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    Summary
    EudraCT Number:2014-004641-27
    Sponsor's Protocol Code Number:UZLeuven
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-04-21
    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 number2014-004641-27
    A.3Full title of the trial
    BOTOX in the treatment of urinary incontinence due to neurogenic detrusor overactivity in patients 3 months - 17 years
    BOTOX in de behandeling van neurogene blaasdysfunctie bij kinderen tussen 3 maanden en 17 jaar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with Botox in patients with urinary incontinence (accidental loss of urine) due to neurogenic detrusor overactivity (bladder problems resulting from disease or damage to the nervous system
    Botoxbehandeling bij patiënten met urine-incontinentie (accidenteelverlies) door neurogene overactiviteit van de detrusor (blaasproblemen ten gevolge van ziekte of schade aan het centraal zenuwstelsel)
    A.3.2Name or abbreviated title of the trial where available
    Botox treatment
    Botoxbehandeling
    A.4.1Sponsor's protocol code numberUZLeuven
    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 SponsorUZLeuven
    B.1.3.4CountryBelgium
    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 supportUZLeuven
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZLeuven
    B.5.2Functional name of contact pointUrology trial
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3216346930
    B.5.5Fax number3216348349
    B.5.6E-mailguy.bogaert@uzleuven.be
    D. IMP Identification
    D.IMP: 1
    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 Botox
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Intravesical solution/solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    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
    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
    Urinaire incontinentie door neurogene detrusor overactiviteit
    E.1.1.1Medical condition in easily understood language
    Accidental loss of urine due to bladder problems resulting from disease or damage to the nervous system
    Accidenteel urineverlies door blaasproblemen ten gevolge van ziekte of schade aan het zenuwstelsel
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10029279
    E.1.2Term Neurogenic bladder
    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
    Children who are still incontinent but have no shown detrusor contraction during urodynamic investigation
    Kinderen die nog incontinent zijn, maar geen aantoonbare detrusorcontractie hebben tijdens het urodynamisch onderzoek
    E.2.2Secondary objectives of the trial
    Not applicable
    Niet van toepassing
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Not applicable
    Niet van toepassing
    E.3Principal inclusion criteria
    - Male or female, ≥ 0 and ≤ 17 years of age at the moment of signing the informed consent
    - Patient with neurogenic bladder dysfunction shown during urodynamic investigation with or without overactive detrusor contraction
    - Neurogenic detrusor overactivity caused by;
    * spinal dysrafie, more specifically spina bifida (e.g. myelomeningocele, meningocele) and all forms of tethered cord
    * Acquired neurogenic detrusor overactivity due to spinal cord injury
    - Regular intermittent sondage to empty the bladder
    - more than 4 episodes of urine incontinence over two days in the miction diary
    - the neurogenic bladder dysfunction is not sufficiently controlled with anticholinergics only
    - Mannelijk of vrouwelijk, ≥ 0 jaar tot ≤ 17 jaar op moment van ondertekenen van geïnformeerde toestemming
    - Patiënt heeft neurogene blaasdysfunctie, bewezen tijdens urodynamisch onderzoek. Hierbij kan al dan niet een overactieve detrusorcontractie worden opgemerkt of niet
    - Neurogene detrusoractiviteit veroorzaakt door:
    * Spinale dysrafie, hetgeen spina bifida (bv. myelomeningocele, meningocele) en alle vormen van tethered cord
    * Verworven neurogene detrusoroveractiviteit door een ruggenmerglaesie
    - Patiënt moet regelmatig intermittente sondage gebruiken om de blaas te ledigen
    - Patiënt moet ≥ 4 episodes van urine-incontinentie hebben over twee dagen in het mictiedagboek
    - De neurogene blaasdysfunctie is onvoldoende onder controle met enkel anticholinergica
    E.4Principal exclusion criteria
    - occurence of uncontrolled systemic diseases
    - occurence of malignancies
    - spinal cord surgery during the past 6 months
    - additional pelvic or urologic abnormalities (open bladder neck, urethra stricture/urethra valve
    - predominance of stress incontinence
    - aanwezigheid van ongecontroleerde systeemziekten
    - aanwezigheid van maligniteiten
    - ruggenmergchirurgie in de afgelopen 6 maanden
    - bijkomende pelvische of urologische abnormaliteiten (open blaashals, urethrastrictuur/urethraklep
    - predominantie van stress incontinentie
    E.5 End points
    E.5.1Primary end point(s)
    - efficacy: The data of the miction diaries are studied during use of intradetrusor injections with Botox
    - Safety: To confirm the safety of Botox in children on the basis of medical history, clinical investigation and labo
    - efficiëntie: De gegevens van de mictiedagboeken worden bestudeerd gedurende gebruik van intradetrusorinjecties met Botox
    - veiligheid: De veiligheid van Botox bij kinderen confirmeren aan de hand van anamnese, klinisch onderzoek, labo
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Screening
    - Treatment
    - Visits: week 2, 6, 12, 24, 36 and 48
    - Calls: week 18, 30 and 42
    - Screening
    - Behandeling
    - Visites: week 2, 6, 12, 24, 36 en 48
    - telefonisch contact: week 18, 30 en 42
    E.5.2Secondary end point(s)
    Not applicable
    Niet van toepassing
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Niet van toepassing
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    LVLS
    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 days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 30
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patient population: inclusion possible as from the age of 3 months
    patiëntenpopulatie: inclusie mogelijk vanaf 3 maanden
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    None
    Geen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-21
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-06-08
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