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    Summary
    EudraCT Number:2015-000554-38
    Sponsor's Protocol Code Number:D-FR-52120-221
    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:2015-05-06
    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 number2015-000554-38
    A.3Full title of the trial
    A Phase III, Multicenter, Double Blind, Randomised, Placebo Controlled Study to Assess the Efficacy and the Safety of a Single Cycle of Dysport Solution in the Treatment of Upper Limb Spasticity in Adult Subjects with Spastic Hemiparesis due to Stroke
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III, placebo controlled clinical trial to assess efficacy and safety of one dose of Dysport solution in the treatment of upper limb spasticity in adults after stroke
    A.4.1Sponsor's protocol code numberD-FR-52120-221
    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 pointGlobal Drug Development
    B.5.3 Address:
    B.5.3.1Street AddressZ.I. de Courtaboeuf, 5 Avenue du Canada
    B.5.3.2Town/ cityLes Ulis
    B.5.3.3Post code91940 CEDEX
    B.5.3.4CountryFrance
    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 No
    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.3.1Product nameDysport Solution
    D.3.2Product code BTX-A-HAC NG
    D.3.4Pharmaceutical form 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 INNCLOSTRIDIUM BOTULINUM TOXIN TYPE A
    D.3.9.1CAS number 93384-43-1
    D.3.9.2Current sponsor codeBTX-A-HAC
    D.3.9.3Other descriptive nameBOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX
    D.3.9.4EV Substance CodeSUB77183
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    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 typeBotulinum Toxin Type 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 placeboSolution 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
    upper limb spastic hemiparesis due to stroke
    E.1.1.1Medical condition in easily understood language
    upper limb spastic hemiparesis due to stroke
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10058978
    E.1.2Term Spastic hemiparesis
    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
    To assess the efficacy of Dysport Solution 1000 U compared to placebo in reducing the upper limb muscle tone (using the Modified Ashworth Scale (MAS)) in adult subjects with upper limb spastic hemiparesis due to stroke after one treatment cycle.
    E.2.2Secondary objectives of the trial
    The secondary study objective is the assessment of efficacy after one treatment cycle of Dysport Solution 1000 U compared to placebo on:
    •The Physician’s Global Assessment (PGA) of treatment response.
    •The spasticity using the Tardieu Scale (TS)
    •The active range of motion (ROM) against the upper limb muscles
    •The passive/perceived function using the Disability Assessment Scale (DAS)
    •A subject assessment of treatment response using a Visual Analog Scale (VAS)
    •The active upper limb function using the Box and Block test (BBT)
    The safety of Dysport Solution will also be assessed.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Provision of written informed consent prior to any study related procedures.
    2.Male or female subjects between 18 and 80 years of age, inclusive.
    3.Subjects with spastic hemiparesis, who had only one clinically defined stroke episode.
    4.Subjects who are at least 6 months post-stroke.
    5.Subjects who have a MAS score ≥2 in the primary targeted muscle group (PTMG) for toxin-naive subjects (never received any Botulinum toxin [BTX] in the affected upper limb) or ≥3 in the PTMG for toxin non-naive subjects.
    6.Spasticity angle (X of the Tardieu scale) ≥10° in the PTMG
    7.Female subjects of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 90 days after participation in the study. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device, or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
    8.Subjects must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period and willing to return to the clinic for the follow-up evaluation as specified in the protocol.
    E.4Principal exclusion criteria
    1.Major limitation in the passive ROM (XV1 of the Tardieu scale) at the affected elbow, wrist, and fingers, as defined by:
    •Maximum passive elbow extension <150° (0° corresponding to the minimal stretch of the elbow flexors, which corresponds to a fully flexed elbow position)
    •Maximum passive wrist extension <70° (0° corresponding to the minimal stretch of the wrist flexors, which corresponds to a fully flexed wrist position)
    •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)
    2.Subjects treated with BTX of any type within four months prior to study entry for any condition.
    3.Subjects who have experienced remote spread of effect of previous treatment with BTX (including generalized muscle weakness).
    4.Subjects likely to be treated with BTX of any type during the course of this study.
    5.Previous primary or secondary non-response to any BTXs for the targeted condition.
    6.Previous surgery to treat spasticity of the affected upper limb.
    7.Previous treatment with phenol and/or alcohol in the affected upper limb at any time before the study.
    8.Subjects treated or likely to be treated with intrathecal baclofen during the course of the study or during the 4 weeks before study entry.
    9.Physiotherapy initiated less than 4 weeks before entry or expected to be initiated during the study in the affected upper limb.
    10.Any medical condition (including severe dysphagia or airway disease) that may increase, in the opinion of the Investigator, the likelihood of Adverse Events related to BTX treatment.
    11.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.
    12.Known disease of the neuromuscular junction (such as Lambert Eaton myasthenic syndrome or myasthenia gravis).
    13.Known sensitivity to BTX or any component of Dysport Solution.
    14.Infection at the injection site(s).
    15.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.
    16.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.
    17.Any underlying disease (not associated with the stroke) likely to affect upper limb function and/or muscle tone and/or spasticity.
    18.Is pregnant or lactating. A pregnancy test will be performed at the start of the study for all female subjects of childbearing potential (i.e. not surgically sterile or 2 years postmenopausal).
    19.Has a history of, or known current, problems with substance or alcohol abuse.
    20.Has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
    21.Has any other medical condition(s) that, in the opinion of the investigator, might jeopardise the subject’s safety.
    E.5 End points
    E.5.1Primary end point(s)
    •Modified Ashworth Scale (MAS) raw score in the PTMG which can be elbow flexors, wrist flexors or extrinsic finger flexors
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4
    E.5.2Secondary end point(s)
    •Change from baseline in the MAS score in the PTMG
    •Number of subjects with a reduction of at least 1 grade on MAS score in PTMG.
    •Number of subjects with a reduction of at least 2 grades on MAS score in PTMG.
    •Change from baseline in the MAS score in shoulder extensors, elbow flexors, wrist flexors, and extrinsic finger flexors.
    •PGA score of treatment response.
    •Number of subjects reaching at least the grade +1 on the PGA.
    •Change from baseline in the TS parameters in the shoulder extensors, elbow flexors, wrist flexors, and extrinsic finger flexors.
    •Change from baseline in the active ROM in the shoulder extensors, elbow flexors, wrist flexors, and extrinsic finger flexors.
    •Number of subjects with a decrease from baseline of at least one grade in each of the 4 domains of the DAS scale.
    •Subject assessment of treatment response (VAS).
    •Change from baseline in performance of the BBT.
    Safety:
    •Adverse events throughout the study after signature of the Informed Consent form.
    •Vital signs (sitting systolic and diastolic blood pressure and heart rate)

    The safety endpoints are:
    •Adverse events throughout the study, after the signature of the Informed Consent form.
    •Vital signs (sitting systolic and diastolic blood pressure (BP) and heart rate (HR))
    E.5.2.1Timepoint(s) of evaluation of this end point
    The study visits considered for the analyses of efficacy endpoints will be baseline, Week 4, Week 12 (end of study) or early withdrawal.
    Vital signs at each study visit.
    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 trial2
    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 EEA13
    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
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 43
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 93
    F.4.2.2In the whole clinical trial 93
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-24
    P. End of Trial
    P.End of Trial StatusCompleted
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