Dysport® Adult Lower Limb Spasticity Study
A Phase III, Multicentre, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With Hemiparesis Due to Stroke or Traumatic Brain Injury
2 other identifiers
interventional
388
11 countries
62
Brief Summary
The purpose of this research study is to assess the efficacy of Dysport® compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2011
Typical duration for phase_3
62 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
First Submitted
Initial submission to the registry
November 25, 2010
CompletedFirst Posted
Study publicly available on registry
November 29, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
October 17, 2017
CompletedSeptember 28, 2022
September 1, 2022
2.8 years
November 25, 2010
July 3, 2017
September 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)
Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM)), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Week 4 is reported.
Baseline and Week 4
Secondary Outcomes (2)
Physician's Global Assesment (PGA) of Treatment Response at Week 4
At Week 4
Least Squares Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed
Baseline and Week 4
Other Outcomes (21)
Least Squares Mean Change From Baseline in MAS Score in the GSC (Knee Extended) at Weeks 1 and 12
Baseline and Weeks 1 and 12
Least Squares Mean Change From Baseline in MAS Score in the Soleus (Knee Flexed) at Weeks 1, 4 and 12
Baseline and Weeks 1, 4 and 12
PGA of Treatment Response at Week 12
At Week 12
- +18 more other outcomes
Study Arms (3)
Dysport® 1000 U, IM
EXPERIMENTAL1000 U, I.M. (in the muscle), on day 1 (single treatment cycle)
Dysport® 1500 U, IM
EXPERIMENTAL1500 U, I.M., on day 1 (single treatment cycle)
Placebo
PLACEBO COMPARATORI.M., on day 1 (single treatment cycle)
Interventions
I.M. injection on day 1 (single treatment cycle)
Eligibility Criteria
You may qualify if:
- Subjects aged 18 to 80 years of age
- Post stroke or brain injury
- Intensity of muscle tone greater than or equal to 2, as measured on the Modified Ashworth Scale
- Ambulatory patients
You may not qualify if:
- Fixed contractures
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (62)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
Rancho Los Amigos
Downey, California, 90242, United States
Pacific Neuroscience Medical Group
Oxnard, California, 93030, United States
Associated Neurologists of Southern CT, PC
Fairfield, Connecticut, 06824, United States
Parkinson's Disease & Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486, United States
Design Neuroscience
Miami Gardens, Florida, 33169, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Weill Cornell Medical College
New York, New York, 10065, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7200, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
MossRehab & Albert Einstein
Elkins Park, Pennsylvania, 19027, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390-9016, United States
University of North Texas HSC at Ben Hogan Center
Fort Worth, Texas, 76104, United States
Neurorehabilitation Specialist
Houston, Texas, 66211, United States
University of Texas - Houston
Houston, Texas, 77030, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
Epworth HealthCare
Richmond, Victoria, 3121, Australia
Caulfield Hospital
Caulfield, 3162, 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, 775 20, Czechia
Neurologicka Klinika, VFN
Prague, 12000, Czechia
CHU Jean MINJOZ
Besançon, France
Service de Réeducation Fonctionnelle, CHU de Brest, Hôpital Morvan
Brest, 29609, 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, 51092, 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, 125367, Russia
St-Petersberg State Medical University
Saint Petersburg, Russia
Neurologicka klinika, Univerzitna nemocnica Bratislava
Bratislava, 82606, Slovakia
Univerzitna Nemocnica Bratislava
Bratislava, Slovakia
Related Publications (3)
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.
PMID: 32741133DERIVEDEsquenazi 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.
PMID: 32108436DERIVEDGracies 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.
PMID: 29093068DERIVED
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 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2010
First Posted
November 29, 2010
Study Start
March 1, 2011
Primary Completion
December 1, 2013
Study Completion
May 1, 2014
Last Updated
September 28, 2022
Results First Posted
October 17, 2017
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.