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NCT00461292 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

A Phase 3 study, sponsored by Allergan.

Completed
Registry status
Phase 3
Development phase
275
Enrollment target

NCT00461292: Completed Phase 3 study, sponsored by Allergan.

NCT00461292 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 275 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00461292, a Phase 3 study, has completed, sponsored by Allergan.

COMPLETED
Registry status
Phase 3
Development phase
275 participants
Enrollment target

Study Summary

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients

Primary Outcome

Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

Interventions

  • BIOLOGICAL botulinum toxin Type A (200U)
  • BIOLOGICAL botulinum toxin Type A (300U)
  • OTHER Normal saline (Placebo); botulinum toxin Type A (200U)
  • OTHER Normal saline (Placebo); botulinum toxin Type A (300U)

Trial Details

FieldValue
Enrollment Target 275 participants
Start Date 2007-05
Est. Completion 2010-04
Phase Phase 3
Allergan

314 total trials

What the finished NCT00461292 record still lists

NCT00461292 is an interventional study that assigns participants to a tested intervention. The registered 275 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 (64% lower).

The record links to 0 conditions, and to 4 interventions - of which botulinum toxin Type A (200U) is the first listed.

NCT00461292 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00461292 about?

NCT00461292 is a clinical study titled "Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder". The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients

What is the current status of trial NCT00461292?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 275 participants. The study started on 2007-05. Estimated completion is 2010-04.

What interventions are being tested in trial NCT00461292?

The interventions under investigation include: botulinum toxin Type A (200U) (BIOLOGICAL), botulinum toxin Type A (300U) (BIOLOGICAL), Normal saline (Placebo); botulinum toxin Type A (200U) (OTHER), Normal saline (Placebo); botulinum toxin Type A (300U) (OTHER).

Who is sponsoring clinical trial NCT00461292?

This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00461292's enrollment target sits among peer trials

275 1206th of 2000 higher than 794 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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Source: ClinicalTrials.gov NCT00461292, the US trial registry maintained by the National Library of Medicine. NCT00461292 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.