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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   43973   clinical trials with a EudraCT protocol, of which   7311   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).

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    EudraCT Number:2006-002143-83
    Sponsor's Protocol Code Number:191622-515
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-07-07
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2006-002143-83
    A.3Full title of the trial
    A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group
    Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of
    BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by
    Treatment with BOTOX® in Patients with Urinary Incontinence Due to
    Neurogenic Detrusor Overactivity
    A.4.1Sponsor's protocol code number191622-515
    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 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 support
    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. name BOTOX®
    D. of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 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.3.8INN - Proposed INNBotulinum toxin type A
    D.3.9.1CAS number 93384-43-1
    D.3.9.2Current sponsor codeAGN 191622
    D.3.9.3Other descriptive nameBotulinum toxin Type A (from Clostridium botulinum)
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 Allergan Unit
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Yes
    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 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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.0
    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 evaluate the safety and efficacy of each of 2 dosages of BOTOX® (200 U or 300 U)
    compared to placebo injected into the detrusor for the treatment of urinary incontinence
    caused by neurogenic detrusor overactivity in patients who have not been adequately
    managed with anticholinergic therapy.
    E.2.2Secondary objectives of the trial
    To evaluate the safety profile of BOTOX® when injected into the detrusor of patients with neurogenic detrusor overactivity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Patient is male or female, aged 18 to 80 years old.
    [2] Patient weighs ≥ 50 kg (110 lb).
    [3] Written informed consent has been obtained.
    [4] Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained.
    [5] Written Data Protection Consent (European sites only) has been obtained.
    [6] Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
    [7] Patient has urinary incontinence as a result of neurogenic detrusor overactivity for a period of at least 3 months prior to screening as a result of spinal cord injury or multiple sclerosis, determined by documented patient history. In addition:
    [7a] Spinal cord injury patients must have a stable neurological injury level at T1 or below (cervical injuries are excluded) occurring ≥ 6 months prior to screening.
    [7b] Multiple sclerosis patients must be clinically stable in the investigator’s opinion, for ≥ 3 months prior to screening and have an Expanded Disability Status Scale (EDSS) score ≤ 6.5.
    [8] Patient has detrusor overactivity (defined as a phasic rise in bladder pressure during the filling phase determined by urodynamics) demonstrated during the screening period or Day 1 (prior to randomization).
    [9] Patient is able to complete study requirements including bladder diary completion and attend all study visits (telephone and clinic), in the opinion of the investigator.
    [10] 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 an inadequate response or intolerable side effects after at least one month of anticholinergic therapy on an optimized dose.
    [11] For patients taking anticholinergic medication for their neurogenic overactive bladder, dose is stable and patient is willing to maintain same dosing during study participation.
    [12] Patient has a negative pregnancy result if female and of childbearing potential.

    The following criteria are also required for entry into the study at Randomization/Day 1:

    [13] Patient experiences ≥ 14 episodes of urinary incontinence per week with no more than 2 incontinent-free days, determined by completion of patient bladder diary during the screening period.
    [14] Patient currently uses or is willing to use clean intermittent catheterization (CIC) to empty the bladder (indwelling catheter is not permitted). Patients currently on CIC should be willing to maintain an established CIC frequency throughout the study. Caregiver may perform CIC.
    [15] Patients with a negative urine culture result must take an antibiotic medication for 3 days immediately prior to Randomization/Day 1 and agree to continue antibiotic medication for at least 3 days following treatment. Patients with a positive urine culture result indicating urinary tract infection (UTI), must take an antibiotic to which the identified organism is sensitive for at least 5 days immediately prior to Randomization/Day 1 and continue for 3 days following the procedure (or longer as needed) and patient is asymptomatic for UTI on day of treatment. A UTI is defined as either a positive urine culture result with a bacteriuria count of > 10^5 CFU/mL conjoint with a leukocyturia > 5/hpf at screening or a positive urine culture that, in the investigator’s opinion, requires antibiotic therapy.
    E.4Principal exclusion criteria
    [1] Patient has history or evidence of any pelvic or urological abnormalities including but not limited to the following:
    [1a] elevated serum creatinine > 2 times the upper limit of normal (reference range)
    [1b] current or history of hematuria,
    [1ba] if the hematuria is determined to be a pathologic condition or
    [1bb] is uninvestigated
    [1c] interstitial cystitis in the opinion of the investigator
    [1d] bladder stones within 6 months of screening
    [1e] surgery or bladder disease other than detrusor overactivity that may impact bladder function with the exception of surgeries for bladder stones (> 6 months) and stress incontinence, uterine prolapse, rectocele, or cystocele (>1 year) from screening
    [2] Patient has had previous or current botulinum toxin therapy of any serotype for any urological condition or, treatment within 3 months of Randomization/Day 1 for any other condition or use.
    [3] Patient has been immunized for any botulinum toxin serotype.
    [4] Patient discontinued anticholinergic medication for overactive bladder < 21 days prior to Randomization/Day 1.
    [5] Patient has a history or current diagnosis of bladder cancer or has urine cytology results which may indicate bladder cancer not ruled out by investigator at Randomization/Day 1. Suspicious urine cytology abnormalities require the investigator’s assessment to ensure that the findings are not indicative of malignancy.
    [6] Patient is male with previous or current diagnosis of prostate cancer or has a PSA level > 10.0 ng/mL. Patients with a PSA level ≥ 4.0 ng/mL and ≤ 10.0 ng/mL must have prostate cancer ruled out to the satisfaction of the investigator according to local site practice.
    [7] Patient has 24 hour total volume voided > 3000 mL of urine determined by completion of patient bladder diary collected over one consecutive 24 hour period during the 7 day diary collection period prior to Randomization/Day1.
    [8] Patient has a post void residual volume above 200 mL for patients who micturate or have a mixed catheterization/micturition pattern.
    [9] Patient has an active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening.
    [10] Patient uses any anti-platelet or anticoagulant therapy or is using medications with anticoagulative effects within 3 days prior to treatment. Some medications may need to be withheld for > 3 days per clinical judgment of the investigator (refer to Section 8.2.2 Prohibited Medications/Treatments for details).
    [11] Patient has hemophilia or other clotting factor deficiencies or disorders that cause bleeding diatheses.
    [12] Patient has had concurrent treatment or treatment within 6 months of Randomization/Day 1 with capsaicin or resiniferatoxin.
    [13] Patient is currently using or plans to use an implanted or non-implantable electrostimulation/neuromodulation device for treatment of overactive bladder.
    [14] Patient has a known allergy or sensitivity to any components of the study medication, anesthetics or antibiotics or any other products associated with the treatment and general study procedures.
    [15] Patient has any medical condition that may put the patient at increased risk with exposure to BOTOX® including diagnosed myasthenia gravis, Eaton-Lambert syndrome or amyotrophic lateral sclerosis.
    [16] Patient is female and pregnant, nursing or planning a pregnancy during the study, or of childbearing potential and unable or unwilling to use a reliable form of contraception during the study.
    [17] Patient is currently or has previously participated in another therapeutic or device study within 30 days of screening.
    [18] Patient has any condition or situation which, in the investigator’s opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient’s participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Number of episodes of urinary incontinence as recorded by patient bladder diary
    during the 7 days prior to each study visit (telephone and clinic). Primary timepoint
    is at Week 6 following the first treatment.
    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 Yes
    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. 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.8.3 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 2006-07-07. Yes
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 147
    F.4.2.2In the whole clinical trial 416
    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 Decision2006-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-04
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