A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- Botulinum toxin type a
Synaptosomal nerve-associated protein 25 (SNAP-25) hydrolytic enzyme
What it measured
Main measures
• Number of episodes of urinary incontinence as recorded in the patient bladder diary
Bladder, bowel and sexual function
Who could take part
MS (type not specified)
Inclusion: 1. Patient is male or female, aged 18 to 80 years old. Exclusion: 1. Patient has had previous or current botulinum toxin therapy of any serotype for any urological condition or treatment within 3 months of Randomization/Day 1 for any other condition
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To evaluate the safety and efficacy of 2 dose levels of BOTOX® (200 U or 300 U) compared to placebo injected into the detrusor for the treatment of urinary incontinence caused by neurogenic detrusor overactivity in patients who have not been adequately managed with anticholinergic therapy and have neurological respiratory impairment.
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History
Started
Jun 2007
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