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.
2 other identifiers
interventional
47
5 countries
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2011
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 17, 2011
CompletedFirst Posted
Study publicly available on registry
May 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
September 1, 2014
CompletedSeptember 27, 2022
September 1, 2022
1.8 years
May 17, 2011
March 27, 2014
September 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Daily Incontinence Episode Frequency (IEF)
Baseline and Day 84
Secondary Outcomes (8)
Urodynamics: Maximum Cystometric Capacity
Baseline, Days 14, 42 and 84
Urodynamics:Maximum Detrusor Pressure
Baseline, Days 14, 42 and 84
Physician's Global Assessment Score of Treatment Response
Day 14
Physician's Global Assessment Score of Treatment Response
Day 42
Physician's Global Assessment Score of Treatment Response
Day 84
- +3 more secondary outcomes
Study Arms (4)
Dysport 750 U (15 injection sites)
EXPERIMENTALPlacebo (15 injection sites)
PLACEBO COMPARATORDysport 750 U (30 injection sites)
EXPERIMENTALPlacebo (30 injection sites)
PLACEBO COMPARATORInterventions
750 U intra detrusor injection on Day 1 (single dose)
Intra detrusor injection on Day 1 (single dose)
Eligibility Criteria
You may qualify if:
- Subject, family member or care giver was willing and able to perform clean intermittent catheterisation (CIC) for the duration of the study
- Inadequate response or refractory to anticholinergic medication
- Botulinum Toxin naive for intradetrusor injections and with no previous treatment with Botulinum Toxin of any type, within 3 months prior to study entry for any other condition
- Have a minimum of 2 incontinences per day calculated as the average daily incontinence episode frequency (IEF) over the 3 days preceding the baseline visit
You may not qualify if:
- Significant Baseline renal and/or urinary tract pathology
- Previous treatment with any endovesical pharmacology agent including detrusor Botulinum Toxin injection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (17)
Faculty Hospital Motol
Prague, Czechia
THOMAYER Faculty Hospital
Prague, Czechia
Hopital Raymond Poincaré
Garches, France
Hopital HURIET
Lille, France
Hôpital Lyon Sud -Hospices Civils de Lyon
Lyon, France
Hopital de la conception
Marseille, France
CHU Hotel Dieu
Nantes, France
Groupe Hospitalier La Pitié Salpetriere
Paris, France
Hopital Tenon
Paris, France
CMRRF Kerpape
Ploemeur, France
CHU Rouen - Hopital Charles Nicolle
Rouen, France
Nouvel Hopital civil de Strasbourg
Strasbourg, France
CHU Toulouse - Hopital Rangueil
Toulouse, France
Universitätsklinik Kiel
Kiel, Germany
Städtisches Klinikum Neunkirchen
Neunkirchen, Germany
Ospedale Careggi
Florence, Italy
NZOZ Centrum Medyczne Mazovia
Warsaw, Poland
Related Publications (1)
Denys P, Del Popolo G, Amarenco G, Karsenty G, Le Berre P, Padrazzi B, Picaut P; Dysport Study Group. Efficacy and safety of two administration modes of an intra-detrusor injection of 750 units dysport(R) (abobotulinumtoxinA) in patients suffering from refractory neurogenic detrusor overactivity (NDO): A randomised placebo-controlled phase IIa study. Neurourol Urodyn. 2017 Feb;36(2):457-462. doi: 10.1002/nau.22954. Epub 2016 Jan 12.
PMID: 26756554BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director Neurology
- Organization
- Ipsen
Study Officials
- STUDY DIRECTOR
Ipsen Study Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2011
First Posted
May 23, 2011
Study Start
May 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
September 27, 2022
Results First Posted
September 1, 2014
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.