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

Study Identifier
191622-094
CT.gov Identifier
NCT00876447
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Bladder Disorder - Overactive Bladder
    • Study Drug
  • Botulinum Toxin Type A 300U
  • Botulinum Toxin Type A 200U
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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).

    Study Locations

    Location
    Status
    Location
    Middlebury, Connecticut, United States
    Status
    Not applicable
    Location
    Randwick, Australia
    Status
    Not applicable
    Location
    Innsbruck, Austria
    Status
    Not applicable
    Location
    Ghent, Belgium
    Status
    Not applicable
    Location
    Rio de Janeiro, Brazil
    Status
    Not applicable
    Location
    Victoria, British Columbia, Canada
    Status
    Not applicable
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