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Trial record 8 of 650 for:    Russian Federation | Chile

Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2 (CONTENT2)

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ClinicalTrials.gov Identifier: NCT02660359
Recruitment Status : Terminated (Low recruitment of patients)
First Posted : January 21, 2016
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date  ICMJE January 14, 2016
First Posted Date  ICMJE January 21, 2016
Last Update Posted Date September 16, 2019
Actual Study Start Date  ICMJE July 8, 2016
Actual Primary Completion Date November 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2016)
Change in weekly number of UI episodes [ Time Frame: Baseline, 6 weeks ]
Measured on a 7-day bladder diary
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02660359 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2016)
  • Proportion of subjects with no episodes of UI [ Time Frame: Baseline, 6 weeks ]
    Measured on a 7-day bladder diary
  • Change in incontinence quality of life (I-QoL) total summary score [ Time Frame: Baseline, 6 weeks ]
    Patient-reported outcome questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2
Official Title  ICMJE A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study To Assess The Efficacy And Safety Of One Or More Intradetrusor Treatments Of 600 Or 800 Units Of Dysport® For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due To Spinal Cord Injury Or Multiple Sclerosis
Brief Summary The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® doses (600 units [U] and 800 U), compared to placebo in reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Urinary Incontinence
  • Overactive Bladder
Intervention  ICMJE
  • Biological: Botulinum toxin type A
    600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points.
    Other Names:
    • AbobotulinumtoxinA (Dysport®)
    • Clostridium BTX-A-haemagglutinin complex
  • Biological: Botulinum toxin type A
    800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
    Other Names:
    • AbobotulinumtoxinA (Dysport®)
    • Clostridium BTX-A-haemagglutinin complex
  • Drug: Placebo
    AbobotulinumtoxinA Placebo 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
  • Drug: Placebo
    AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
Study Arms  ICMJE
  • Experimental: 600 U Dysport® Group
    Intervention: Biological: Botulinum toxin type A
  • Placebo Comparator: 600 U Dysport® Placebo Group
    Intervention: Drug: Placebo
  • Experimental: 800 U Dysport® Group
    Intervention: Biological: Botulinum toxin type A
  • Placebo Comparator: 800 U Dysport® Placebo Group
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 29, 2018)
258
Original Estimated Enrollment  ICMJE
 (submitted: January 18, 2016)
408
Actual Study Completion Date  ICMJE July 4, 2019
Actual Primary Completion Date November 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Urinary Incontinence for at least 3 months prior to Screening as a result of Neurogenic Detrusor Overactivity due to Spinal Cord Injury or Multiple Sclerosis.
  • Subjects with Spinal Cord Injury must have a stable neurological injury at T1 level or below which occurred at least 6 months prior to Screening.
  • Subjects with Multiple Sclerosis must be clinically stable in the investigator's opinion, with no exacerbation (relapse) of MS for at least 3 months prior to Screening.
  • Subjects must have had an inadequate response after at least 4 weeks of oral medications used in the treatment of NDO (e.g. anticholinergics, beta-3 agonists) and/or have intolerable side-effects.
  • Routinely performing Clean Intermittent Catheterization (CIC) to ensure adequate bladder emptying.
  • An average of at least two episodes per day of Urinary Incontinence recorded on the screening bladder diary.

Key Exclusion Criteria:

  • Any current condition (other than NDO) that may impact on bladder function.
  • Previous or current, tumour or malignancy affecting the spinal column or spinal cord, or any other unstable cause of SCI.
  • Any condition that will prevent cystoscopic treatment administration or CIC usage, e.g. urethral strictures.
  • Current indwelling bladder catheter, or removal of indwelling bladder catheter less than 4 weeks prior to Screening.
  • BTX-A treatment within 9 months prior to Screening for any urological condition (e.g. detrusor or urethral sphincter treatments).
  • Any neuromodulation/electrostimulation usage for urinary symptoms/incontinence within 4 weeks prior to Screening. Any implanted neuromodulation device must be switched off at least 4 weeks prior to Screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   Russian Federation,   Argentina,   Australia,   Belgium,   Brazil,   Colombia,   France,   Germany,   Israel,   Lithuania,   Mexico,   Peru,   Spain,   Ukraine,   United Kingdom
Removed Location Countries New Zealand
 
Administrative Information
NCT Number  ICMJE NCT02660359
Other Study ID Numbers  ICMJE D-FR-52120-223
2015-000507-44 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ipsen
Study Sponsor  ICMJE Ipsen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP