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    Summary
    EudraCT Number:2010-019907-43
    Sponsor's Protocol Code Number:Y-52-52120-134
    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:2011-01-31
    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 number2010-019907-43
    A.3Full title of the trial
    A phase III, randomised, double blind and open label phase, active and placebo controlled study comparing the short term efficacy of two formulations of clostridium botulinum type A toxin (Dysport and Dysport RU) to placebo, and assessing the short and long term efficacy and safety of Dysport RU following repeated treatments of subjects with cervical dystonia (CD).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This research study is to evaluate how well a new drug called Dysport RU works and how safe it is when it is used for the treatment of torticollis also called cervical dystonia. Dysport RU will be compared to an approved drug called Dysport.
    A.4.1Sponsor's protocol code numberY-52-52120-134
    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 point
    B.5.3 Address:
    B.5.3.1Street Address5 Avenue du Canada
    B.5.3.2Town/ cityLes Ulis
    B.5.3.3Post code91940
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)160 92 20 00
    B.5.5Fax number+33(0)169 07 38 02
    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 RU
    D.3.2Product code Dysport RU
    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.3.9.3Other 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) 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 typeToxin
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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
    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.3.1Product nameDysport
    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 INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A
    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) 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 typeToxin
    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
    Cervical Dystonia
    E.1.1.1Medical condition in easily understood language
    Torticollis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064124
    E.1.2Term Cervical dystonia
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 objectives will be assessed in terms of improvement of the subject’s CD at a pre-defined time point after treatment. The primary study objectives are to demonstrate the superiority of Dysport RU to placebo in terms of efficacy and to test the non-inferior efficacy of Dysport RU, when compared to Dysport, in CD subjects. In addition to testing for the primary study objectives, the superiority in terms of efficacy of Dysport versus placebo, will be assessed.
    E.2.2Secondary objectives of the trial
    The secondary study objectives are the assessment of the short and long term clinical safety and efficacy of Dysport RU following repeated treatment cycles.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects must fulfil the following inclusion criteria to be eligible for the study:
    (1) Provision of written informed consent prior to any study related procedures being carried out. In this study consent may be provided by the legal guardian or caregiver.
    (2) Male or female of legal age of consent for each participating country (i.e. ≥18 years).
    (3) Cervical Dystonia with at least 18 months duration since onset.
    (4) Previously untreated with BTX-A or -B or if previously treated with BTX-A or -B, a minimum of 14 weeks since the last injection must have elapsed.
    (5) Toronto Western Spasmodic Torticollis Rating Scale scores meeting the following criteria at baseline:
    - TWSTRS - Total score ≥30.
    - TWSTRS - Severity Sub-scale score ≥15.
    - TWSTRS - Disability Sub-scale score ≥3.
    - TWSTRS - Pain Sub-scale score ≥2.
    E.4Principal exclusion criteria
    Subjects will not be included in the study if any of the following are present/apply:
    (1) Known hypersensitivity to BTX or related compounds, or any component in the study drug formulations (including cow milk protein).
    (2) Pure anterocollis or pure retrocollis.
    (3) In apparent remission from CD.
    (4) Previous poor response as determined by standard practice at each site, (e.g. <20% improvement in TWSTRS total score from baseline to Week 4) to the last two BTX-A or -B treatments.
    (5) A known requirement for fewer than 80 or more than 300 BOTOX® units injected into the neck muscles, fewer than 4,000 U or more than 12,500 U of BTX-B, or <250 U or >1000 U of Dysport.
    (6) Subjects that are being treated with BTX-B due to lack of efficacy to BTX-A or have known neutralising antibodies to BTX-A.
    (7) A requirement for BTX injection(s) into site(s) of the body other than the neck and unable to avoid such treatment(s) for the duration of the study.
    (8) A known clinically significant underlying swallowing or respiratory abnormality which might be exacerbated by BTX treatment.
    (9) Have sub-clinical or clinical evidence of marked defective neuromuscular transmission (e.g. myasthenia gravis) or persistent clinically significant neuromuscular weakness or a condition that would interfere with TWSTRS scoring.
    (10) A total body weight less than 100 lbs (45.4 kg).
    (11) Previous phenol or alcohol injections into the neck muscles.
    (12) Previous myotomy or denervation surgery involving the neck or shoulder region.
    (13) Cervical contracture that limits passive range of motion.
    (14) Treatment with any drug that interferes either directly or indirectly with neuromuscular function (e.g. aminoglycoside antibiotics) within the last 30 days prior to study treatment.
    (15) A current or expected requirement for concomitant medication that may interfere with the evaluation of study treatment (e.g. narcotics).
    NOTE: muscle relaxants and benzodiazepines are permitted if the dosage has been stable for the 6 weeks prior to study treatment and is expected to remain at this stable dose until the Week 4 assessment. Every effort should be made to keep concomitant CD treatment constant throughout the study, however, changes in pain medication are acceptable if absolutely necessary according to clinical judgment.
    (16) Any medical condition or laboratory finding that might compromise compliance with the objectives and procedures of this protocol or preclude the administration of BTX-A, as judged by the Investigator (including infection at the site for injection).
    (17) In the opinion of the Investigator the subject is unable and/or unwilling to comply fully with the protocol and/or the study instructions.
    (18) Was treated with any other IMP or device within the last 30 days before study entry.
    (19) Is likely to require treatment during the study with drugs that are not permitted by the study protocol.
    (20) Pregnancy or lactation: women of child-bearing potential must have a negative pre-study urine pregnancy test and subjects, or their partner, must agree to use adequate contraception (hormonal or barrier method of birth
    control) prior to injection of study drug and for the duration of study participation. Non-childbearing potential is defined as post-menopausal for
    at least 1 year, surgical sterilisation at least three months before entering screening, or hysterectomy.
    (21) Previously treated in this study.
    (22) Has a history of, or known current problems with alcohol or drug abuse, which in the opinion of the Investigator could interfere with the subject’s participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in TWSTRS total score
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the post-treatment cycle 1 Week 4 office visit.
    E.5.2Secondary end point(s)
    •Change from baseline in the TWSTRS severity, disability and pain sub-scale scores.
    •Change from baseline in the subject’s VAS for pain from CD.
    •Change from baseline in the subject’s VAS for symptoms of CD.
    •Proportion of treatment responders
    •Change from treatment cycle baseline in TWSTRS total score
    •Safety: TEAEs , Vital signs, Clinical laboratory evaluations, Presence of BTX-A-Abs, ECG analysis
    E.5.2.1Timepoint(s) of evaluation of this end point
    The following efficacy endpoints will be assessed for treatment cycles 1 to 5 at week 4:
    - Change from treatment cycle baseline in TWSTRS total score, in the TWSTRS severity, disability and pain sub-scale scores, in the subject’s VAS for pain , in the subject’s VAS for symptoms
    - Proportion of treatment responders

    TEAEs: Day 1 and each post-baseline visit
    Vital signs: baseline and each post-baseline office visitafter
    Clinical laboratory evaluations and presence of BTX-A-Abs: baseline, at each cycle post-treatment Week 4 and end of the study/early withdrawal visit.
    ECG analysis: at cycle 1, 30 min post-treatment, at Week 4, at Week 12, at end of study.
    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 Yes
    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 Yes
    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 Yes
    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) Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Ukraine
    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
    Last patient Last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 215
    F.4.2.2In the whole clinical trial 350
    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)
    as per standard of care
    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 Decision2011-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-04
    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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