Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01600716
First received: May 15, 2012
Last updated: May 11, 2016
Last verified: May 2016
Results First Received: February 17, 2016  
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
Conditions: Urinary Incontinence
Multiple Sclerosis
Neurogenic Bladder
Interventions: Biological: OnabotulinumtoxinA
Drug: Placebo (Normal Saline)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
OnabotulinumtoxinA OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
Placebo (Normal Saline) Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.

Participant Flow:   Overall Study
    OnabotulinumtoxinA     Placebo (Normal Saline)  
STARTED     66     78  
COMPLETED     59     71  
NOT COMPLETED     7     7  
Other Reasons                 3                 1  
Personal Reasons                 0                 2  
Lost to Follow-up                 0                 2  
Pregnancy                 1                 0  
Lack of Efficacy                 2                 1  
Adverse Event                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
OnabotulinumtoxinA OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
Placebo (Normal Saline) Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
Total Total of all reporting groups

Baseline Measures
    OnabotulinumtoxinA     Placebo (Normal Saline)     Total  
Number of Participants  
[units: participants]
  66     78     144  
Age, Customized  
[units: Participants]
     
<65 years     62     71     133  
≥65 years     4     7     11  
Gender  
[units: Participants]
     
Female     57     70     127  
Male     9     8     17  



  Outcome Measures
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1.  Primary:   Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes   [ Time Frame: Baseline, Week 6 ]

2.  Secondary:   Change From Baseline in Maximum Cystometric Capacity (MCC)   [ Time Frame: Baseline, Week 6 ]

3.  Secondary:   Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)   [ Time Frame: Baseline, Week 6 ]

4.  Secondary:   Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score   [ Time Frame: Baseline, Week 6 ]

5.  Other Pre-specified:   Duration of Treatment Effect Through Week 52   [ Time Frame: Up to 52 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com



Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01600716     History of Changes
Other Study ID Numbers: 191622-117
Study First Received: May 15, 2012
Results First Received: February 17, 2016
Last Updated: May 11, 2016
Health Authority: United States: Food and Drug Administration