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NCT01852058 · ClinicalTrials.gov registry record · Phase 3
A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity
A Phase 3 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 95
- Enrollment target
NCT01852058: Completed Phase 3 study, sponsored by Allergan.
NCT01852058 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 95 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01852058, a Phase 3 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 95 participants
- Enrollment target
Study Summary
This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA (botulinum toxin Type A; BOTOX®) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in participants who successfully completed Study 191622-120 (NCT01852045).
Primary Outcome
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the re
Interventions
- BIOLOGICAL OnabotulinumtoxinA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2014-01-11 |
| Est. Completion | 2019-10-03 |
| Phase | Phase 3 |
What the finished NCT01852058 record still lists
NCT01852058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which OnabotulinumtoxinA is the first listed.
NCT01852058 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01852058 about?
NCT01852058 is a clinical study titled "A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity". This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA (botulinum toxin Type A; BOTOX®) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in participants who successfully completed Study 191622-120 (NCT01852045).
What is the current status of trial NCT01852058?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 95 participants. The study started on 2014-01-11. Estimated completion is 2019-10-03.
What interventions are being tested in trial NCT01852058?
The interventions under investigation include: OnabotulinumtoxinA (BIOLOGICAL).
Who is sponsoring clinical trial NCT01852058?
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 NCT01852058's enrollment target sits among peer trials
95 1719th of 2000 higher than 282 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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