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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   43216   clinical trials with a EudraCT protocol, of which   7153   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) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
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    Summary
    EudraCT Number:2006-006299-39
    Sponsor's Protocol Code Number:191622-082-01
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-06-13
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2006-006299-39
    A.3Full title of the trial
    A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment
    A.4.1Sponsor's protocol code number191622-082-01
    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
    B.1.3.4CountryUnited States
    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.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 Yes
    D.2.1.1.1Trade name BOTOX®
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration numbervials of 100 to Allergan units
    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 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
    Patients with urinary incontinence due to neurogenic detrusor overactivity as a result of spinal cord injury or multiple sclerosis who have not been adequately managed with anticholinergic therapy and have neurological respiratory impairment.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10046543
    E.1.2Term Urinary incontinence
    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 2 dose levels 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 and have neurological respiratory impairment.
    E.2.2Secondary objectives of the trial
    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 lbs).
    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 Day -21 as a result of spinal cord injury (SCI) or multiple sclerosis (MS), determined by documented patient history. In addition:
    • Spinal cord injured patients must have a stable neurological injury between cervical level 5 (C5) and cervical level 8 (C8), inclusively as determined by the neurological definition of SCI; complete or incomplete. The spinal cord injury must have occurred ≥ 12 months prior to Screening Day -21.
    • Multiple sclerosis patients must be clinically stable, in the investigator’s opinion, for ≥ 3 months prior to Screening and through Randomization/Day 1. Patients must have an Expanded Disability Status Scale (EDSS) score between 7.0 and 8.0, inclusively.
    8. Patient has the ability to perform acceptable and reproducible pulmonary function testing as determined by the investigator and pulmonologist.
    9. Patient has a Forced Vital Capacity (FVC) between 50% and 80% of predicted value on two separate testing days during Screening (Day -21 to Day -1). Note: The difference between the largest FVC observed on each testing day must not exceed 20%. There should be at least 7 days between the two screening PFTs and the second PFT must occur within 0-5 days prior to Randomization/Day 1 Visit.
    10. Patient has detrusor overactivity (defined as a phasic rise in bladder pressure during the filling phase as determined by urodynamics) demonstrated during the Screening period (Day -21 to -1) ) or Randomization/Day 1.
    11. Patient is able to complete study requirements and attend all study visits (telephone and clinic), in the opinion of the investigator.
    12. 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 to or intolerable side effects while taking an optimized dose for at least one month.
    13. For patients taking anticholinergic medication for their neurogenic overactive bladder, dose is stable and patient is willing to maintain same dosing during study participation.
    14. Patient has a negative pregnancy test result if female and of childbearing potential.
    15. Both MS and SCI patients must be willing to use IC to empty the bladder and maintain an established catheterization frequency throughout the study. Caregiver may perform IC for patient, if patient is unable to do this. (Indwelling catheters and suprapubic catheters are not permitted).
    16. Patient experiences ≥ 4 episodes of urinary incontinence (leakage) over 3 days determined by completion of a bladder diary during the Screening period.
    E.4Principal exclusion criteria
    1. 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
    2. Patient has been immunized for any botulinum toxin serotype.
    3. Patient has history or evidence of any significant pelvic or urological abnormality including but not limited to the following (described in protocol):
    - elevated serum creatinine >2 times the upper limit of normal (reference range)
    - history of or current hematuria, 1) if the hematuria is determined to be due to a - pathologic condition or 2) is uninvestigated.
    - interstitial cystitis in the opinion of the investigator
    - bladder stones within 6 months of Screening Day - 21
    - 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 Day -21)
    4. Patient is male with previous or current diagnosis of prostate cancer. Patients with a PSA level greater than 4.0 ng/mL at Screening Day -21 will require a biopsy to rule out prostate cancer, unless a prostatic biopsy has been performed within the past 12 months.
    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 the investigator at Randomization/Day 1. Suspicious urine cytology abnormalities require the investigator’s assessment that the findings are not indicative of malignancy.
    6. Patient has discontinued anticholinergic medication for the treatment of overactive bladder < 21 days prior to Randomization/Day 1.
    7. Patient has an untreated or symptomatic (e.g. fever, recent change in neurological status) urinary tract infection (UTI) on Randomization/Day 1.
    8. Patient has a post void residual volume above 150 mL for patients who micturate or have a mixed catheterization/spontaneous micturition pattern.
    9. Patient has an active genital infection, other than genital warts, within 4 weeks prior to Screening Day -21.
    10. Patient has an acute respiratory tract infection at during (Screening Day -21 to Day -1) or Randomization/Day 1. Patient may qualify for re-screening upon clinical resolution and stabilization (one month, or longer based on the investigator’s opinion, has elapsed after clinical resolution without recurrent symptoms).
    11. Patient has a clinically significant abnormal CXR finding. Patient may qualify for re-screening upon resolution, or the CXR finding is no longer considered clinically significant.
    12. Patient has clinically significant intrinsic lung disease (e.g. sarcoidosis, pulmonary fibrosis, bronchiectasis).
    13. Asthmatics, whose disease is not stable (i.e., have had exacerbation(s) of asthma within 3 months prior to Screening Day -21). Note: Stable, preventative respiratory medications/therapy are permitted.
    14. Patient has an acute exacerbation of COPD within 3 months prior to Screening Day -21.
    15. Patient has had a pulmonary embolus (PE) within 6 months of Screening Day -21, or a history of recurrent pulmonary emboli (i.e., a diagnosis of PE on more than one occasion per lifetime).
    16. Patient has aspiration pneumonia, aspiration pneumonitis or acute respiratory failure within 12 months prior to Screening Day -21.
    17. Patient requires supplemental oxygen and/or ventilatory support.
    18. Patient has evidence of carbon dioxide (CO2) retention as indicated by serum bicarbonate level greater than the upper limit of normal (reference range) at Screening Day -21.
    19. Patient has used any antiplatelet 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).
    20. Patient has hemophilia or other clotting factor deficiencies or disorders that may cause bleeding diatheses.
    21. Patient is currently using, or plans to use, an implanted or non-implantable electrostimulation/neuromodulation device for treatment of overactive bladder.
    22. Patient is currently being treated with an intrathecal baclofen pump.
    23. Patient has a known allergy or sensitivity to any component of the study medication, anesthetics or antibiotics or any other products associated with the injection and general study procedures.
    24. 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.
    E.5 End points
    E.5.1Primary end point(s)
    • Number of episodes of urinary incontinence as recorded in the patient bladder diary
    • Number of episodes of voiding and method (catheterization or voluntary) as recorded in the patient bladder diary
    • Urodynamic parameters, as detailed in the protocol. Urodynamic studies will be conducted according to International Continence Society (ICS) standard guidelines (Homma et al, 2002) and results will be assessed by an independent central urodynamic reviewer.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 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 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 Information not present in EudraCT
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 135
    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 Decision2007-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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