Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
352 participants
INTERVENTIONAL
2011-06-30
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dysport®
Dysport® is injected into lower limbs across 4 cycles of treatment, a minimum of 12 weeks between 2 injections. Doses vary from 1000 U to 1500 U.
Botulinum toxin type A
I.M. (intramuscular) injection on day 1 of each treatment cycle.
Interventions
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Botulinum toxin type A
I.M. (intramuscular) injection on day 1 of each treatment cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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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Mayo Clinic Arizona
Scottsdale, Arizona, United States
Rancho Los Amigos
Downey, California, United States
Pacific Neuroscience Medical Group
Oxnard, California, United States
Associated Neurologist of Southern CT, PC
Fairfield, Connecticut, United States
Design Neuroscience Center
Miami, Florida, United States
Weill Cornell Medical College
New York, New York, United States
Island Neurological Associates
Plainview, New York, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Moss Rehab & Albert Einstein
Elkins Park, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
The University of Texas Southwestern Medical Center at Dalla
Dallas, Texas, United States
University of North Texas HSC at Ben Hogan Center
Fort Worth, Texas, United States
University of Texas - Houston
Houston, Texas, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
St George Hospital
Kogarah, , Australia
Epworth Rehabilitation
Melbourne, , Australia
Royal Melbourne Hospital
Melbourne, , Australia
St Vincent's Hospital
Melbourne, , Australia
St Vincent's Hospital
Sydney, , Australia
Westmead Hospital
Sydney, , Australia
Université catholique de Louvain av Hippocrate 10
Brussels, , Belgium
Clinique Universitaire
Yvoir, , Belgium
Charles University in Prague
Prague, , Czechia
CHU Jean MINJOZ
Besançon, , France
Centre de Réadaptation de Coubert
Coubert, , France
Centre Hospitalier Albert Chenevier-Hopital Henri Mondor
Créteil, , France
Hopital Raymond Poincarré
Garches, , France
Hôpital de L'Archet I
Nice, , France
Hôpital Sébastopol
Reims, , France
Hôpital Civil
Strasbourg, , France
Hopital Rangueil
Toulouse, , France
National Institute for Medical Rehabilitation
Budapest, , Hungary
Uno Medical Trials
Budapest, , Hungary
Petz Aladar Country Hospital
Győr, , Hungary
Azienda Ospedaliero Universitaria "Policlinico Vittorio Emanuele"
Catania, , Italy
Specjalistyczna Praktyka Lekarska
Katowice, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
Krakowska Akademia Neurologii Sp. z o.o.
Krakow, , Poland
Malopolskie Centrum Medyczne
Krakow, , Poland
Nzoz Neuro - Card
Poznan, , Poland
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, , Poland
Serviço de Reabilitação
Alcabideche, , Portugal
Centro Hospitalar Lisboa Norte
Lisbon, , Portugal
Centro Hospitalar São João
Porto, , Portugal
Medical Rehabilitation Center
Moscow, , Russia
Scientific Research Institute of Neurology
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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Esquenazi A, Brashear A, Deltombe T, Rudzinska-Bar M, Krawczyk M, Skoromets A, O'Dell MW, Grandoulier AS, Vilain C, Picaut P, Gracies JM. The Effect of Repeated abobotulinumtoxinA (Dysport(R)) Injections on Walking Velocity in Persons with Spastic Hemiparesis Caused by Stroke or Traumatic Brain Injury. PM R. 2021 May;13(5):488-495. doi: 10.1002/pmrj.12459. Epub 2020 Sep 11.
Esquenazi A, Stoquart G, Hedera P, Jacinto LJ, Dimanico U, Constant-Boyer F, Brashear A, Grandoulier AS, Vilain C, Picaut P, Gracies JM. Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Hemiparesis in Adults with Lower Limb Spasticity Previously Treated With Other Botulinum Toxins: A Secondary Analysis of a Randomized Controlled Trial. PM R. 2020 Sep;12(9):853-860. doi: 10.1002/pmrj.12348. Epub 2020 Mar 27.
McAllister PJ, Khatkova SE, Faux SG, Picaut P, Raymond R, Gracies JM. Effects on walking of simultaneous upper/lower limb abobotulinumtoxina injections in patients with stroke or brain injury with spastic hemiparesis. J Rehabil Med. 2019 Oct 29;51(10):813-816. doi: 10.2340/16501977-2604.
Gracies JM, Esquenazi A, Brashear A, Banach M, Kocer S, Jech R, Khatkova S, Benetin J, Vecchio M, McAllister P, Ilkowski J, Ochudlo S, Catus F, Grandoulier AS, Vilain C, Picaut P; International AbobotulinumtoxinA Adult Lower Limb Spasticity Study Group. Efficacy and safety of abobotulinumtoxinA in spastic lower limb: Randomized trial and extension. Neurology. 2017 Nov 28;89(22):2245-2253. doi: 10.1212/WNL.0000000000004687. Epub 2017 Nov 1.
Other Identifiers
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2009-017723-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Y-55-52120-142
Identifier Type: -
Identifier Source: org_study_id
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