- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01600716
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)
April 17, 2019 updated by: Allergan
This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
144
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Liege, Belgium
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British Columbia
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Victoria, British Columbia, Canada
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Ontario
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Kitchener, Ontario, Canada
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Olomouc, Czechia
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Garches, France
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Marseille, France
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Warsaw, Poland
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Porto, Portugal
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St. Petersburg, Russian Federation
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Washington
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Mountlake Terrace, Washington, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- At least 3 episodes of urinary incontinence over a 3-day period
- History of Multiple Sclerosis (MS)
- Urinary incontinence not adequately controlled by anticholinergic medication
Exclusion Criteria:
- Current use of intermittent catheter or indwelling catheter to manage urinary incontinence
- Previous or current botulinum toxin therapy of any serotype for any urological condition
- Previous or current botulinum toxin therapy of any serotype for any non-urological condition within the last 12 weeks
- Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral Sclerosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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 100 U injection.
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OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1 in the onabotulinumtoxinA 100 U arm.
After a minimum of 12 weeks, patients in both the onabotulinumtoxinA 100 U arm and the placebo arm could request/qualify for an onabotulinumtoxinA injection.
Other Names:
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Other: 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.
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OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1 in the onabotulinumtoxinA 100 U arm.
After a minimum of 12 weeks, patients in both the onabotulinumtoxinA 100 U arm and the placebo arm could request/qualify for an onabotulinumtoxinA injection.
Other Names:
Placebo (normal saline) is administered into the detrusor at Day 1.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes
Time Frame: Baseline, Week 6
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Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary.
The number of episodes of urinary incontinence is recorded over a 3-day period the week of the study visit.
A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change indicates an increase in incontinence episodes (worsening).
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Baseline, Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Maximum Cystometric Capacity (MCC)
Time Frame: Baseline, Week 6
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MCC represents the maximum volume of urine the bladder holds.
A positive number change from baseline represents an improvement (increase) in the maximum volume of urine the bladder holds and a negative number change from baseline represents a worsening (decrease) in the maximum volume of urine the bladder holds.
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Baseline, Week 6
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Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)
Time Frame: Baseline, Week 6
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Maximum detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle.
A negative number change from baseline indicates an improvement in pressure and a positive number change from baseline indicates a worsening in pressure.
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Baseline, Week 6
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Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Time Frame: Baseline, Week 6
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The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives.
Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL).
The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL).
A positive change from baseline represents an improvement and a negative change from baseline represents a worsening.
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Baseline, Week 6
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Duration of Treatment Effect Through Week 52
Time Frame: Up to 52 Weeks
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The duration of treatment effect is the time to patient request for retreatment.
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Up to 52 Weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 13, 2012
Primary Completion (Actual)
April 4, 2014
Study Completion (Actual)
March 27, 2015
Study Registration Dates
First Submitted
May 15, 2012
First Submitted That Met QC Criteria
May 15, 2012
First Posted (Estimate)
May 17, 2012
Study Record Updates
Last Update Posted (Actual)
April 30, 2019
Last Update Submitted That Met QC Criteria
April 17, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Neurologic Manifestations
- Urination Disorders
- Elimination Disorders
- Multiple Sclerosis
- Sclerosis
- Urinary Incontinence
- Enuresis
- Urinary Bladder, Neurogenic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- 191622-117
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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