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    The EU Clinical Trials Register currently displays   37236   clinical trials with a EudraCT protocol, of which   6125   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2010-019162-83
    Sponsor's Protocol Code Number:Y5252120148
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-19
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III, multicentre study assesssing the long term safety and and efficay of repeated treatments with Dysport in the treatment of arm spasticity in adult patients with hemiparesis.
    A.4.1Sponsor's protocol code numberY5252120148
    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.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.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 pointCT Applications
    B.5.3 Address:
    B.5.3.1Street AddressZI de Courtaboeuf. 5 avenue du Canada
    B.5.3.2Town/ cityLes Ulis
    B.5.3.3Post code91966
    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. name DYSPORT™ for Injection
    D. 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.3.9.1CAS number 93384-43-1
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
    D.3.9.4EV Substance CodeSUB13117MIG
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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. medicinal product typeToxin
    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
    E.1.1.1Medical condition in easily understood language
    Arm Spasticity
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10048970
    E.1.2Term Arm spasticity
    E.1.2System Organ Class 100000004852
    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.
    E.2.2Secondary objectives of the trial
    The secondary study objective is to assess the long term efficacy of repeated treatment with 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 will be eligible for this open label extension study.

    De novo subjects must satisfy all of the following inclusion criteria to be eligible for the study:
    (1) Provision of written informed consent prior to any study related procedures.
    (2) Subjects with hemiparesis and aged between 18 and 80 years, inclusive.
    (3) Subjects who had one clinically defined stroke episode, as defined by the World Health Organisation (WHO) criteria or who have had one brain trauma, or subjects who had a nonevolutive lesion diagnosed prior to the stroke and in the same hemisphere as shown by brain imaging (i.e. scan or MRI).
    (4) At least 6 months post-stroke or traumatic brain injury.
    (5) 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. Please note that for the purpose of this protocol, a naïve subject is defined as a subject who has never received any BTX in the affected upper limb.
    (6) Disability Assessment Scale (DAS) score ≥2 on the PTT.
    (7) Spasticity angle ≥10° in the primary targeted muscle group.
    (8) Modified Frenchay Scale (MFS) overall score (average of all task scores)
    between 1 and 8 (including limit values).
    (9) Subjects able to receive 1000 U in their upper limb at Treatment Cycle 1.
    E.4Principal exclusion criteria
    Subjects (both rollover and do novo) are to be excluded if any of the following
    • 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 to treat spasticity of the affected 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.
    • Subjects treated or likely to be treated with intrathecal baclofen during the course of the study

    De novo subjects are to be excluded if any of the following additional criteria apply:
    (1) Physiotherapy initiated less than 4 weeks before entry or expected to be
    initiated during the study.
    (2) Previous treatment with BTX of any type within 4 months prior to study entry
    for any condition.
    (3) Previous primary or secondary non response to any BTXs for the targeted

    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
    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.
    E.5.2Secondary end point(s)
    In all of the following endpoints, the baseline is defined as the baseline in the double blind study for rollover subjects, and
    baseline visit (Cycle 1, Day 1) of this open label study for de novo subjects.
    • 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 , 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, 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.
    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.
    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. 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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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 Information not present in EudraCT
    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
    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 days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 194
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 No
    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 Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F. 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.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 119
    F.4.2.2In the whole clinical trial 258
    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 Decision2012-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-09
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