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Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis

NCT01357980 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2022-09-27

Study results available
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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

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)

Sponsors & Collaborators

Principal Investigators

  • Ipsen Study Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Czechia
  • France
  • Germany
  • Italy
  • Poland

Study Locations

More Related Trials

Entities

Drugs
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 NCT01357980 on ClinicalTrials.gov