Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
388 participants
INTERVENTIONAL
2011-03-31
2014-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dysport® Adult Upper Limb Spasticity
NCT01313299
Dysport® Adult Lower Limb Spasticity Follow-on Study
NCT01251367
Dysport® Adult Upper Limb Spasticity Extension Study
NCT01313312
Effects on Quality of Life Following Dysport Treatment in Post-stroke Spasticity of the Arm
NCT00216411
Dysport® Pediatric Lower Limb Spasticity Study
NCT01249417
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dysport® 1000 U, IM
1000 U, I.M. (in the muscle), on day 1 (single treatment cycle)
Botulinum toxin type A
I.M. injection on day 1 (single treatment cycle)
Dysport® 1500 U, IM
1500 U, I.M., on day 1 (single treatment cycle)
Botulinum toxin type A
I.M. injection on day 1 (single treatment cycle)
Placebo
I.M., on day 1 (single treatment cycle)
Placebo
I.M. injection on day 1 (single treatment cycle)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Botulinum toxin type A
I.M. injection on day 1 (single treatment cycle)
Placebo
I.M. injection on day 1 (single treatment cycle)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Post stroke or brain injury
* Intensity of muscle tone greater than or equal to 2, as measured on the Modified Ashworth Scale
* Ambulatory patients
Exclusion Criteria
* Physiotherapy initiated less than 4 weeks before entry
* Previous surgery or previous treatment with phenol and/or alcohol in lower limb
* Neurological/neuromuscular disorders which may interfere with protocol evaluations
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ipsen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ipsen Study Director
Role: STUDY_DIRECTOR
Ipsen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Rancho Los Amigos
Downey, California, United States
Pacific Neuroscience Medical Group
Oxnard, California, United States
Associated Neurologists of Southern CT, PC
Fairfield, Connecticut, United States
Parkinson's Disease & Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Design Neuroscience
Miami Gardens, Florida, United States
Mount Sinai School of Medicine
New York, New York, United States
Weill Cornell Medical College
New York, 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
MossRehab & Albert Einstein
Elkins Park, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of North Texas HSC at Ben Hogan Center
Fort Worth, Texas, United States
Neurorehabilitation Specialist
Houston, Texas, United States
University of Texas - Houston
Houston, Texas, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
Epworth HealthCare
Richmond, Victoria, Australia
Caulfield Hospital
Caulfield, , Australia
Saint Vincent's Hospital
Darlinghurst, , Australia
Saint Vincent's Hospital
Fitzroy, , Australia
St George Hospital
Kogarah, , Australia
Royal Melbourne Hospital
Parkville, , Australia
Epworth Healthcare
Richmond, , Australia
Westmead Hospital
Westmead, , Australia
Université catholique de Louvain av Hippocrate 10
Brussels, , Belgium
Clinique Universitaire
Yvoir, , Belgium
Neurologicka Klinika
Olomouc, , Czechia
Neurologicka Klinika, VFN
Prague, , Czechia
CHU Jean MINJOZ
Besançon, , France
Service de Réeducation Fonctionnelle, CHU de Brest, Hôpital Morvan
Brest, , France
Centre de Réadaptation de Coubert
Coubert, , France
Centre Hospitalier Albert Chenevier
Créteil, , France
Hopital Raymond Poincarré
Garches, , France
Hôpital de L'Archet
Nice, , France
Hôpital Sébastopol, Médecine Physique et Réadaptation, CHU Reims
Reims, , France
Hôpital Sébastopol
Reims, , France
Nouvel Civil Hospital
Strasbourg, , France
Hopital Rangueil
Toulouse, , France
National Institute for Medical Rehabilitation
Budapest, , Hungary
Szent János Hospital
Budapest, , Hungary
Uno Medical Trials
Budapest, , Hungary
Petz Aladar Country Hospital
Győr, , Hungary
Batthyány Kázmér Hospital
Kisbér, , Hungary
Azienda Ospedaliero
Catania, , Italy
SSD Neurofisiologia Riabilitativa
Fossano, , Italy
Servizio di Neurofisiologia Clinica-Ospedale San Raffaele
Milan, , Italy
Polo IRCCS Eugenio Medea La Nostra Famiglia
Treviso, , Italy
Specjalistyczna Praktyka Lekarska
Katowice, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
Krakowska Akademia Neurologii
Krakow, , Poland
Malopolskie Centrum Medyczne
Krakow, , Poland
Nzoz Neuro - Card
Poznan, , Poland
Samodzielny Publiczny Centralny Szpital
Warsaw, , Poland
Servicio de Rehabilitation de Adultos
Alcabideche, , Portugal
Centro Hospitalar Lisboa Norte
Lisbon, , Portugal
Centro Hospitalar São João
Porto, , Portugal
Treatments and Rehabilitation Center
Moscow, , Russia
State Institution "Scientific Centre of Neurology of Russian Academy of Medical Sciences"
Saint Petersburg, , Russia
St-Petersberg State Medical University
Saint Petersburg, , Russia
Neurologicka klinika, Univerzitna nemocnica Bratislava
Bratislava, , Slovakia
Univerzitna Nemocnica Bratislava
Bratislava, , Slovakia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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
Review additional registry numbers or institutional identifiers associated with this trial.
2009-015868-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Y-55-52120-140
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.