CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 144 enrolled
Drug / intervention
OnabotulinumtoxinA +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01600716
NCT01600716Phase 3Completed
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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)

Allergan·interventional·Posted May 17, 2012·Updated Apr 30, 2019

In Brief

A Phase 3 clinical trial evaluating OnabotulinumtoxinA and Placebo (Normal Saline) for Urinary Incontinence and 2 related conditions. Completed, enrolled 144 participants across 10 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Incontinence, Multiple Sclerosis, Neurogenic Bladder
CountriesBelgium, Canada, Czechia, France, Poland, Portugal, Russia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 17, 2012
Enrollment StartJun 13, 2012
Primary CompletionApr 4, 2014
Study CompletionMar 27, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.1 years ago

Interventions

OnabotulinumtoxinAbiological

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)drug

Placebo (normal saline) is administered into the detrusor at Day 1.