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Dysport in Neurogenic Detrusor Overactivity
NCT01357980Phase 2
Key facts
- Status
- Completed
- Start
- May 2011
- Primary completion
- Mar 2013
- Countries
- 5
- Sponsor
- Ipsen
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- abobotulinumtoxinA
- Conditions
- neurogenic detrusor overactivity (NDO)
01
Overview
Phase 2, randomised, double-blind trial of abobotulinumtoxinA in neurogenic detrusor overactivity (NDO) (4 arms), sponsored by Ipsen. Primary endpoint: Daily Incontinence Episode Frequency at Day 84. Started May 2011; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Dysport 15 sites
750 U Dysport across 15 injection sites
Placebo 15 sites
Placebo across 15 injection sites
Dysport 30 sites
750 U Dysport across 30 injection sites
Placebo 30 sites
Placebo across 30 injection sites
03
Who it enrols
Patients with neurogenic detrusor overactivity due to SCI or MS, refractory to anticholinergics, and naive to botulinum toxin.
04
Endpoints
Primary
Daily Incontinence Episode Frequency
Secondary
Maximum Cystometric Capacity
Maximum Detrusor Pressure
Physician's Global Assessment
Quality of Life Total Summary Score
Pain Visual Analogue Scale
05
Results
Not all primary endpoints met
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