità passiva dell'arto superiore.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Mean PGA Score at Week 4.
    • Mean change from baseline in the PTT of the DAS at Week 4.
    . PGA: 4 settimane
    . Target principale del trattamento (PTT) della scala DAS per la misurazione della funzionalità passiva dell'arto superiore: 4 settimane
    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 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 trial3
    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 months21
    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 months21
    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. 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)
    Subjects who have completed the Week 12, Week 16, Week 20 or Week 24 follow up visit will be offered entry into the open label extension study
    Ai soggetti che avranno completato lo studio alla settimana 12 o 16 o 20 o 24 verrà proposto di partecipare allo studio di estensione in aperto
    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 Decision2011-05-30
    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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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