Study Stopped
In agreement with FDA the study was terminated based on data available.
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
1 other identifier
interventional
41
4 countries
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2007
Longer than P75 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2007
CompletedFirst Posted
Study publicly available on registry
February 23, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
January 24, 2014
CompletedJanuary 24, 2014
December 1, 2013
5.5 years
February 21, 2007
December 9, 2013
December 9, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
Change From Baseline in Forced Vital Capacity (FVC)
Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible, at Baseline and Week 6. A positive change from Baseline indicated improvement.
Baseline, Week 6
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FEV1, the maximum amount of air exhaled in one second, at Baseline and Week 6. The highest value at each time-point was recorded. A positive change from Baseline indicated improvement.
Baseline, Week 6
Change From Baseline in FEV1/FVC Ratio
The FEV1/FVC ratio was calculated by dividing the FEV1 value by the FVC value representing the portion (or ratio) of FVC exhaled in one second. A positive change from Baseline indicated improvement.
Baseline, Week 6
Secondary Outcomes (3)
Change From Baseline in the Number of Urinary Incontinence Episodes
Baseline, Week 6
Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP)
Baseline, Week 6
Change From Baseline in Maximum Cystometric Capacity (MCC)
Baseline, Week 6
Other Outcomes (2)
Number of Participants With at Least a 15% Decrease From Baseline in FVC
Baseline, Weeks 2, 6 and 12
Number of Participants With at Least a 20% Decrease From Baseline in FVC
Baseline, Weeks 2, 6 and 12
Study Arms (4)
botulinum toxin Type A 200U
EXPERIMENTALBotulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
botulinum toxin Type A 300U
EXPERIMENTALBotulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
Placebo/botulinum toxin Type A 200U
OTHERPlacebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
Placebo/botulinum toxin Type A 300U
OTHERPlacebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 300U injection (200U after discontinuation of 300U) after a minimum of 12 weeks (if applicable).
Interventions
Botulinum toxin Type A injection into the detrusor.
Placebo (Normal Saline) injection into the detrusor.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (4)
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Herston, Queensland, Australia
Unknown Facility
Victoria, British Columbia, Canada
Unknown Facility
Chennai, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2007
First Posted
February 23, 2007
Study Start
June 1, 2007
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
January 24, 2014
Results First Posted
January 24, 2014
Record last verified: 2013-12