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    Summary
    EudraCT Number:2009-012431-15
    Sponsor's Protocol Code Number:KNL:URO-2009/1
    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:2009-12-02
    Trial 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 number2009-012431-15
    A.3Full title of the trial
    Možnosti terapeutického ovlivnění neurogenního hyperaktivního detruzoru u pacientů po spinálním poranění a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevřená studie porovnávající efekt aplikace 300 U Botoxu® při podání do detruzoru močového měchýře a subslizničního podání.

    Therapeutic Use of Botulinum-A toxin in Neurogenic Detrusor Overactivity in Patient after Spinal Cord Injury and Multiple Sclerosis. A Prospective, Open Study with Comparison of Suburothelial and Intradetrusor Application of 300 U of Botox®.
    A.4.1Sponsor's protocol code numberKNL:URO-2009/1
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKrajská nemocnice Liberec, a.s.
    B.1.3.4CountryCzech Republic
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    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
    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, Westport, Ireland
    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 and solvent 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 8000049323
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    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 typeButulinum A toxin
    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
    Studie se zabývá léčbou hyperaktivního neurogeního detruzoru u pacientů, kteří trpí příznaky hyperaktivního močového měchýře jako důsledek spinálního poranění nebo roztroušené sklerózy. K léčbě se pužívá botulinumotoxin. Ve studii se porovnávaní dvě různé formy aplikace studjiního léku.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primární cíl je efektivita léčby botulinumotoxinem. Sledovaným kritériem je:
    • Počet epizod inkontinence a frekvencí mikce/katetrizace podle mikčního diáře, který pacienti vyplňují 5 dní před každou návštěvou. Rozhodujícím bude změna od screeningové návštěvy vůči návštěvě v 12. týdnu.

    E.2.2Secondary objectives of the trial
    Sekundární cíl je posouzení léčby na kvalitu života a sledování vybraných parametrů:
    • Vliv léčby na kvalitu života. Měřeno pomocí standardizovaných dotazníků Incontinence Quality of Life Instrument a OAB-PSTQ. Rozhodujícím bude změna od screeningové návštěvy vůči návštěvě v 12. týdnu.
    • Urodynamické parametry – maximální cystometrická kapacita (MCC), maximální detruzorový tlak během netlumené kontrakce (Pdet max), kapacita močového měchýře při první netlumené kontrakci, compliance detruzoru
    • změna vymočeného/katetrizovaného objemu moči
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    5. 3. Zařazující kritéria:
    • muž či žena ve věku 15 až 70 let
    • podepsali informovaný souhlas
    • neurogenní hyperaktivita detruzoru jako důsledek spinálního poranění nebo roztroušené sklerózy
    • detruzorovou hyperaktivita je prokázána urodynamickým vyšetřením
    • detruzorová hyperaktivita není dostatečně zvládána standardní léčbou anticholinergiky, nebo má tato léčba závažné nežádoucí účinky
    • neurologický stav pacienta je stabilní (u spinálního poranění minimální odstup 6 měsíců od úrazu)
    • pacient má inkontinenci moči jako důsledek neurogenní hyperaktivity detruzoru, počet epizod inkontinence je ≥ 5 týdně
    • pacient zvládá techniku čisté intermitentní katetrizace nebo je schopen jí zvládnout
    E.4Principal exclusion criteria
    5. 4. Vyřazující kritéria:
    • nádorová onemocnění močového měchýře a prostaty
    • intersticiální cystitida
    • cystolitiáza
    • předchozí léčba botulinumtoxinem v posledním roce
    • stavy po radikálních chirurgických operacích v malé pánvi v posledním roce
    • stavy po operacích, které mohou mít vliv na hyperaktivitu detruzoru (operace cystokély, rektokély, TVT, TOT, TURP) v posledním roce
    • proběhlá radiační léčba malé pánve
    • alergie na studijní medikaci nebo její součásti
    • pacienti s rizikem vzniku mystenia gravis, amyotrofické laterální sklerózy nebo Eaton-Lambert syndromu
    • těhotné nebo kojící ženy, ostatní ženy v plodném věku musí užívat spolehlivou antikoncepci
    E.5 End points
    E.5.1Primary end point(s)
    Hlavním cílem této studie je posoudit efektivitu léčby přípravkem Botox® při subslizničním podání nebo podání do svalu močového měchýře (detruzoru) u pacientů, kteří trpí příznaky hyperaktivního močového měchýře jako důsledek spinálního poranění nebo roztroušené sklerózy.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    vliv různých cest aplikace na kvalitu života
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 40
    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)
    Pacientům bude po skončení studie poskyována standardní urologická péče tj. anticholinergika, technika čisté intermintentní katetrizace. Po schválení preparátu Botox pro použití v urologii potom další léčba botulotoxinem.
    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 Decision2010-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-12
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