Trials / Terminated
TerminatedNCT02660359
Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 258 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Botulinum toxin type A | 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points. |
| BIOLOGICAL | Botulinum toxin type A | 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points |
| 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 |
Timeline
- Start date
- 2016-07-08
- Primary completion
- 2018-11-09
- Completion
- 2019-07-04
- First posted
- 2016-01-21
- Last updated
- 2022-09-28
- Results posted
- 2021-06-16
Locations
82 sites across 16 countries: Argentina, Australia, Belgium, Brazil, Chile, Colombia, France, Germany, Israel, Lithuania, Mexico, Peru, Russia, Spain, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02660359. Inclusion in this directory is not an endorsement.