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    Summary
    EudraCT Number:2014-002592-29
    Sponsor's Protocol Code Number:MIR-2014
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-12-29
    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 number2014-002592-29
    A.3Full title of the trial
    A randomized, double blind, placebo controlled study to evaluate the efficacy and safety of mirabegron 50 mg versus placebo in patients with neurogenic detrusor overactivity

    Randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie hodnotící efektivitu a bezpečnost podávání mirabegronu 50mg u pacientů s neurogenní hyperaktivitou detruzoru
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Administration of Mirabegron 50mg in patients with neurogenic bladder
    Podávání Mirabegronu 50mg u pacientů s neurogenním měchýřem
    A.3.2Name or abbreviated title of the trial where available
    MIRAGE
    MIRAGE
    A.4.1Sponsor's protocol code numberMIR-2014
    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 SponsorFakultní nemocnice Ostrava
    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 supportASTELLAS
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity hospital Ostrava
    B.5.2Functional name of contact pointDepartment of Urology
    B.5.3 Address:
    B.5.3.1Street AddressTřída 17.listopadu 1790
    B.5.3.2Town/ cityOstrava
    B.5.3.3Post code70852
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420597375301
    B.5.5Fax number+420597375305
    B.5.6E-mailjan.krhut@fno.cz
    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 Betmiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 nameBetmiga
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmirabegron
    D.3.9.1CAS number 223673-61-8
    D.3.9.3Other descriptive nameMIRABEGRON
    D.3.9.4EV Substance CodeSUB32690
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Spinal cord injury
    Multiple sclerosis
    Transverzální mišní léze
    Roztroušená skleróza mozkomišní
    E.1.1.1Medical condition in easily understood language
    In the trial patients with spinal cord injury and multiple sclerosis will be investigated
    Do studie budou zařazení pacienti s transverzální mišní lézí nebo roztroušenou sklerózou mozkomišní
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    Exploration of the mirabegron 50mg efficacy compaired to placebo in patients with NDO
    • Hodnotit efektivitu mirabegronu 50 mg proti placebu u pacientů s NDO
    E.2.2Secondary objectives of the trial
    To assess the safety of the mirabegron 50mg compairing with the placebo in patients with NDO
    To assess the mirabegron 50mg effect against placebo on the quality of the life
    • Hodnotit bezpečnost mirabegronu 50 mg proti placebu u pacientů s NDO
    • Hodnotit vliv mirabegronu 50 mg proti placebo na kvalitu života pacientů s NDO
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with the proved neurogenic detrusor overactivity NDO with complete or incomplete spinal cord injury or multiple sclerosis
    Symptoms of NDO stable of at least 6 month
    Patient able and willing to take the study medication according to the protocol
    Patient able and willing to attend all examinations according to the protocol
    • Muži nebo ženy ve věku 18-65 let
    • Písemný informovaný souhlas
    • Pacient s prokázanou neurogenní hyperaktivitou detruzoru v důsledku
    míšní léze (úplné nebo neúplné ) nebo roztroušené sklerózy
    • Symptomy neurogenní hyperaktivity detruzoru jsou stabilní ≥ 6
    měsíců
    • Pacient je ochoten a schopen brát studijní medikaci podle protokolu
    • Pacient je ochoten a schopen absolvovat vyšetření podle protokolu
    E.4Principal exclusion criteria
    Patients with the NDO of other origin than studied
    Patients with symptomatic infection of urinary tract
    Patients with interstitial cystitis, stones
    Patients with bladder cancer or after radiation therapy in pelvis
    Patients with severe renal or hepatic impairement
    Patients with severe or nontreated hypertension

    • Pacient s neurogenní hyperaktivitou detruzoru v důsledku jiného
    onemocnění než míšní léze (úplné nebo neúplné ) nebo roztroušené
    sklerózy
    • Pacient se symptomatickou infekcí močových cest (asymptomatická
    bakteriurie není považována za vylučovací kritérium)
    • Pacienti s intersticiální cystitidou, kameny močového měchýře,
    pacienti po ozáření pánevních orgánů pro zhoubné onemocnění
    • Závažné poškození ledvinných nebo jaterních funkcí v anamnéze
    • Pacienti s těžkou a neléčénou hypertenzí
    E.5 End points
    E.5.1Primary end point(s)
    Change of maximal cystometric capacity
    • Změna maximální cystometrické kapacity
    E.5.1.1Timepoint(s) of evaluation of this end point
    V3 visit compaired to the baseline investigation
    Visita V3 ve srovnání se vstupním vyšetřením
    E.5.2Secondary end point(s)
    Change in the volume of the nonvoiding contraction
    Change of the maximal detrusor pressure
    Change of the detrusor compliance
    Change in the 24hours pad-weight test
    Change in the i-QOL score
    Change in the PPBC score
    Change in the VAS TS score
    • Změna objemu při první netlumené kontrakci
    • Změna maximálního detruzorového tlaku v plnící fázi
    • Změny v complpiance detruzoru
    • Změny v hodnotě 24hod pad-testu
    • Změny ve skóre dotazníku I-QOL
    • Změny ve skóre dotazníku PPBC
    • Změny ve škále VAS TS
    E.5.2.1Timepoint(s) of evaluation of this end point
    V3 visit compaired to the baseline investigation
    Visita V3 ve srovnání se vstupním vyšetřením
    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 concerned3
    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 No
    E.8.7Trial has a data monitoring committee Yes
    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 finished
    Ukončení poslední vizity posledního pacienta
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 92
    F.1.3Elderly (>=65 years) No
    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 state92
    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)
    Patients will be followed-up in the department of urology and treated in the standard way
    Pacienti bodou dále sledování v urologické ambulanci a léčeni standardním způsobem
    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 Decision2015-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-17
    P. End of Trial
    P.End of Trial StatusOngoing
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