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    Summary
    EudraCT Number:2009-009216-53
    Sponsor's Protocol Code Number:191622-094
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-25
    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 number2009-009216-53
    A.3Full title of the trial
    A Multicenter, Long-term Follow-up Study of the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Long-term Follow-up Study of the Safety and Efficacy of
    BOTOX® (Botulinum Toxin Type A) in Patients with Urinary Incontinence Due to Neurogenic bladder
    A.4.1Sponsor's protocol code number191622-094
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00876447
    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 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 supportAllergan Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd.
    B.5.2Functional name of contact pointEU Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Marlow International, Parkway,
    B.5.3.2Town/ cityMarlow
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 01628494444
    B.5.5Fax number+44 01628494449
    B.5.6E-mailml-eu_reg_affairs@allergan.com
    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 Ltd
    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.3.1Product nameBotox®
    D.3.2Product code 9060X
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    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 nameBotox purified neurotoxin complex
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    E.1.1.1Medical condition in easily understood language
    Patients with urinary incontinence caused by neurogenic bladder as a
    result of Spinal Cord Injury or Multiple Sclerosis.
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    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
    To evaluate the long-term safety and maintenance of efficacy of BOTOX® 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
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient has successfully completed participation in study 191622-515 or 191622-516 and the following criteria are fulfilled:
    • Patient has completed at least 52 weeks in the preceding study, with at least 12 weeks of follow-up after the last treatment (i.e., completed the applicable week 52 exit visit or completed the applicable week 12/exit visit after last treatment).
    • No longer than 6 months has elapsed since completion of the preceding study
    2. Written informed consent has been obtained.
    3 Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained.
    4. Written Data Protection Consent (European sites only) has been obtained.
    5. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
    6. Patient is able to complete study requirements including diary completion and attend all study visits, in the opinion of the investigator.
    7. Patient currently uses or is willing to use clean intermittent catheterization (CIC) to empty the bladder (indwelling catheter is not permitted). Caregiver may perform CIC.
    8. Patient has a negative pregnancy result if female and of childbearing potential.
    9. Patient weighs more than or equal to 50 kg (110 lb).


    Additionally, for the patient to qualify for treatment, the following criteria must be satisfied (the request for treatment can occur either at a scheduled visit or between scheduled visits):

    • Patient must initiate request for treatment
    • Patient reports at least 1 urinary incontinence episode in 3 days as determined by completion of patient bladder diary (over 3 consecutive days) prior to visit.
    • A minimum of 12 weeks must have elapsed since previous study treatment (either in the preceding study or in the current study) and treatment cannot occur later than 144 weeks from Study Entry/Day 1
    • A minimum of 12 weeks must have elapsed since any BOTOX® (botulinum toxin type A) treatment for any non-urological condition (use of any botulinum toxin of any serotype, is prohibited for the treatment of urological conditions, except for treatment administered as part of study participation)


    Once the above criteria have been met, the patient will be considered qualified for treatment. The following criteria must be met prior to the patient being treated with study medication:

    • Investigator determines treatment appropriate and no condition or situation exists which, in the investigator’s opinion, puts the patient at significant risk from treatment
    • Patient has discontinued any antiplatelet or anticoagulant therapy or medications with
    anticoagulative effects within at least 3 days prior to treatment (some medications may need to be withheld for >3 days per clinical judgment of the investigator). If needed, low molecular weight heparin can be given up to 24 hours prior to treatment
    • Negative pregnancy test result for women of childbearing potential
    • In the investigator’s opinion, patient is asymptomatic for urinary tract infection (UTI) on day of treatment
    • Patient has taken appropriate antibiotic medication:
    a) For patients with a negative urine culture result, an antibiotic must be taken for at least 3 days immediately prior to study treatment and continued for at least 3 days following the study treatment procedure (or longer as needed)
    b) For patients with a positive urine culture (defined as a urine culture result with a bacteriuria count of > 105 CFU/mL), an antibiotic to which the identified organism is sensitive must be taken at least 5 days immediately prior to study treatment and continued for 3 days following the study treatment procedure (or longer as needed)
    • No occurrence of bladder stones
    • For male patients at treatment one only: if PSA results are ≥ 4.0 ng/mL and ≤ 10.0 ng/mL, prostate cancer must be ruled out to the satisfaction of the investigator according to local site practice prior to treatment. If the PSA is greater than 10.0 ng/mL, the patient must be discontinued from the study.

    E.4Principal exclusion criteria
    1. Patient has evidence of any pelvic or urological abnormalities including but not
    limited to the following:
    • interstitial cystitis in the opinion of the investigator
    • presence of bladder stones, including any bladder stones detected in the previous study
    • surgery or bladder disease other than detrusor overactivity that may impact bladder function (with the exception of surgery performed more than 1 year from screening in the preceding study for stress incontinence, uterine prolapse, rectocele, or cystocele)
    2. Patient has received botulinum toxin therapy of any serotype for any urological condition (except for treatment administered as part of study participation in the preceding protocol).
    3. Patient has had treatment within 12 weeks of Study Entry/Day 1 of botulinum toxin of any serotype for any non-urological condition
    4. Patient has been immunized for any botulinum toxin serotype.
    5. Patient has a history, or current diagnosis of prostate cancer.
    6. Patient has a history, or current diagnosis of bladder cancer.
    7. Patient has hemophilia or other clotting factor deficiencies or disorders that cause bleeding diatheses.
    8. Patient has concurrent treatment or treatment within 6 months of Study Entry/Day 1 with intravesical capsaicin, resiniferatoxin, or any other intravesical treatment for overactive bladder.
    9. Patient is currently using or plans to use an implanted or non-implantable electrostimulation/neuromodulation device for the treatment of overactive bladder or a baclofen pump.
    10. Patient has a known allergy or sensitivity to any botulinum toxin preparation, (including the study medication preparation), anesthetics or antibiotics or any other products associated with the treatment and general study procedures.
    11. 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.
    12. 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.
    13. 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.
    14. Patient is currently participating in, or has previously participated in another therapeutic or device study since exiting study 191622-515 or 191622-516.
    15. Any study drug related or study treatment related serious adverse event (SAE) 191622-515 or 191622-516 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 3 consecutive days prior to each study visit. The change from baseline in the daily average frequency of episodes of urinary incontinence. The timepoint of primary interest is week 6 after each treatment in this study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Number of episodes of urinary incontinence as recorded by patient
    bladder diary during the 3 consecutive days prior to each study visit. The change from baseline in the daily average frequency of episodes of
    urinary incontinence. The timepoint of primary interest is week 6 after
    each treatment in this study.
    E.5.2Secondary end point(s)
    · I-QOL - Incontinence Quality of Life Instrument Total Summary Score
    · Total volume voided recorded over one 24-hour period as recorded by
    patient bladder diary for all voids (catheterization and voluntary)
    · Number of episodes of voiding and method (catheterization and voluntary) as recorded by patient bladder diary
    · Time to patient request for re-treatment, time to qualification for retreatment and time between treatments.
    E.5.2.1Timepoint(s) of evaluation of this end point
    These will be measured for the duration of the study.
    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.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 Information not present in EudraCT
    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 Information not present in EudraCT
    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.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    New Zealand
    Russian Federation
    Singapore
    South Africa
    Taiwan
    Ukraine
    United States
    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
    As per protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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 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: 398
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 2009-06-25. 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 146
    F.4.2.2In the whole clinical trial 500
    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 Decision2009-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-04
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