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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

NCT00876447 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 397

Last updated 2019-05-01

Study results available
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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).

Conditions

Interventions

BIOLOGICAL

Botulinum Toxin Type A 300U

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

BIOLOGICAL

Botulinum Toxin Type A 200U

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

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-01
Primary Completion
2013-06-12
Completion
2013-09-04

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • Russia
  • Singapore
  • Slovakia
  • South Africa
  • Spain
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00876447 on ClinicalTrials.gov