Trials / Completed

CompletedNCT01852058

A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity

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

Status: Completed
Phase: Phase 3
Study type: Interventional
Enrollment: 95 (actual)

Sponsor: Allergan · Industry
Sex: All
Age: 5 Years – 17 Years
Healthy volunteers: Not accepted

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).

Conditions

Urinary Incontinence

Interventions

Type	Name	Description
BIOLOGICAL	OnabotulinumtoxinA	OnabotulinumtoxinA injected into the detrusor wall. Treatments were administered as needed with a minimum of a 12-week interval between doses.

Timeline

Start date: 2014-01-11
Primary completion: 2018-11-22
Completion: 2019-10-03
First posted: 2013-05-13
Last updated: 2020-05-12
Results posted: 2020-05-12

Locations

30 sites across 8 countries: United States, Belgium, Canada, Czechia, France, Italy, Poland, Turkey (Türkiye)

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT01852058. Inclusion in this directory is not an endorsement.