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    Summary
    EudraCT Number:2012-000957-30
    Sponsor's Protocol Code Number:191622-117
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-12
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2012-000957-30
    A.3Full title of the trial
    BOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple Sclerosis
    A.4.1Sponsor's protocol code number191622-117
    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 SponsorAllergan Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportAllergan Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Limited
    B.5.2Functional name of contact pointAllergan Ltd. EU Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address1st Floor Marlow International, The Parkway
    B.5.3.2Town/ cityMarlow, Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628494444
    B.5.5Fax number+441628494449
    B.5.6E-mailml-eu_reg_affairs@allergan.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 BOTOX®
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameBOTOX®
    D.3.2Product code 9060X
    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 INNBotulinum Toxin Type A
    D.3.9.2Current sponsor codeAGN 191622
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    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
    Urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS)
    E.1.1.1Medical condition in easily understood language
    Urinary incontinence resulting from multiple sclerosis (MS)
    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 PT
    E.1.2Classification code 10046543
    E.1.2Term Urinary incontinence
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the safety and efficacy of 100 U BOTOX compared to
    placebo injected into the detrusor for the treatment of urinary incontinence due to NDO resulting from MS, in patients who are not catheterizing at baseline, and whose symptoms have not been adequately managed with an anticholinergic therapy.
    E.2.2Secondary objectives of the trial
    NAP
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    As part of a post-licensing commitment to the Irish Medicines Board, approximately 40 patients will be enrolled into an injection paradigm subset in which patients will receive treatment administered as 20 injections of 0.5mL instead of 30 injections of 1mL. The objective is to evaluate this additional intradetrusor injection paradigm. The study design for these patients will be identical in all other respects; the only difference will be the injection paradigm.
    This sub-study is included within the main protocol and therefore there is no separate title, date or version.
    E.3Principal inclusion criteria
    1) patient has multiple sclerosis, determined by documented patient history
    - patient’s MS is clinically stable for ≥ 3 months prior to screening, in the investigator’s opinion
    - patient has an Expanded Disability Status Scale (EDSS) score of ≤ 6.5

    2) patient has NDO for a period of at least 3 months prior to screening, determined by documented patient history
    - the presence of an involuntary detrusor contraction (IDC) must also be demonstrated during the urodynamic assessment in the screening period or day 1 (prior to randomization)

    3) patient has not been adequately managed with one or more anticholinergics for their urinary incontinence, in the opinion of the investigator. Not adequately managed is defined as meeting one of the following:
    - an inadequate response after at least a 4-week period of anticholinergic therapy on an optimized dose(s), ie, the patient was still incontinent despite anticholinergic therapy
    - limiting side effects after at least a 2-week period of anticholinergic therapy on an optimized
    dose(s)

    4) for patients taking anticholinergic medication for their NDO at study entry, dose is stable and patient is willing to maintain the same dose during study participation

    5) for patients not taking anticholinergics for their NDO at study entry, anticholinergics must have been discontinued at least 7 days prior to any screening procedures and anticholinergic treatment must not be commenced during the study

    6) patient experiences ≥ 3 and ≤ 60 episodes of urinary incontinence, with no more than one incontinence-free day, as recorded in the 3-day bladder diary completed during the screening period
    E.4Principal exclusion criteria
    1) patient currently uses clean intermittent catheterization (CIC) (at any frequency), or indwelling catheter, to manage their urinary incontinence

    2) per investigator judgment, patient should be using CIC to empty their bladder even if currently not doing so

    3) patient is unable or unwilling to use CIC post-treatment, if required

    4) patient has had previous or current botulinum toxin therapy of any serotype for any urological condition

    5) patient has had previous or current botulinum toxin therapy of any serotype for any non-urological condition within 12 weeks of randomization/day 1

    6) patient has history or evidence of any pelvic or urological abnormalities including but not limited to the following:
    - elevated serum creatinine > 2 times the upper limit of normal
    - current or previous uninvestigated hematuria (patients with investigated hematuria may enter the study if urological/renal pathology has been ruled out to the satisfaction of the investigator)
    - interstitial cystitis in the opinion of the investigator
    - bladder stones and/or bladder stone surgery at the time of screening or within 6 months prior to screening
    - surgery or bladder disease other than detrusor overactivity that may impact bladder function with the exception of surgeries > 1 year from screening for stress incontinence, uterine prolapse, rectocele, or cystocele

    - urethral and/or bladder outlet obstruction, in the opinion of the investigator
    7) patient has 24-hour total volume of urine voided > 3000 mL, collected over 24 consecutive hours during the 3-day bladder diary collection period during screening

    8) patient has a post-void residual (PVR) urine volume of >150 mL at screening. Note: the PVR measurement can be repeated once; the patient is to be excluded if the repeated measure is above 150 mL



    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure is the number of episodes of urinary incontinence as recorded by the patient in the 3 day bladder diary completed in the week prior to each study visit.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 6 after treatment 1
    E.5.2Secondary end point(s)
    - Maximum Cystometric Capacity (MCC, mL) by urodynamics as determined by the independent central reviewer
    - maximum detrusor pressure during the first Involuntary Detrusor Contraction (IDC, PmaxIDC) (cm H2O) by urodynamics as determined by the independent central reviewer
    - I-QOL total summary score as completed by the patient
    E.5.2.1Timepoint(s) of evaluation of this end point
    Urodynamics: Week 6 after treatment 1
    I-QOL: Week 6, 12, 24 after treatment 1 if only one treatment; Week 6, 12, within the qualification period for treatment 2 and 6 weeks after treatment 2
    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 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 EEA21
    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
    Belgium
    Canada
    Czech Republic
    France
    Poland
    Portugal
    Russian Federation
    United Kingdom
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days16
    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: 175
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 184
    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)
    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 Decision2013-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-27
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