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    Summary
    EudraCT Number:2010-023210-31
    Sponsor's Protocol Code Number:Y-52-52120-155
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-13
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2010-023210-31
    A.3Full title of the trial
    A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.
    A.4.1Sponsor's protocol code numberY-52-52120-155
    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 pointSandrine Louis
    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 95 38
    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 Yes
    D.2.1.1.1Trade name Dysport
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 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 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 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
    NEUROGENIC DETRUSOR OVERACTIVITY
    E.1.1.1Medical condition in easily understood language
    Bladder Overactivity due to neurologic pathology
    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 10012547
    E.1.2Term Detrusor hyperreflexia
    E.1.2System Organ Class 100000004857
    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 a single dose of Dysport (750 U) compared to placebo for the improvement in the daily incontinence episode frequency (IEF) for each administration mode (15 or 30 injection sites).
    E.2.2Secondary objectives of the trial
    The secondary study objective is to assess the change over time in urodynamic parameters (manocystometric measurements according to the 'Good Urodynamic Practice' of the ICS) quality of life, catheterisations and the response to treatment following treatment with a single dose of Dysport (750 U) compared to placebo for each administration mode (15 or 30 injection sites), as well as the pain induced by the injection procedure.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Written informed consent prior to any study related procedures.
    (2) Male or female subjects aged 18 to 70, inclusive.
    (3) Urinary incontinence as a result of NDO due to documented SCI or MS as defined by the ICS guidelines .
    (4) Inadequate response or refractory to anticholinergic medication used to treat neurogenic overactive bladder.
    (5) The dose and class of anticholinergic treatment, if any, must be fixed for the duration of the study and stable at randomisation visit.
    (6a) Have documented SCI or MS (both complete and incomplete SCIs and relevant MS with confirmed NDO as defined by ICS guidelines will be included in this study).
    (7) Have documented urinary tract exploration at screening. If not, lower urinary tract echography shall be conducted prior to baseline.
    (8) Have a minimum average of two incontinence episodes per day calculated as the average daily IEF over the 3 days preceding the baseline visit (three consecutive 24 hour periods).
    (9) Subject, family member or care giver is willing and able to perform CIC for the duration of the study.
    (10) Have an exclusive and well trained voiding mode by clean self catheterisation before baseline.
    (11) Be able to complete all study requirements including completing a daily voiding diary and to attend all scheduled study visits, in the opinion of the Investigator.
    (12a) Female subjects of child-bearing potential must have a negative pregnancy test result and be willing to use reliable contraceptive measures for the duration of the study (i.e. oral contraceptives and spermicide, when used in combination with condoms, etc as a ‘double barrier method').
    (13) Botulinum toxin naïve for intra-detrusor injections and have no previous treatment with BTX of any type, within 3 months prior to study entry for any other condition.
    E.4Principal exclusion criteria
    (1) Greater than 3 L diuresis per day based on the average over the 3 days preceding the baseline visit (three consecutive 24 hour periods).
    (2a) Previous or current diagnosis of bladder disease and urethral disease or surgery, or prostate cancer (prostate specific antigen of >10 ng/mL). Subjects with serum prostate specific antigen concentrations >4 ng/mL and <10 ng/mL must have prostate cancer excluded.
    (3) Clinical symptomatic urinary tract infection at screening visit without adapted antibiotherapy.
    (4) History of NDO due to an aetiology other than SCI or MS.
    (5) History of stress incontinence.
    (6) Significant baseline renal and/or urinary tract pathology (e.g. hydronephrosis, stones, renal mass) at screening.
    (7) History of unexplained haematuria.
    (8) Known history of interstitial cystitis, uninvestigated haematuria, mullerian duct cysts, and urethral obstruction due to stricture/valves/sclerosis of urethral tumour, radiation cystitis, genitor-urinary tuberculosis, or bladder calculi.
    (9) Current indwelling catheter, or removal of chronic catheter <1 month prior
    to randomisation visit.
    (10) Any medical condition that may increase their risk of exposure to BTX including diagnosed myasthenia gravis, Lambert-Eaton Syndrome, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function.
    (11) Any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, may confound the study results, or may significantly interfere with the subject's participation in the study.
    (12) History of allergy or intolerance to local anaesthetics (lidocaine, xylocaine etc).
    (13) History of chronic drug or alcohol abuse.
    (14) Previous treatment with any endovesical pharmacologic agent including detrusor BTX injection.
    (15) Have previously undergone urethral stent placement or sphincterotomy.
    (16) Use of medications with anti-platelet or anticoagulant effects (except Low
    Molecular Weight Heparin) within 10 days of randomisation. (Low Molecular Weight Heparin is standard of care after SCI until 2 to 3 months post injury; for post SCI subjects it will be stopped 24 hours before and for 48 hours after each bladder injection).
    (17) Use of medications that affect neuromuscular transmission, such as curarelike
    depolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics.
    (18) Concurrent therapy which, in the Investigator's opinion, would interfere
    with the evaluation of study medication safety or efficacy.
    (19) Receipt of any experimental drug or use of any experimental device within
    30 days prior to the screening visit.
    (20) Nursing or lactating female subjects.
    (21) Known hypersensitivity to botulinum toxin (BTX) or to any components in the study drug formulation (including cow’s milk protein).
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline in the averaged daily frequency of episodes of urinary incontinence (calculated as the average daily IEF over the 3 days preceding each visit).
    E.5.1.1Timepoint(s) of evaluation of this end point
    to Day 84
    E.5.2Secondary end point(s)
    - Urodynamic examination: manocystometric measurements.
    - Quality of Life assessment.
    - Pain prior to and after administration of study treatment.
    - Clean self catheterisations per day.
    - Physician's global assessment of the treatment response as
    compared with baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Urodynamic examination / Quality of Life assessment / Clean self catheterisations per day / Physician's global assessment : Day 14, Day 42 and Day 84

    - Pain: prior to and after the cystoscopic intra-detrusor
    injection of study treatment (at baseline)
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial4
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    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 years
    E.8.9.1In the Member State concerned months7
    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.1.1Number 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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 42
    F.4.2.2In the whole clinical trial 42
    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)
    Return to standard of care treatment following the investigator's recommendations.
    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 Decision2012-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-21
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