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

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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

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

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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