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Long-term Extension of BOTOX for Pediatric Neurogenic Detrusor Overactivity
NCT01852058Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2014
- Primary completion
- Nov 2018
- Countries
- 8
- Sponsor
- Allergan
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- onabotulinumtoxinA
- Conditions
- neurogenic detrusor overactivity (NDO)
01
Overview
Phase 3, double-blind trial of onabotulinumtoxinA in neurogenic detrusor overactivity (NDO) (3 arms), sponsored by Allergan. Primary endpoints: Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1 at Week 6, Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 2 at Week 6 and 1 more. Started Jan 2014; status: completed.
02
Design
3 arms- Study design
- Non-randomizedDouble-blind
OnabotulinumtoxinA 50 U
Intramuscular injection into detrusor wall.
OnabotulinumtoxinA 100 U
Intramuscular injection into detrusor wall.
OnabotulinumtoxinA 200 U
Intramuscular injection into detrusor wall.
03
Who it enrols
Patients 5-17 years old who successfully completed Study 191622-120, using clean intermittent catheterization. Excludes patients with Myasthenia gravis, ALS, or using baclofen pumps/indwelling catheters.
04
Endpoints
Primary
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 2
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 3
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (STEAEs)
Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes
Change From Baseline in Average Urine Volume at First Morning Catheterization
Percentage of Participants With Night Time Urinary Incontinence
Average Time to Participant's Request for Retreatment
Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS)
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