Back to resultsDysport® Adult Lower Limb Spasticity Study
Primary Purpose
Leg Spasticity
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Botulinum toxin type A
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Leg Spasticity
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
Sites / Locations
- Mayo Clinic Arizona
- Rancho Los Amigos
- Pacific Neuroscience Medical Group
- Associated Neurologists of Southern CT, PC
- Parkinson's Disease & Movement Disorders Center of Boca Raton
- Design Neuroscience
- Mount Sinai School of Medicine
- Weill Cornell Medical College
- University of North Carolina - Chapel Hill
- Wake Forest University Baptist Medical Center
- MossRehab & Albert Einstein
- Vanderbilt University
- The University of Texas Southwestern Medical Center at Dallas
- University of North Texas HSC at Ben Hogan Center
- Neurorehabilitation Specialist
- University of Texas - Houston
- University of Utah School of Medicine
- Epworth HealthCare
- Caulfield Hospital
- Saint Vincent's Hospital
- Saint Vincent's Hospital
- St George Hospital
- Royal Melbourne Hospital
- Epworth Healthcare
- Westmead Hospital
- Université catholique de Louvain av Hippocrate 10
- Clinique Universitaire
- Neurologicka Klinika
- Neurologicka Klinika, VFN
- CHU Jean MINJOZ
- Service de Réeducation Fonctionnelle, CHU de Brest, Hôpital Morvan
- Centre de Réadaptation de Coubert
- Centre Hospitalier Albert Chenevier
- Hopital Raymond Poincarré
- Hôpital de L'Archet
- Hôpital Sébastopol, Médecine Physique et Réadaptation, CHU Reims
- Hôpital Sébastopol
- Nouvel Civil Hospital
- Hopital Rangueil
- National Institute for Medical Rehabilitation
- Szent János Hospital
- Uno Medical Trials
- Petz Aladar Country Hospital
- Batthyány Kázmér Hospital
- Azienda Ospedaliero
- SSD Neurofisiologia Riabilitativa
- Servizio di Neurofisiologia Clinica-Ospedale San Raffaele
- Polo IRCCS Eugenio Medea La Nostra Famiglia
- Specjalistyczna Praktyka Lekarska
- Centrum Medyczne Plejady
- Krakowska Akademia Neurologii
- Malopolskie Centrum Medyczne
- Nzoz Neuro - Card
- Samodzielny Publiczny Centralny Szpital
- Servicio de Rehabilitation de Adultos
- Centro Hospitalar Lisboa Norte
- Centro Hospitalar São João
- Treatments and Rehabilitation Center
- State Institution "Scientific Centre of Neurology of Russian Academy of Medical Sciences"
- St-Petersberg State Medical University
- Neurologicka klinika, Univerzitna nemocnica Bratislava
- Univerzitna Nemocnica Bratislava
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Dysport® 1000 U, IM
Dysport® 1500 U, IM
Placebo
Arm Description
1000 U, I.M. (in the muscle), on day 1 (single treatment cycle)
1500 U, I.M., on day 1 (single treatment cycle)
I.M., on day 1 (single treatment cycle)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Physician's Global Assesment (PGA) of Treatment Response at Week 4
An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA score at Week 4 is reported.
Least Squares Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed
Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Week 4 is reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01249404
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Spasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
388 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dysport® 1000 U, IM
Arm Type
Experimental
Arm Description
1000 U, I.M. (in the muscle), on day 1 (single treatment cycle)
Arm Title
Dysport® 1500 U, IM
Arm Type
Experimental
Arm Description
1500 U, I.M., on day 1 (single treatment cycle)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
I.M., on day 1 (single treatment cycle)
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®)
Intervention Description
I.M. injection on day 1 (single treatment cycle)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
I.M. injection on day 1 (single treatment cycle)
Primary Outcome Measure Information:
Title
Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)
Description
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.
Time Frame
Baseline and Week 4
Secondary Outcome Measure Information:
Title
Physician's Global Assesment (PGA) of Treatment Response at Week 4
Description
An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA score at Week 4 is reported.
Time Frame
At Week 4
Title
Least Squares Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed
Description
Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Week 4 is reported.
Time Frame
Baseline and Week 4
Other Pre-specified Outcome Measures:
Title
Least Squares Mean Change From Baseline in MAS Score in the GSC (Knee Extended) at Weeks 1 and 12
Description
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 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 Weeks 1 and 12 are reported.
Time Frame
Baseline and Weeks 1 and 12
Title
Least Squares Mean Change From Baseline in MAS Score in the Soleus (Knee Flexed) at Weeks 1, 4 and 12
Description
Muscle tone in the treated limb was assessed by MAS in the soleus (with the knee flexed) 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 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 Weeks 1, 4 and 12 are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
Title
PGA of Treatment Response at Week 12
Description
An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA scores at Week 12 are reported.
