Clinical trial NCT01249404: Dysport® Adult Lower Limb Spasticity Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leg Spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2010-11-29
Enrollment: 388
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 lower limb spasticity due to stroke or traumatic brain injury.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Physician's Global Assesment (PGA) of Treatment Response at Week 4
timeFrame: At Week 4
measure: Least Squares Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed
timeFrame: Baseline and Week 4
Other outcomes:
measure: Least Squares Mean Change From Baseline in MAS Score in the GSC (Knee Extended) at Weeks 1 and 12
timeFrame: Baseline and Weeks 1 and 12
measure: Least Squares Mean Change From Baseline in MAS Score in the Soleus (Knee Flexed) at Weeks 1, 4 and 12
timeFrame: Baseline and Weeks 1, 4 and 12
measure: PGA of Treatment Response at Week 12
timeFrame: At Week 12
measure: Least Squares Mean Change From Baseline in Comfortable Barefoot Walking Speed at Weeks 1 and 12
timeFrame: Baseline and Weeks 1 and 12
measure: Least Squares Mean Change From Baseline in Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12
timeFrame: Baseline and Weeks 1, 4 and 12
measure: Least Squares Mean Change From Baseline in Maximal Barefoot Walking Speed at Weeks 1, 4 and 12
timeFrame: Baseline and Weeks 1, 4 and 12
measure: Least Squares Mean Change From Baseline in Maximal Walking Speed With Shoes at Weeks 1, 4 and 12
timeFrame: Baseline and Weeks 1, 4 and 12
measure: Least Squares Mean Change From Baseline in Cadence With Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12
timeFrame: Baseline and Weeks 1, 4 and 12
measure: Least Squares Mean Change From Baseline in Average Step Length With Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12
timeFrame: Baseline and Weeks 1, 4 and 12
measure: Least Squares Mean Change From Baseline in Cadence With Comfortable Barefoot Walking Speed at Weeks 1, 4 and 12
timeFrame: Baseline and Weeks 1, 4 and 12
measure: Least Squares Mean Change From Baseline in Average Step Length With Comfortable Barefoot Walking Speed at Weeks 1, 4 and 12
timeFrame: Baseline and Weeks 1, 4 and 12
measure: Least Squares Mean Change From Baseline in Cadence With Maximal Walking Speed With Shoes at Weeks 1, 4 and 12
timeFrame: Baseline and Weeks 1, 4 and 12
measure: Least Squares Mean Change From Baseline in Average Step Length With Maximal Walking Speed With Shoes at Weeks 1, 4 and 12
timeFrame: Baseline and Weeks 1, 4 and 12
measure: Least Squares Mean Change From Baseline in Cadence With Maximal Barefoot Walking Speed at Weeks 1, 4 and 12
timeFrame: Baseline and Weeks 1, 4 and 12
measure: Least Squares Mean Change From Baseline in Average Step Length With Maximal Barefoot Walking Speed at Weeks 1, 4 and 12
timeFrame: Baseline and Weeks 1, 4 and 12
measure: Least Squares Mean Change From Baseline in the Tardieu Scale in the GSC (Knee Extended) at Weeks 1, 4 and 12: Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X)
timeFrame: Baseline and Weeks 1, 4 and 12
measure: Least Squares Mean Change From Baseline in the Tardieu Scale in the GSC (Knee Extended) at Weeks 1, 4 and 12: Spasticity Grade (Y)
timeFrame: Baseline and Weeks 1, 4 and 12
measure: Least Squares Mean Change From Baseline in the Tardieu Scale in the Soleus (Knee Flexed) at Weeks 1, 4 and 12: Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X)
timeFrame: Baseline and Weeks 1, 4 and 12
measure: Least Squares Mean Change From Baseline in the Tardieu Scale in the Soleus (Knee Flexed) at Weeks 1, 4 and 12: Spasticity Grade (Y)
timeFrame: Baseline and Weeks 1, 4 and 12
measure: Least Squares Mean Change From Baseline in the Range of Active Dorsiflexion at Weeks 1, 4 and 12 (Knee Extended and Flexed)
timeFrame: Baseline and Weeks 1, 4 and 12
measure: Least Squares Mean Change From Baseline in Lower Limb Pain at Weeks 1, 4 and 12
timeFrame: Baseline and Weeks 1, 4 and 12
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Downey
country: United States
facility: Rancho Los Amigos
state: California
city: Oxnard
country: United States
