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NCT02660138 · ClinicalTrials.gov registry record · Phase 3
Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1
A Phase 3 study, sponsored by Ipsen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 227
- Enrollment target
NCT02660138: Clinical Trial Phase 3 study, sponsored by Ipsen.
NCT02660138 is a Phase 3 study that was terminated before completion, run by Ipsen. The registered enrollment target is 227 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02660138, a Phase 3 study, was terminated before completion, sponsored by Ipsen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 227 participants
- Enrollment target
Study Summary
The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® (AbobotulinumtoxinA) 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).
Primary Outcome
The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The least square (LS) mean of the change in weekly number of UI episodes at 6 weeks after the first study treatment was calculated using a mixed model repeated measures (MMRM) analysis.
Interventions
- DRUG Placebo
- BIOLOGICAL Botulinum toxin type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2016-03 |
| Est. Completion | 2019-02-14 |
| Phase | Phase 3 |
Why NCT02660138 stopped before completion
NCT02660138 is an interventional study that assigns participants to a tested intervention. The registered 227 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02660138 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02660138 about?
NCT02660138 is a clinical study titled "Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1". The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® (AbobotulinumtoxinA) 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 spina...
What is the current status of trial NCT02660138?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 227 participants. The study started on 2016-03. Estimated completion is 2019-02-14.
What interventions are being tested in trial NCT02660138?
The interventions under investigation include: Placebo (DRUG), Botulinum toxin type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT02660138?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02660138's enrollment target sits among peer trials
227 1310th of 2000 higher than 691 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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