At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 47 enrolled
Drug / intervention
Botulinum toxin type A +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 2 clinical trial evaluating Botulinum toxin type A and Placebo for Detrusor Muscle Hyperactivity. Completed, enrolled 47 participants across 17 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDetrusor Muscle Hyperactivity
CountriesCzechia, France, Germany, Italy, Poland
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedMay 2011
Primary CompletionMar 2013
TodayJul 2026
First PostedMay 23, 2011
Enrollment StartMay 1, 2011
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.1 years ago
Interventions
Botulinum toxin type Abiological
750 U intra detrusor injection on Day 1 (single dose)
Placebodrug
Intra detrusor injection on Day 1 (single dose)