Overview

This trial is active, not recruiting.

Conditions urinary incontinence, multiple sclerosis
Treatments onabotulinumtoxina, placebo (normal saline)
Phase phase 3
Sponsor Allergan
Start date June 2012
End date April 2014
Trial size 185 participants
Trial identifier NCT01600716, 191622-117

Summary

This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) in urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
OnabotulinumtoxinA 100 U will be administered into the detrusor at Day 1. A second treatment, if applicable, will be administered at the earliest 12 weeks after the first treatment.
onabotulinumtoxina BOTOX®
OnabotulinumtoxinA 100 U will be administered into the detrusor at Day 1, followed by a second treatment, if applicable, administered at the earliest 12 weeks after the first treatment. OR, if treated with Placebo on Day 1, onabotulinumtoxinA 100 U will be administered, if applicable, at the earliest 12 weeks after treatment with placebo (normal saline).
(Other)
Placebo (normal saline) will be administered into the detrusor at Day 1. If applicable, onabotulinumtoxinA 100 U will be administered at the earliest 12 weeks after treatment with placebo (normal saline).
onabotulinumtoxina BOTOX®
OnabotulinumtoxinA 100 U will be administered into the detrusor at Day 1, followed by a second treatment, if applicable, administered at the earliest 12 weeks after the first treatment. OR, if treated with Placebo on Day 1, onabotulinumtoxinA 100 U will be administered, if applicable, at the earliest 12 weeks after treatment with placebo (normal saline).
placebo (normal saline)
Placebo (normal saline) will be administered into the detrusor at Day 1.

Primary Outcomes

Measure
Number of Urinary Incontinence Episodes
time frame: Week 6

Secondary Outcomes

Measure
Maximum Cystometric Capacity (MCC)
time frame: Week 6
Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)
time frame: Week 6
Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
time frame: Week 6

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - At least 3 episodes of urinary incontinence over a 3-day period - History of Multiple Sclerosis (MS) - Urinary incontinence not adequately controlled by anticholinergic medication Exclusion Criteria: - Current use of intermittent catheter or indwelling catheter to manage urinary incontinence - Previous or current botulinum toxin therapy of any serotype for any urological condition - Previous or current botulinum toxin therapy of any serotype for any non-urological condition within the last 12 weeks - Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral Sclerosis

Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Allergan.