At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 95 enrolled
Drug / intervention
OnabotulinumtoxinAbiological
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.
Long-term Extension Study of BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age
In Brief
A Phase 3 clinical trial evaluating OnabotulinumtoxinA for Urinary Incontinence. Completed, enrolled 95 participants across 30 sites in 8 countries.
Detailed Summary
This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA (botulinum toxin Type A; BOTOX®) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in participants who successfully completed Study 191622-120 (NCT01852045).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Incontinence
CountriesBelgium, Canada, Czechia, France, Italy, Poland, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartJan 2014
Primary CompletionNov 2018
Study CompletionOct 2019
TodayJul 2026
First PostedMay 13, 2013
Enrollment StartJan 11, 2014
Primary CompletionNov 22, 2018
Study CompletionOct 3, 2019
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 13.1 years ago
Interventions
OnabotulinumtoxinAbiological
OnabotulinumtoxinA injected into the detrusor wall. Treatments were administered as needed with a minimum of a 12-week interval between doses.