facility: Pacific Neuroscience Medical Group
state: California
city: Fairfield
country: United States
facility: Associated Neurologists of Southern CT, PC
state: Connecticut
city: Boca Raton
country: United States
facility: Parkinson's Disease & Movement Disorders Center of Boca Raton
state: Florida
city: Miami Gardens
country: United States
facility: Design Neuroscience
state: Florida
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: University of North Carolina - Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Elkins Park
country: United States
facility: MossRehab & Albert Einstein
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Fort Worth
country: United States
facility: University of North Texas HSC at Ben Hogan Center
state: Texas
city: Houston
country: United States
facility: Neurorehabilitation Specialist
state: Texas
city: Houston
country: United States
facility: University of Texas - Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Richmond
country: Australia
facility: Epworth HealthCare
state: Victoria
city: Caulfield
country: Australia
facility: Caulfield Hospital
city: Darlinghurst
country: Australia
facility: Saint Vincent's Hospital
city: Fitzroy
country: Australia
facility: Saint Vincent's Hospital
city: Kogarah
country: Australia
facility: St George Hospital
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: Richmond
country: Australia
facility: Epworth Healthcare
city: Westmead
country: Australia
facility: Westmead Hospital
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
city: Praha
country: Czechia
facility: Neurologicka Klinika, VFN
city: Besançon
country: France
facility: CHU Jean MINJOZ
city: Brest
country: France
facility: Service de Réeducation Fonctionnelle, CHU de Brest, Hôpital Morvan
city: Coubert
country: France
facility: Centre de Réadaptation de Coubert
city: Créteil
country: France
facility: Centre Hospitalier Albert Chenevier
city: Garches
country: France
facility: Hopital Raymond Poincarré
city: Nice
country: France
facility: Hôpital de L'Archet
city: Reims
country: France
facility: Hôpital Sébastopol, Médecine Physique et Réadaptation, CHU Reims
city: Reims
country: France
facility: Hôpital Sébastopol
city: Strasbourg
country: France
facility: Nouvel Civil Hospital
city: Toulouse
country: France
facility: Hopital Rangueil
city: Budapest
country: Hungary
facility: National Institute for Medical Rehabilitation
city: Budapest
country: Hungary
facility: Szent János Hospital
city: Budapest
country: Hungary
facility: Uno Medical Trials
city: Gyor
country: Hungary
facility: Petz Aladar Country Hospital
city: Kisbér
country: Hungary
facility: Batthyány Kázmér Hospital
city: Catania
country: Italy
facility: Azienda Ospedaliero
city: Fossano
country: Italy
facility: SSD Neurofisiologia Riabilitativa
city: Milano
country: Italy
facility: Servizio di Neurofisiologia Clinica-Ospedale San Raffaele
city: Treviso
country: Italy
facility: Polo IRCCS Eugenio Medea La Nostra Famiglia
city: Katowice
country: Poland
facility: Specjalistyczna Praktyka Lekarska
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: Krakowska Akademia Neurologii
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne
city: Poznan
country: Poland
facility: Nzoz Neuro - Card
city: Warsaw
country: Poland
facility: Samodzielny Publiczny Centralny Szpital
city: Alcabideche
country: Portugal
facility: Servicio de Rehabilitation de Adultos
city: Lisbon
country: Portugal
facility: Centro Hospitalar Lisboa Norte
city: Porto
country: Portugal
facility: Centro Hospitalar São João
city: Moscow
country: Russian Federation
facility: Treatments and Rehabilitation Center
city: Saint Petersburg
country: Russian Federation
facility: State Institution "Scientific Centre of Neurology of Russian Academy of Medical Sciences"
city: St Petersburg
country: Russian Federation
facility: St-Petersberg State Medical University
city: Bratislava
country: Slovakia
facility: Neurologicka klinika, Univerzitna nemocnica Bratislava
city: Bratislava
country: Slovakia
facility: Univerzitna Nemocnica Bratislava
Study officials:
affiliation: Ipsen
name: Ipsen Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.