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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42752   clinical trials with a EudraCT protocol, of which   7042   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

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    Summary
    EudraCT Number:2005-004996-40
    Sponsor's Protocol Code Number:04/SUR/3070
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-01-13
    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 ConcernedUK - MHRA
    A.2EudraCT number2005-004996-40
    A.3Full title of the trial
    A Prospective, Single-Arm, Open-label Study to Investigate the Efficacy and Safety of Intravesical Injection of Botulinum Toxin Type-A (750 Units Dysport®) for the Management of Neurogenic Detrusor Overactivity.
    A.3.2Name or abbreviated title of the trial where available
    Botulinum Toxin for the Management of Neurogenic Detrusor Overactivity
    A.4.1Sponsor's protocol code number04/SUR/3070
    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 SponsorR and D Department, Cardiff and the Vale NHS Trust
    B.1.3.4CountryUnited Kingdom
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Dysport
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.2Product code N/A
    D.3.4Pharmaceutical form Powder for injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClostridium botulinum type A toxin - haemagglutinin complex
    D.3.10 Strength
    D.3.10.3Concentration number500 Units / Vial
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 typeToxin
    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
    Neurogenic detrusor overactivity
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10029279
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the change in the quality of life and symptomatology score (as assessed using the scoring in the King’s Health Questionnaire (KHQ)) 6 Weeks after treatment with Botulin Toxin type A in comparison with the baseline score.
    E.2.2Secondary objectives of the trial
    To assess the change in the quality of life and symptomatology score (as assessed using the scoring in the KHQ) following treatment with Botulinum toxin Type A at all other time points in comparison with the baseline score.
    To assess the change in urodynamic parameters (volume at first detrusor contraction, detrusor compliance, maximum cystometric bladder capacity and post-void residual volume (as measured by ultrasound of the bladder).
    To assess the change in patient satisfaction with treatment (as assessed using the numerical rating scale).
    To assess the change in past-24 hour continence check findings.
    To assess the changes in bladder diary parameters.
    To compare the anticholinergic medication requirement at each assessment time point in comparison to the baseline visit.
    To assess the safety of treatment with Botulinum toxin Type A .
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. The patient must give informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal medical care.
    2. The patient must be between 18 and 75 years of age inclusive.
    3. The patient must have a diagnosis of a neurological problem of >1 yr duration.
    4. The patient must have urodynamically proven detrusor overactivity or low compliant bladder.
    5. The patient must have urinary symptoms resistant to anticholinergic medication, or suffer unacceptable side effects from anticholinergic therapy.
    6. The patient must be fit for flexible cystoscopy under local anaesthetic.
    7. The patient must be willing and able to use clean intermittent self-catheterisation (CISC) if this becomes necessary except those patients who have an indwelling catheter.
    8. The patient must be competent to give informed consent.
    9. The patient must be able and willing to comply with the requirements of the protocol.
    E.4Principal exclusion criteria
    1. The patient is suffering from any severe concomitant medical illness, or has significantly reduced renal or hepatic function.
    2. The patient has concurrent other bladder pathology.
    3. The patient has coexisting myasthenia gravis.
    4. The patient has a persistent urinary infection or un-investigated haematuria (if patients are diagnosed with a urinary tract infection at screening, part 2 of the screening assessments will be postponed until the infection had resolved).
    5. The patient has a history of blood clotting disorders or is on warfarin.
    6. The patient has any other serious illness or medical condition that in the opinion of the investigator would jeopardise the efficacy or safety of this treatment or any of the study assessments.
    7. The patient has any contraindication to the use of Botulinum toxin (any serotype).
    8. The patient has a known allergy or hypersensitivity to clostridium botulinum neurotoxin complex or to any of the excipients.
    9. The patient is pregnant or lactating. Female patients of child-bearing potential (i.e. who are not surgically sterile or < 1 year post-last menstrual period) must have a negative pregnancy test on the day of injection.
    10. The patient is a female at risk of pregnancy during the study, not taking adequate precautions against pregnancy.
    11. The patient is currently treated with, or has been treated during the week prior to the study with medications that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics.
    12. The patient has received any investigational drug therapy within 30 days prior to the study, or is scheduled to receive such a drug during the study period.
    13. The patient has previously entered this study.
    E.5 End points
    E.5.1Primary end point(s)
    Change in quality of life and symptomatology score (as assessed using the scoring in the ten domains of the King’s health questionnaire (KHQ)) at Week 6 in comparison with the baseline score.
    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 Information not present in EudraCT
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other No
    E.8.1.7.1Other trial design description
    open labelled, single arm
    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.8.3 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 Information not present in EudraCT
    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
    The end of the trial is 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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-01-13. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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.3.3.6.1Details of subjects incapable of giving consent
    Women of child bearing potential will only be included in the trial only after signing an informed consent to take adequate measures for contraception against pregnancy for the duration of trial.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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 receive normal medical care for their condition after the study has been completed. It is not certain whether treatment with Botulinum toxin will be offered by the Trust in the future.
    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 Decision2006-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-08-21
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