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Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1

NCT02660138 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2022-09-28

Study results available
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Summary

The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® (AbobotulinumtoxinA) doses (600 units \[U\] and 800 U), compared to placebo in reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).

Conditions

Interventions

BIOLOGICAL

Botulinum toxin type A

600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points

BIOLOGICAL

Botulinum toxin type A

800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points

DRUG

Placebo

AbobotulinumtoxinA Placebo 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points

DRUG

Placebo

AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-11-09
Completion
2019-02-14
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • South Korea
  • Turkey (Türkiye)

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02660138 on ClinicalTrials.gov