Time Frame
At Week 12
Title
Least Squares Mean Change From Baseline in Comfortable Barefoot Walking Speed at Weeks 1 and 12
Description
Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1 and 12 are reported.
Time Frame
Baseline and Weeks 1 and 12
Title
Least Squares Mean Change From Baseline in Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12
Description
Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made with shoes, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
Title
Least Squares Mean Change From Baseline in Maximal Barefoot Walking Speed at Weeks 1, 4 and 12
Description
Maximal walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
Title
Least Squares Mean Change From Baseline in Maximal Walking Speed With Shoes at Weeks 1, 4 and 12
Description
Maximal walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made with shoes, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
Title
Least Squares Mean Change From Baseline in Cadence With Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12
Description
Cadence was assessed during the 10-metre walking speed test at comfortable walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
Title
Least Squares Mean Change From Baseline in Average Step Length With Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12
Description
Average step length was assessed during the 10-metre walking speed test at comfortable walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
Title
Least Squares Mean Change From Baseline in Cadence With Comfortable Barefoot Walking Speed at Weeks 1, 4 and 12
Description
Cadence was assessed during the 10-metre walking speed test at comfortable walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported
Time Frame
Baseline and Weeks 1, 4 and 12
Title
Least Squares Mean Change From Baseline in Average Step Length With Comfortable Barefoot Walking Speed at Weeks 1, 4 and 12
Description
Average step length was assessed during the 10-metre walking speed test at comfortable walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
Title
Least Squares Mean Change From Baseline in Cadence With Maximal Walking Speed With Shoes at Weeks 1, 4 and 12
Description
Cadence was assessed during the 10-metre walking speed test at maximal walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
Title
Least Squares Mean Change From Baseline in Average Step Length With Maximal Walking Speed With Shoes at Weeks 1, 4 and 12
Description
Average step length was assessed during the 10-metre walking speed test at maximal walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
Title
Least Squares Mean Change From Baseline in Cadence With Maximal Barefoot Walking Speed at Weeks 1, 4 and 12
Description
Cadence was assessed during the 10-metre walking speed test at maximal walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
Title
Least Squares Mean Change From Baseline in Average Step Length With Maximal Barefoot Walking Speed at Weeks 1, 4 and 12
Description
Average step length was assessed during the 10-metre walking speed test at maximal walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
Title
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)
Description
The Tardieu Scale in the GSC was used to assess spasticity with the knee extended. Assessments were made at slow (V1) and fast (V3) speeds of stretch. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest (XV1), either due to subject discomfort or a mechanical resistance. The same movement is repeated at a fast speed to determine the angle of catch and release (XV3). The spasticity angle (X) was calculated as the difference between XV1 and XV3. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
Title
Least Squares Mean Change From Baseline in the Tardieu Scale in the GSC (Knee Extended) at Weeks 1, 4 and 12: Spasticity Grade (Y)
Description
The Tardieu Scale in the GSC was used to assess spasticity with the knee extended. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 = no resistance throughout passive movement; 1 = slight resistance throughout passive movement; 2 = clear catch at precise angle, interrupting passive movement, followed by release; 3 = fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release; 4 = unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline for spasticity grade at Weeks 1, 4 and 12 are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
Title
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)
Description
The Tardieu Scale in the soleus was used to assess spasticity with the knee flexed. Assessments were made at slow (V1) and fast (V3) speeds of stretch. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest (XV1), either due to subject discomfort or a mechanical resistance. The same movement is repeated at a fast speed to determine the angle of catch and release (XV3). The spasticity angle (X) was calculated as the difference between XV1 and XV3. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
Title
Least Squares Mean Change From Baseline in the Tardieu Scale in the Soleus (Knee Flexed) at Weeks 1, 4 and 12: Spasticity Grade (Y)
Description
The Tardieu Scale in the soleus was used to assess spasticity with the knee flexed. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 = no resistance throughout passive movement; 1 = slight resistance throughout passive movement; 2 = clear catch at precise angle, interrupting passive movement, followed by release; 3 = fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release; 4 = unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline for spasticity grade at Weeks 1, 4 and 12 are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
Title
Least Squares Mean Change From Baseline in the Range of Active Dorsiflexion at Weeks 1, 4 and 12 (Knee Extended and Flexed)
Description
Range of active dorsiflexion of the ankle joint, both with the knee flexed (90°) and extended (measured by goniometry) was used to assess treatment response. The measurements were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits when needed at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
Title
Least Squares Mean Change From Baseline in Lower Limb Pain at Weeks 1, 4 and 12
Description
The intensity of lower limb pain was evaluated using the Scale of Pain Intensity (SPIN) which provided a pictorial representation of pain in a 6-point graphic scale with the degree of red shading inside a circle representing the intensity of pain. The bottom and top of the scale are anchored by two extremes: 'no pain' (circle with no red shading and scored as 0) and 'pain as bad as it could be' (circle completely red and scored as 5), marked with either verbal or visual cues. The intervening points are represented by red circles increasing proportionally in size. The subject marks the circle that best indicates their pain intensity. The SPIN assessments were obtained prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits when needed at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.
