Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)

Study Identifier
191622-117
CT.gov Identifier
NCT01600716
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Bladder Disorder - Overactive Bladder
  • Multiple Sclerosis (MS)
    • Study Drug
  • OnabotulinumtoxinA
  • Placebo (Normal Saline)
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * At least 3 episodes of urinary incontinence over a 3-day period * History of Multiple Sclerosis (MS) * Urinary incontinence not adequately controlled by anticholinergic medication
    Exclusion Criteria:
    * Current use of intermittent catheter or indwelling catheter to manage urinary incontinence * Previous or current botulinum toxin therapy of any serotype for any urological condition * Previous or current botulinum toxin therapy of any serotype for any non-urological condition within the last 12 weeks * Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral Sclerosis

    Protocol Summary

    This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.

    Study Locations

    Location
    Status
    Location
    Mountlake Terrace, Washington, United States
    Status
    Not applicable
    Location
    Liège, Belgium
    Status
    Not applicable
    Location
    Victoria, British Columbia, Canada
    Status
    Not applicable
    Location
    Kitchener, Ontario, Canada
    Status
    Not applicable
    Location
    Olomouc, Czech Republic
    Status
    Not applicable
    Location
    Garches, France
    Status
    Not applicable
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