NCT01357980

Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis

A Phase IIa, Multicentre, Double Blind, Single Dose, Parallel Group, Placebo Controlled, Clinical Pilot Study to Assess the Efficacy and Safety of a Single Dose, Intra-Detrusor Injections of 750 Units of Dysport® in Subjects Suffering From Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of a single dose of 750 U of Dysport compared to placebo for the improvement in the daily incontinence episode frequency for each administration mode in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.

Conditions

• Detrusor Muscle Hyperactivity

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum toxin type A	750 U intra detrusor injection on Day 1 (single dose)
DRUG	Placebo	Intra detrusor injection on Day 1 (single dose)

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-05-23
• Last updated: 2022-09-27
• Results posted: 2014-09-01

Locations

17 sites across 5 countries: Czechia, France, Germany, Italy, Poland