Clinical trial NCT01313299: Dysport® Adult Upper Limb Spasticity
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nervous System Disorders
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2011-03-11
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Adult patients - post stroke or brain injury
* Modified Ashworth Scale ≥ 2
* Ambulatory patients

Exclusion Criteria:

* Previous treatment with botulinum toxin of any type within 4 months prior to study entry for any condition
* Physiotherapy initiated less than 4 weeks before inclusion
* Previous surgery, alcohol, phenol in upper limb
* Neurological/neuromuscular disorders which may interfere with protocol evaluations

Primary outcomes:
measure: Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG)
timeFrame: From Baseline (Day 1) to Week 4
Secondary outcomes:
measure: Physician's Global Assessment (PGA) of Treatment Response
timeFrame: At Week 4
measure: Change From Baseline in DAS Score for the Principal Target of Treatment (PTT)
timeFrame: From Baseline (Day 1) to Week 4
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
city: Fairfield
country: United States
facility: Associated Neurologist of Southern CT, PT
state: Connecticut
city: Boca Raton
country: United States
facility: Parkinson's Disease & Movement Disorders Center of Boca Raton
state: Florida
city: South Miami
country: United States
facility: Design Neuroscience Miami
state: Florida
city: Chicago
country: United States
facility: The Rehabilitation Institute of Chicago
state: Illinois
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Chapel Hill
country: United States
facility: Univ of North Carolina - Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: University of Texas
state: Texas
city: Dallas
country: United States
facility: Southwestern Medical Center at Dallas
state: Texas
city: Fort Worth
country: United States
facility: University of North Texas HSC
state: Texas
city: Houston
country: United States
facility: University of Texas
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Bruxelles
country: Belgium
facility: Université catholique de Louvain av Hippocrate 10
city: Yvoir
country: Belgium
facility: Clinique Universitaire
city: Olomouc
country: Czechia
facility: Neurologicka klinika, Olomouc
city: Praha 2
country: Czechia
facility: Charles University in Prague
city: Besançon
country: France
facility: CHU Jean MINJOZ
city: Brest
country: France
facility: CHU Brest
city: Coubert
country: France
facility: Centre de Réadaptation de Coubert
city: Créteil
country: France
facility: Centre Hospitalier Albert Chenevier-Hopital Henri Mondor
city: Garches
country: France
facility: Hopital Raymond Poincarré
city: Reims
country: France
facility: Hôpital Sébastopol
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: Hopital Rangueil
city: Budapest
country: Hungary
facility: National Institut for Medical Rehabilitation
city: Gyor
country: Hungary
facility: Petz Aladar County Hospital
city: Szeged
country: Hungary
facility: University of Szeged
city: Catania
country: Italy
facility: Azienda Hospedaliero
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne
city: Warszawa
country: Poland
facility: Krakowska Akademia Neurologii
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny
city: Moscow
country: Russian Federation
facility: Medical Rehabilitation Center
city: Moscow
country: Russian Federation
facility: Scientific Center of Neurology of RAMS
city: St Petersburg
country: Russian Federation
facility: State University
city: Bratislava
country: Slovakia
facility: Derer's Hospital
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava
Study officials:
affiliation: Ipsen
name: Ipsen Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.