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)

• Status: Completed
• Trial end date: 2015-03-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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