Clinical trial NCT01251367: Dysport® Adult Lower Limb Spasticity Follow-on Study
Official title: A Phase III, Prospective, Multicentre, Open Label, Extension Study, to Assess the Long Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Lower Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-stroke Spasticity
Spasticity Post-Traumatic Brain Injury
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2010-12-01
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.


Eligibility criteria: Inclusion Criteria:

* Completion of Dysport® Adult Lower Limb Spasticity Double Blind study Y-55-52120-140 (NCT01249404)

Exclusion Criteria:

* Fixed contractures in lower limb

Primary outcomes:
measure: Assessment of the Long-Term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to EOS (maximum duration of 52 weeks).
measure: Mean Change From Baseline to Week 4 in Systolic and Diastolic Blood Pressure (BP)
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Heart Rate (HR)
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Red Blood Cell (RBC) Count
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Haematocrit
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Mean Corpuscular Haemoglobin (MCH)
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Mean Corpuscular Volume (MCV)
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Alkaline Phosphatase (ALP), Gamma Glutamyl Transferase (GGT), Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Total Bilirubin and Creatinine
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose
timeFrame: Baseline and Week 4 of each cycle
measure: Presence of Botulinum Toxin Type A (BTX-A) Neutralising Putative Antibodies (NAbs) Following Injection of Dysport®
timeFrame: At Week 4
measure: Mean Change From Baseline to Week 4 in 12-Lead Electrocardiogram (ECG)
timeFrame: Baseline and Week 4 of each cycle
Secondary outcomes:
measure: Mean Change From Baseline to Week 4 in the Modified Ashworth Scale (MAS) Score Measured in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in the MAS Measured in the Soleus Muscle (Knee Flexed)
timeFrame: Baseline and Week 4 of each cycle
measure: Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the GSC (Knee Extended) at Week 4
timeFrame: Week 4 of each cycle
measure: Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the Soleus Muscle (Knee Flexed) at Week 4
timeFrame: Week 4 of each cycle
measure: Physician's Global Assessment (PGA) of Treatment Response at Week 4
timeFrame: Week 4 of each cycle
measure: Percentage of Subjects With a Score of at Least +1 on the PGA Scale at Week 4
timeFrame: Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in the Range of Active Ankle Dorsiflexion Both With the Knee Flexed and With the Knee Extended
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Lower Limb Pain
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Short Form (36) Health Survey (SF-36) Quality of Life (QoL)
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline in European Quality of Life - 5 Dimensions, 5 Level (EQ-5D-5L) QoL
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Walking Speed (WS)
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Step Length
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Cadence
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X) in the GSC (Knee Extended)
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the GSC (Knee Extended)
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X) in the Soleus Muscle (Knee Flexed)
timeFrame: Baseline and Week 4 of each cycle
measure: Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the Soleus Muscle (Knee Flexed)
timeFrame: Baseline and Week 4 of each cycle
measure: Use of Walking Aids/Orthoses at Baseline and Week 4
timeFrame: Baseline and Week 4 of each cycle
Other outcomes:
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 Neurologist of Southern CT, PC
state: Connecticut
city: Miami
country: United States
facility: Design Neuroscience Center
state: Florida
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Plainview
country: United States
facility: Island Neurological Associates
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: Moss Rehab & 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 Dalla
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: University of Texas - Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Kogarah
country: Australia
facility: St George Hospital
city: Melbourne
country: Australia
facility: Epworth Rehabilitation
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
city: Melbourne
country: Australia
facility: St Vincent's Hospital
city: Sydney
country: Australia
facility: St Vincent's Hospital
city: Sydney
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: Praha 2
country: Czechia
facility: Charles University in Prague
city: Besançon
country: France
facility: CHU Jean MINJOZ
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: Nice
country: France
facility: Hôpital de L'Archet I
city: Reims
country: France
facility: Hôpital Sébastopol
city: Strasbourg
country: France
facility: Hôpital Civil
city: Toulouse
country: France
facility: Hopital Rangueil
city: Budapest
country: Hungary
facility: National Institute for Medical Rehabilitation
city: Budapest
country: Hungary
facility: Uno Medical Trials
city: Gyor
country: Hungary
facility: Petz Aladar Country Hospital
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria "Policlinico Vittorio Emanuele"
city: Katowice
country: Poland
facility: Specjalistyczna Praktyka Lekarska
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: Krakowska Akademia Neurologii Sp. z o.o.
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne
city: Poznan
country: Poland
facility: Nzoz Neuro - Card
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny
city: Alcabideche
country: Portugal
facility: Serviço de Reabilitação
city: Lisbon
country: Portugal
facility: Centro Hospitalar Lisboa Norte
city: Porto
country: Portugal
facility: Centro Hospitalar São João
city: Moscow
country: Russian Federation
facility: Medical Rehabilitation Center
city: Moscow
country: Russian Federation
facility: Scientific Research Institute of Neurology
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: 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: McAllister PJ, Khatkova SE, Faux SG, Picaut P, Raymond R, Gracies JM. Effects on walking of simultaneous upper/lower limb abobotulinumtoxina injections in patients with stroke or brain injury with spastic hemiparesis. J Rehabil Med. 2019 Oct 29;51(10):813-816. doi: 10.2340/16501977-2604.
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.