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    Summary
    EudraCT Number:2009-017723-26
    Sponsor's Protocol Code Number:Y5552120142
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-28
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-017723-26
    A.3Full title of the trial
    A phase III, prospective, multicentre, open label, extension study, to assess the long term safety and efficacy of repeated treatment of Dysport® intramuscular injection in the treatment of lower 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 leg
    spasticity in adult patients with hemiparesis.
    A.4.1Sponsor's protocol code numberY5552120142
    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 Pharma SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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.3.10 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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
    Leg Spasticity
    E.1.1.1Medical condition in easily understood language
    Leg 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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10024132
    E.1.2Term Leg spasticity
    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 lower 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 the assessment of the long term efficacy including:
    • Muscle tone in the gastrocnemius-soleus complex (GSC) (knee extended),
    • Muscle tone in the soleus muscle (knee flexed),
    • Physician’s Global Assessment (PGA) of treatment response,
    • Maximal and comfortable barefoot walking speeds,
    • Maximal and comfortable walking speeds with shoes,
    • Spasticity in the GSC (knee extended),
    • Spasticity in the soleus muscle (knee flexed),
    • Step length and cadence under different conditions,
    • Range of active ankle dorsiflexion,
    • Lower limb pain,
    • Quality of life (QoL),
    • Use of walking aids.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who have completed the double blind study (Study 140), up to the Week 12, Week 16, Week 20 or Week 24 follow up visit, and who do not have any major protocol deviation and/or any ongoing AEs (either of which, in the opinion of the Investigator, would pose an unacceptable risk to the subjects were they to continue receiving treatment) will be eligible for the study. Additionally, an informed consent for this open label extension study will be signed.
    E.4Principal exclusion criteria
    • Major limitation in the passive range of motion at the affected hip,
    knee or ankle, as defined by:
    ∘ maximum passive hip flexion (knee flexed) < 30º,
    ∘ maximum passive knee flexion (hip flexed) < 70º,
    ∘ maximum passive ankle dorsiflexion (knee flexed) < 10º,
    ∘ maximum passive knee extension < 160º.
    • Previous surgery to treat spasticity on the affected muscles and
    ligaments, tendons or nerve trunks of the treated lower limb.
    • Previous treatment with phenol and/or alcohol in the treated lower
    limb at any time before the study.
    • Cognitive impairment altering the capacity to comply with the trial
    according to Investigator's judgement.
    • Severe neurological impairment (not associated with the stroke or
    brain trauma) due to an underlying neuromuscular disease or any other
    underlying disease or condition affecting gait (for example, Multiple
    Sclerosis).
    • Known disease of the neuromuscular junction (such as Lambert Eaton
    myasthenic syndrome or myasthenia gravis).
    • Unwillingness or inability to comply with the protocol.
    • Major hypoaesthesia or ataxia on the paretic side.
    • Known sensitivity to Botulinum toxin (BTX) or any Dysport excipients.
    • Infection at the injection site(s).
    • Current or planned treatment with any drug that interferes either
    directly or indirectly with neuromuscular function (for example,
    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 within 4 weeks prior to
    enrolment into the study or scheduled treatment with such a drug during
    the study period.
    • Any medical condition (or laboratory finding), that 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.
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints:
    • Adverse events.
    • Vital signs (systolic and diastolic BP and HR) at Day 1 of Treatment Cycle 1 and at each study visit.
    • Clinical laboratory parameters at Day 1 of Treatment Cycle 1, Week 4 of each Treatment Cycle and at the end of study or early withdrawal (haematology and clinical chemistry).
    • 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. The antibodies will be measured in serum samples, initially by screening radioimmunoprecipitation assay (RIPA). If RIPA is positive, the result will be confirmed by a competitive RIPA confirmatory assay. Samples positive for the presence of binding antibodies in both the screening and confirmatory RIPAs, will be analysed for the presence of neutralising antibodies using the mouse protection assay (MPA).
    • A 12 lead ECG performed at Day 1 of Treatment Cycle 1, Week 4 of each Treatment Cycle and at the end of study or early withdrawal.

    Efficacy endpoints:
    In all of the following endpoints, the baseline is defined as the baseline in the double blind study.
    • Mean change from baseline in the muscle tone (MAS) measured in the GSC (knee extended).
    • Mean change from baseline in the muscle tone (MAS) measured in the soleus muscle (knee flexed).
    • Proportion of subjects with at least one grade reduction in the muscle tone (MAS) measured in the GSC (knee extended).
    • Proportion of subjects with at least one grade reduction in the muscle tone (MAS) measured in the soleus muscle (knee flexed).
    • Mean PGA score.
    • Mean change from baseline in the 10 metre comfortable WST with shoes and without walking aids: walking speed, step length and cadence.
    • Mean change from baseline in the 10 metre maximal WST with shoes and without walking aids: walking speed, step length and cadence.
    • Mean change from baseline in the 10 metre comfortable WST barefoot and without walking aids: walking speed, step length and cadence.
    • Mean change from baseline in the 10 metre maximal WST barefoot and without walking aids: walking speed, step length and cadence.
    • Mean change from baseline in spasticity (TS) measured in the GSC with the knee extended (angle of catch (Xv3), spasticity angle (X) and spasticity grade (Y)).
    • Mean change from baseline in spasticity (TS) measured in the soleus muscle with the knee flexed (angle of catch (Xv3), spasticity angle (X) and spasticity grade (Y)).
    • Mean change from baseline in the range of active ankle dorsiflexion, both with the knee flexed (90°) and with the knee extended.
    • Mean change from baseline in lower limb pain.
    • Change from baseline in the use of walking aids/orthoses.
    • Mean change from baseline in QoL scales.
    • Mean change from baseline in muscle tone (MAS) measured in each of the injected upper limb muscle groups.
    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 No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    LPLV
    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 months10
    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 months10
    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.1.1.1In 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: 191
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 157
    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 Yes
    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.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 146
    F.4.2.2In the whole clinical trial 348
    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 Decision2011-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-28
    P. End of Trial
    P.End of Trial StatusCompleted
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