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

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Biological: Botulinum Toxin Type A 200U; Biological: Botulinum Toxin Type A 300U

Study type: Interventional

Funder types: Industry

Identifiers

NCT00876447

191622-094

Details and patient eligibility

About

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).

Full 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.

Enrollment: 397 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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397 participants in 2 patient groups

Botulinum Toxin Type A 300U

Experimental group

Description:

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

Treatment:

Biological: Botulinum Toxin Type A 300U

Botulinum Toxin Type A 200U

Experimental group

Description:

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

Treatment:

Biological: Botulinum Toxin Type A 200U