Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019069-28 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysport 500 U | Experimental |
| |
| Dysport 1000 U | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological | 500 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Global Assessment (PGA) of Treatment Response | PGA is a 9-point scale used to assess global overall treatment response by the investigator (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved). | At Week 4 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ipsen Study Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rancho Los Amigos National Rehabilitation Center | Downey | California | 90242 | United States | ||
| Associated Neurologist of Southern CT, PT |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29781237 | Derived | 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. | |
| 28634000 | Derived | 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. |
Not provided
Not provided
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.
Not provided
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.
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Not provided
This multicenter study was conducted in 34 investigational sites. Subjects screened were 281 and randomised and treated were 243.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo intramuscular injection single treatment cycle on day 1 |
| FG001 | Dysport 500 U | Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Botulinum toxin type A | Biological | 1000 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle. |
|
|
| Placebo | Drug | I.M. (in the muscle) injection on day 1 of a single treatment cycle. |
|
| Change From Baseline in DAS Score for the Principal Target of Treatment (PTT) |
DAS is a 4-point scale used to determine the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain). DAS scale rating: 0=No disability, 1=Mild disability (noticeable but does not interfere significantly with normal activities), 2=Moderate disability (normal activities require increased effort and/or assistance) and 3=Severe disability (normal activities limited). If subject chose 'Hygiene' as PTT the score collected will be between 0 and 3. |
| From Baseline (Day 1) to Week 4 |
| 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 |
| 28625615 | Derived | 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. |
| 26318836 | Derived | 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. |
| FG002 | Dysport 1000 U | Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo intramuscular injection single treatment cycle on day 1 |
| BG001 | Dysport 500 U | Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1 |
| BG002 | Dysport 1000 U | Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Ethnicity | Number | participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Placebo: N=78, Dysport 500 U: N=80, and Dysport 1000 U: N=80. | Mean | Standard Deviation | kg/m2 |
| ||||||||||||||
| Modified Ashworth Scale (MAS) | MAS scale is used to assess muscle tone (MT) using a 6-point scale where:0=No increase in MT, 1=Slight increase in MT,1±=Slight increase in MT manifested by a catch followed by minimal resistance throughout remainder of ROM,2=Marked increase in MT through most of ROM but affected part easily moved,3=Considerable increase in MT 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. Placebo:N=79, Dysport 500U:N=80 & Dysport 1000U:N=79. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Disability Assessment Scale (DAS) | DAS is a 4-point scale used to determine the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain). DAS scale rating: 0=No disability, 1=Mild disability (noticeable but does not interfere significantly with normal activities), 2=Moderate disability (normal activities require increased effort and/or assistance) and 3=Severe disability (normal activities limited). If the subject chose Hygiene as PTT the score collected will be between 0 and 3. Placebo: N=79, Dysport 500 U: N=80 and Dysport 1000 U: N=79. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Physician's Global Assessment (PGA) of Treatment Response | PGA is a 9-point scale used to assess global overall treatment response by the investigator (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved). | ITT population. Two subjects each from Placebo and Dysport 1000 U had missed PGA assessment at week 4 | Posted | Mean | Standard Deviation | units on a scale | At Week 4 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in DAS Score for the Principal Target of Treatment (PTT) | DAS is a 4-point scale used to determine the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain). DAS scale rating: 0=No disability, 1=Mild disability (noticeable but does not interfere significantly with normal activities), 2=Moderate disability (normal activities require increased effort and/or assistance) and 3=Severe disability (normal activities limited). If subject chose 'Hygiene' as PTT the score collected will be between 0 and 3. | ITT population. Two subjects each from Placebo and Dysport 1000 U had missed DAS assessment at baseline and week 4. | Posted | Mean | Standard Deviation | units on a scale | From Baseline (Day 1) to Week 4 |
| |||||||||||||||||||||||||||||||||
| Primary | 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. | Intention to treat (ITT) population included all randomized subjects who received at least one injection of study drug and had a MAS score at baseline (pretreatment) and at week 4. Total 5 subjects were excluded from ITT population as they did not have MAS score at baseline or/and at week 4. | Posted | