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)
1 other identifier
interventional
144
8 countries
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2012
Typical duration for phase_3
10 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
May 15, 2012
CompletedFirst Posted
Study publicly available on registry
May 17, 2012
CompletedStudy Start
First participant enrolled
June 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2015
CompletedResults Posted
Study results publicly available
March 22, 2016
CompletedApril 30, 2019
April 1, 2019
1.8 years
May 15, 2012
February 17, 2016
April 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes
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).
Baseline, Week 6
Secondary Outcomes (3)
Change From Baseline in Maximum Cystometric Capacity (MCC)
Baseline, Week 6
Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)
Baseline, Week 6
Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Baseline, Week 6
Other Outcomes (1)
Duration of Treatment Effect Through Week 52
Up to 52 Weeks
Study Arms (2)
OnabotulinumtoxinA
EXPERIMENTALOnabotulinumtoxinA 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.
Placebo (Normal Saline)
OTHERPlacebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
Interventions
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.
Placebo (normal saline) is administered into the detrusor at Day 1.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (10)
Unknown Facility
Mountlake Terrace, Washington, United States
Unknown Facility
Liège, Belgium
Unknown Facility
Victoria, British Columbia, Canada
Unknown Facility
Kitchener, Ontario, Canada
Unknown Facility
Olomouc, Czechia
Unknown Facility
Garches, France
Unknown Facility
Marseille, France
Unknown Facility
Warsaw, Poland
Unknown Facility
Porto, Portugal
Unknown Facility
Saint Petersburg, Russia
Related Publications (1)
Tullman M, Chartier-Kastler E, Kohan A, Keppenne V, Brucker BM, Egerdie B, Mandle M, Nicandro JP, Jenkins B, Denys P. Low-dose onabotulinumtoxinA improves urinary symptoms in noncatheterizing patients with MS. Neurology. 2018 Aug 14;91(7):e657-e665. doi: 10.1212/WNL.0000000000005991. Epub 2018 Jul 20.
PMID: 30030330BACKGROUND
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
May 15, 2012
First Posted
May 17, 2012
Study Start
June 13, 2012
Primary Completion
April 4, 2014
Study Completion
March 27, 2015
Last Updated
April 30, 2019
Results First Posted
March 22, 2016
Record last verified: 2019-04