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Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

This study has been terminated.
(In agreement with FDA the study was terminated based on data available.)
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00439140
First received: February 21, 2007
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.


Condition Intervention Phase
Overactive Bladder
 Biological: botulinum toxin Type A 200U
Biological: botulinum toxin Type A 300U
Drug: Normal Saline (Placebo)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Forced Vital Capacity [ Time Frame: Week 2 ] [ Designated as safety issue: Yes ]
  • Forced Expiratory Volume [ Time Frame: Week 2 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pulmonary function [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
  • Number of episodes of urinary incontinence (urodynamics) [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  • Peak (amplitude) detrusor pressure (urodynamics) [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  • Maximum cystometric capacity (urodynamics) [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: June 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: botulinum toxin Type A 200U
botulinum toxin Type A 200 U injection on Day 1 followed by botulinum toxin Type A 200 U injection > 12 weeks.
 Biological: botulinum toxin Type A 200U
botulinum toxin Type A 200 U injection on Day 1 followed by botulinum toxin Type A 200 U injection > 12 weeks or botulinum toxin Type A 200 U injection > 12 weeks.
Other Name: BOTOX®
Experimental: botulinum toxin Type A 300U
botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection > 12 weeks.
 Biological: botulinum toxin Type A 300U
botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection > 12 weeks or botulinum toxin Type A 300 U injection > 12 weeks.
Other Name: BOTOX®
Placebo followed by botulinum toxin Type A 200U
Placebo (Normal Saline) injection on Day 1 followed by botulinum toxin Type A 200U injection > 12 weeks.
 Biological: botulinum toxin Type A 200U
botulinum toxin Type A 200 U injection on Day 1 followed by botulinum toxin Type A 200 U injection > 12 weeks or botulinum toxin Type A 200 U injection > 12 weeks.
Other Name: BOTOX®
Drug: Normal Saline (Placebo)
Placebo (Normal Saline) injection on Day 1.
Placebo followed by botulinum toxin Type A 300U
Placebo (Normal Saline) injection on Day 1 followed by botulinum toxin Type A 300 U injection > 12 weeks.
 Biological: botulinum toxin Type A 300U
botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection > 12 weeks or botulinum toxin Type A 300 U injection > 12 weeks.
Other Name: BOTOX®
Drug: Normal Saline (Placebo)
Placebo (Normal Saline) injection on Day 1.

Detailed Description:

Botulinum toxin Type A 300U has been discontinued from the study. Patients remaining in the study who were allocated to receive botulinum toxin Type A 300U at treatment 2 (and had not yet received it) will receive botulinum toxin Type A 200U instead.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
  • Inadequate response to anticholinergic medication used to treat overactive bladder.
  • Neurological respiratory impairment and abnormal pulmonary function test results

Exclusion Criteria:

  • History or evidence of pelvic or urologic abnormality
  • Previous or current diagnosis of bladder or prostate cancer
  • Symptomatic or untreated urinary tract infection at time of enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439140

Locations
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Australia, Queensland
Brisbane, Queensland, Australia
Canada, British Columbia
Victoria, British Columbia, Canada
India
Chennai, India
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00439140     History of Changes
Other Study ID Numbers: 191622-082
Study First Received: February 21, 2007
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Trichostatin A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 22, 2013