CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 397 enrolled
Drug / intervention
Botulinum Toxin Type A 300U +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00876447
NCT00876447Phase 3Completed
CompareCT.gov

A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis

Allergan·interventional·Posted Apr 6, 2009·Updated May 1, 2019

In Brief

A Phase 3 clinical trial evaluating Botulinum Toxin Type A 300U and Botulinum Toxin Type A 200U for Overactive Bladder. Completed, enrolled 397 participants across 22 sites in 22 countries.

Detailed Summary

The purpose of this study is to assess the long-term safety and effectiveness of botulinum toxin type A on patients with overactive bladder as a result of spinal cord injury or multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376 and NCT00461292).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesAustralia, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Italy, Netherlands, New Zealand, Poland, Portugal, Russia, Singapore, Slovakia, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 6, 2009
Enrollment StartJan 1, 2009
Primary CompletionJun 12, 2013
Study CompletionSep 4, 2013
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 17.2 years ago

Interventions

Botulinum Toxin Type A 300Ubiological

Botulinum toxin Type A 300U injections into the detrusor \> 12 weeks as needed for up to 3 years.

Botulinum Toxin Type A 200Ubiological

Botulinum toxin Type A 200U injections into the detrusor \> 12 weeks as needed for up to 3 years.