Trials / Completed
CompletedNCT01600716
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 144 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | OnabotulinumtoxinA | OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1 in the onabotulinumtoxinA 100 U arm. After a minimum of 12 weeks, patients in both the onabotulinumtoxinA 100 U arm and the placebo arm could request/qualify for an onabotulinumtoxinA injection. |
| DRUG | Placebo (Normal Saline) | Placebo (normal saline) is administered into the detrusor at Day 1. |
Timeline
- Start date
- 2012-06-13
- Primary completion
- 2014-04-04
- Completion
- 2015-03-27
- First posted
- 2012-05-17
- Last updated
- 2019-04-30
- Results posted
- 2016-03-22
Locations
10 sites across 8 countries: United States, Belgium, Canada, Czechia, France, Poland, Portugal, Russia
Source: ClinicalTrials.gov record NCT01600716. Inclusion in this directory is not an endorsement.