Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis
NCT ID: NCT01357980
Last Updated: 2022-09-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2011-05-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dysport 750 U (15 injection sites)
Botulinum toxin type A
750 U intra detrusor injection on Day 1 (single dose)
Placebo (15 injection sites)
Placebo
Intra detrusor injection on Day 1 (single dose)
Dysport 750 U (30 injection sites)
Botulinum toxin type A
750 U intra detrusor injection on Day 1 (single dose)
Placebo (30 injection sites)
Placebo
Intra detrusor injection on Day 1 (single dose)
Interventions
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Botulinum toxin type A
750 U intra detrusor injection on Day 1 (single dose)
Placebo
Intra detrusor injection on Day 1 (single dose)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Previous treatment with any endovesical pharmacology agent including detrusor Botulinum Toxin injection
18 Years
70 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Study Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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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
Countries
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References
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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.
Other Identifiers
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2010-023210-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Y-52-52120-155
Identifier Type: -
Identifier Source: org_study_id
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