NCT00876447

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 397 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Botulinum toxin Type A 300U has been discontinued from the study. Patients remaining in the arm containing botulinum toxin Type A 300U will receive botulinum toxin Type A 200U moving forward. Also, the masking of the study is now open-label.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum Toxin Type A 300U	Botulinum toxin Type A 300U injections into the detrusor \> 12 weeks as needed for up to 3 years.
BIOLOGICAL	Botulinum Toxin Type A 200U	Botulinum toxin Type A 200U injections into the detrusor \> 12 weeks as needed for up to 3 years.

Timeline

• Start date: 2009-01-01
• Primary completion: 2013-06-12
• Completion: 2013-09-04
• First posted: 2009-04-06
• Last updated: 2019-05-01
• Results posted: 2014-06-13

Locations

22 sites across 22 countries: United States, Australia, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Italy, Netherlands, New Zealand, Poland, Portugal, Russia, Singapore, Slovakia, South Africa, Spain, Taiwan, Ukraine, United Kingdom