Time Frame
Baseline and Weeks 1, 4 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Study Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Rancho Los Amigos
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
Pacific Neuroscience Medical Group
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Associated Neurologists of Southern CT, PC
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Parkinson's Disease & Movement Disorders Center of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Design Neuroscience
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7200
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
MossRehab & Albert Einstein
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9016
Country
United States
Facility Name
University of North Texas HSC at Ben Hogan Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Neurorehabilitation Specialist
City
Houston
State/Province
Texas
ZIP/Postal Code
66211
Country
United States
Facility Name
University of Texas - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Epworth HealthCare
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Facility Name
Caulfield Hospital
City
Caulfield
ZIP/Postal Code
3162
Country
Australia
Facility Name
Saint Vincent's Hospital
City
Darlinghurst
Country
Australia
Facility Name
Saint Vincent's Hospital
City
Fitzroy
Country
Australia
Facility Name
St George Hospital
City
Kogarah
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
Country
Australia
Facility Name
Epworth Healthcare
City
Richmond
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
Country
Australia
Facility Name
Université catholique de Louvain av Hippocrate 10
City
Bruxelles
Country
Belgium
Facility Name
Clinique Universitaire
City
Yvoir
Country
Belgium
Facility Name
Neurologicka Klinika
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Neurologicka Klinika, VFN
City
Praha
ZIP/Postal Code
12000
Country
Czechia
Facility Name
CHU Jean MINJOZ
City
Besançon
Country
France
Facility Name
Service de Réeducation Fonctionnelle, CHU de Brest, Hôpital Morvan
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Centre de Réadaptation de Coubert
City
Coubert
Country
France
Facility Name
Centre Hospitalier Albert Chenevier
City
Créteil
Country
France
Facility Name
Hopital Raymond Poincarré
City
Garches
Country
France
Facility Name
Hôpital de L'Archet
City
Nice
Country
France
Facility Name
Hôpital Sébastopol, Médecine Physique et Réadaptation, CHU Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Hôpital Sébastopol
City
Reims
Country
France
Facility Name
Nouvel Civil Hospital
City
Strasbourg
Country
France
Facility Name
Hopital Rangueil
City
Toulouse
Country
France
Facility Name
National Institute for Medical Rehabilitation
City
Budapest
Country
Hungary
Facility Name
Szent János Hospital
City
Budapest
Country
Hungary
Facility Name
Uno Medical Trials
City
Budapest
Country
Hungary
Facility Name
Petz Aladar Country Hospital
City
Gyor
Country
Hungary
Facility Name
Batthyány Kázmér Hospital
City
Kisbér
Country
Hungary
Facility Name
Azienda Ospedaliero
City
Catania
Country
Italy
Facility Name
SSD Neurofisiologia Riabilitativa
City
Fossano
Country
Italy
Facility Name
Servizio di Neurofisiologia Clinica-Ospedale San Raffaele
City
Milano
Country
Italy
Facility Name
Polo IRCCS Eugenio Medea La Nostra Famiglia
City
Treviso
Country
Italy
Facility Name
Specjalistyczna Praktyka Lekarska
City
Katowice
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Krakow
Country
Poland
Facility Name
Krakowska Akademia Neurologii
City
Krakow
Country
Poland
Facility Name
Malopolskie Centrum Medyczne
City
Krakow
Country
Poland
Facility Name
Nzoz Neuro - Card
City
Poznan
Country
Poland
Facility Name
Samodzielny Publiczny Centralny Szpital
City
Warsaw
Country
Poland
Facility Name
Servicio de Rehabilitation de Adultos
City
Alcabideche
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Norte
City
Lisbon
Country
Portugal
Facility Name
Centro Hospitalar São João
City
Porto
Country
Portugal
Facility Name
Treatments and Rehabilitation Center
City
Moscow
Country
Russian Federation
Facility Name
State Institution "Scientific Centre of Neurology of Russian Academy of Medical Sciences"
City
Saint Petersburg
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
St-Petersberg State Medical University
City
St Petersburg
Country
Russian Federation
Facility Name
Neurologicka klinika, Univerzitna nemocnica Bratislava
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Univerzitna Nemocnica Bratislava
City
Bratislava
Country
Slovakia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
IPD Sharing URL
https://vivli.org/members/ourmembers/
Citations:
PubMed Identifier
32741133
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.
Results Reference
derived
PubMed Identifier
32108436
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.
Results Reference
derived
PubMed Identifier
29093068
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.
Results Reference
derived
Learn more about this trial
Dysport® Adult Lower Limb Spasticity Study
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