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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Urinary Incontinence, Multiple Sclerosis, Neurogenic Bladder

In brief

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.

Key facts

Study ID

NCT01600716

Run by

Allergan

People needed

144

Starts

2012-06-13

Expected to finish

2015-03-27

Last updated by the study team

2019-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Mountlake Terrace, Washington, United States
• Study site — Liège, Belgium
• Study site — Victoria, British Columbia, Canada
• Study site — Kitchener, Ontario, Canada
• Study site — Olomouc, Czechia
• Study site — Garches, France
• Study site — Marseille, France
• Study site — Warsaw, Poland
• Study site — Porto, Portugal
• Study site — Saint Petersburg, Russia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.