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NCT01600716 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 144
- Enrollment target
NCT01600716: Completed Phase 3 study, sponsored by Allergan.
NCT01600716 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 144 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01600716, a Phase 3 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 144 participants
- Enrollment target
Study 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.
Primary Outcome
Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. The number of episodes of urinary incontinence is recorded over a 3-day period the week of the study visit. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change indicates an increase in incontinence episodes (worsening).
Interventions
- BIOLOGICAL OnabotulinumtoxinA
- DRUG Placebo (Normal Saline)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2012-06-13 |
| Est. Completion | 2015-03-27 |
| Phase | Phase 3 |
What the finished NCT01600716 record still lists
NCT01600716 is an interventional study that assigns participants to a tested intervention. The registered 144 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 (81% lower).
The record links to 0 conditions, and to 2 interventions - of which OnabotulinumtoxinA is the first listed.
NCT01600716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01600716 about?
NCT01600716 is a clinical study titled "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)". 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.
What is the current status of trial NCT01600716?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 144 participants. The study started on 2012-06-13. Estimated completion is 2015-03-27.
What interventions are being tested in trial NCT01600716?
The interventions under investigation include: OnabotulinumtoxinA (BIOLOGICAL), Placebo (Normal Saline) (DRUG).
Who is sponsoring clinical trial NCT01600716?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01600716's enrollment target sits among peer trials
144 1559th of 2000 higher than 442 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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