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

Completed · Phase 3

Conditions studied: Overactive Bladder

In brief

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).

Key facts

Study ID

NCT00876447

Run by

Allergan

People needed

397

Starts

2009-01-01

Expected to finish

2013-09-04

Last updated by the study team

2019-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• History or evidence of pelvic or urologic abnormality.
• Previous or current diagnosis of bladder or prostate cancer.

Where it is running

• Study site — Middlebury, Connecticut, United States
• Study site — Randwick, Australia
• Study site — Innsbruck, Austria
• Study site — Ghent, Belgium
• Study site — Rio de Janeiro, Brazil
• Study site — Victoria, British Columbia, Canada
• Study site — Ostrava, Czechia
• Study site — Salouël, France
• Study site — Kiel, Germany
• Study site — Florence, Italy
• Study site — Amsterdam, Netherlands
• Study site — Epsom, New Zealand
• Study site — Poznan, Poland
• Study site — Porto, Portugal
• Study site — Moscow, Russia
• Study site — Singapore, Singapore
• Study site — Prešov, Slovakia
• Study site — Pretoria, South Africa
• Study site — Santa Cruz de Tenerife, Spain
• Study site — Hualien City, Taiwan
• Study site — Kiev, Ukraine
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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