Status:
COMPLETED
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
Lead Sponsor:
Allergan
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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. Thi...
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, th...
Eligibility Criteria
Inclusion
- Patient has participated in study 191622-515 or 191622-516 and the following criteria fulfilled:
- Patient completed at least 52 weeks in the preceding study.
- No longer than 6 months has elapsed since completion of the preceding study
- Patient has not received any prohibited medications during any intervening period between the preceding study and this long-term study.
Exclusion
- History or evidence of pelvic or urologic abnormality.
- Previous or current diagnosis of bladder or prostate cancer.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2013
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT00876447
Start Date
January 1 2009
End Date
September 4 2013
Last Update
May 1 2019
Active Locations (22)
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1
Middlebury, Connecticut, United States
2
Randwick, Australia
3
Innsbruck, Austria
4
Ghent, Belgium