Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
243 participants
INTERVENTIONAL
2011-08-31
2013-09-30
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
TRIPLE
Study Groups
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Dysport 500 U
Botulinum toxin type A
500 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Dysport 1000 U
Botulinum toxin type A
1000 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Placebo
Placebo
I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Interventions
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Botulinum toxin type A
500 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Botulinum toxin type A
1000 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Placebo
I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Modified Ashworth Scale ≥ 2
* Ambulatory patients
Exclusion Criteria
* Physiotherapy initiated less than 4 weeks before inclusion
* Previous surgery, alcohol, phenol in upper limb
* Neurological/neuromuscular disorders which may interfere with protocol evaluations
18 Years
80 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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Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
Associated Neurologist of Southern CT, PT
Fairfield, Connecticut, United States
Parkinson's Disease & Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Design Neuroscience Miami
South Miami, Florida, United States
The Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Mount Sinai School of Medicine
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Univ of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest Medical Center
Winston-Salem, North Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Texas
Dallas, Texas, United States
Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of North Texas HSC
Fort Worth, Texas, United States
University of Texas
Houston, Texas, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
Université catholique de Louvain av Hippocrate 10
Brussels, , Belgium
Clinique Universitaire
Yvoir, , Belgium
Neurologicka klinika, Olomouc
Olomouc, , Czechia
Charles University in Prague
Prague, , Czechia
CHU Jean MINJOZ
Besançon, , France
CHU Brest
Brest, , France
Centre de Réadaptation de Coubert
Coubert, , France
Centre Hospitalier Albert Chenevier-Hopital Henri Mondor
Créteil, , France
Hopital Raymond Poincarré
Garches, , France
Hôpital Sébastopol
Reims, , France
CHU Strasbourg
Strasbourg, , France
Hopital Rangueil
Toulouse, , France
National Institut for Medical Rehabilitation
Budapest, , Hungary
Petz Aladar County Hospital
Győr, , Hungary
University of Szeged
Szeged, , Hungary
Azienda Hospedaliero
Catania, , Italy
Policlinico Universitario Agostino Gemelli
Roma, , Italy
Malopolskie Centrum Medyczne
Krakow, , Poland
Krakowska Akademia Neurologii
Warsaw, , Poland
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, , Poland
Medical Rehabilitation Center
Moscow, , Russia
Scientific Center of Neurology of RAMS
Moscow, , Russia
State University
Saint Petersburg, , Russia
Derer's Hospital
Bratislava, , Slovakia
Univerzitna nemocnica Bratislava
Bratislava, , Slovakia
Countries
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References
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Delafont B, Carroll K, Vilain C, Pham E. Investigation of mixed model repeated measures analyses and non-linear random coefficient models in the context of long-term efficacy data. Pharm Stat. 2018 Sep;17(5):515-526. doi: 10.1002/pst.1868. Epub 2018 May 20.
O'Dell MW, Brashear A, Jech R, Lejeune T, Marque P, Bensmail D, Ayyoub Z, Simpson DM, Volteau M, Vilain C, Picaut P, Gracies JM. Dose-Dependent Effects of AbobotulinumtoxinA (Dysport) on Spasticity and Active Movements in Adults With Upper Limb Spasticity: Secondary Analysis of a Phase 3 Study. PM R. 2018 Jan;10(1):1-10. doi: 10.1016/j.pmrj.2017.06.008. Epub 2017 Jun 19.
Marciniak C, McAllister P, Walker H, Brashear A, Edgley S, Deltombe T, Khatkova S, Banach M, Gul F, Vilain C, Picaut P, Grandoulier AS, Gracies JM; International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group. Efficacy and Safety of AbobotulinumtoxinA (Dysport) for the Treatment of Hemiparesis in Adults With Upper Limb Spasticity Previously Treated With Botulinum Toxin: Subanalysis From a Phase 3 Randomized Controlled Trial. PM R. 2017 Dec;9(12):1181-1190. doi: 10.1016/j.pmrj.2017.06.007. Epub 2017 Jun 16.
Gracies JM, Brashear A, Jech R, McAllister P, Banach M, Valkovic P, Walker H, Marciniak C, Deltombe T, Skoromets A, Khatkova S, Edgley S, Gul F, Catus F, De Fer BB, Vilain C, Picaut P; International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group. Safety and efficacy of abobotulinumtoxinA for hemiparesis in adults with upper limb spasticity after stroke or traumatic brain injury: a double-blind randomised controlled trial. Lancet Neurol. 2015 Oct;14(10):992-1001. doi: 10.1016/S1474-4422(15)00216-1. Epub 2015 Aug 26.
Other Identifiers
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2010-019069-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Y-52-52120-145
Identifier Type: -
Identifier Source: org_study_id
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