Dysport® Adult Upper Limb Spasticity
A Phase III, Multicentre, Prospective, Double Blind, Randomised, Placebo Controlled Study, Assessing the Efficacy and Safety of Dysport® Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury
2 other identifiers
interventional
243
9 countries
40
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 upper 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 Aug 2011
40 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
March 10, 2011
CompletedFirst Posted
Study publicly available on registry
March 11, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
October 23, 2015
CompletedSeptember 28, 2022
September 1, 2022
2.1 years
March 10, 2011
August 11, 2015
September 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG)
MAS scale is used to assess muscle tone using a 6-point scale where: 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) when the part is flexed or extended, 1±Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the ROM, 2=Marked increase in muscle tone through most of the ROM but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part(s) rigid in flexion or extension. The MAS has been derived for analyses as follows: 0=0 ; 1=1; 1+=2; 2=3; 3=4 and 4=5.
From Baseline (Day 1) to Week 4
Secondary Outcomes (2)
Physician's Global Assessment (PGA) of Treatment Response
At Week 4
Change From Baseline in DAS Score for the Principal Target of Treatment (PTT)
From Baseline (Day 1) to Week 4
Study Arms (3)
Dysport 500 U
EXPERIMENTALDysport 1000 U
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
500 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Eligibility Criteria
You may qualify if:
- Adult patients - post stroke or brain injury
- Modified Ashworth Scale ≥ 2
- Ambulatory patients
You may not qualify if:
- Previous treatment with botulinum toxin of any type within 4 months prior to study entry for any condition
- Previous surgery, alcohol, phenol in upper limb
- Neurological/neuromuscular disorders which may interfere with protocol evaluations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (40)
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242, United States
Associated Neurologist of Southern CT, PT
Fairfield, Connecticut, 06824, United States
Parkinson's Disease & Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33488, United States
Design Neuroscience Miami
South Miami, Florida, 33169, United States
The Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
Mount Sinai School of Medicine
New York, New York, 10029-6574, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Univ of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Wake Forest Medical Center
Winston-Salem, North Carolina, 27157, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
University of Texas
Dallas, Texas, 75080, United States
Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
University of North Texas HSC
Fort Worth, Texas, 76104, United States
University of Texas
Houston, Texas, 77030, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132, 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
Related Publications (4)
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.
PMID: 29781237DERIVEDO'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.
PMID: 28634000DERIVEDMarciniak 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.
PMID: 28625615DERIVEDGracies 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.
PMID: 26318836DERIVED
MeSH Terms
Conditions
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
March 10, 2011
First Posted
March 11, 2011
Study Start
August 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
September 28, 2022
Results First Posted
October 23, 2015
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.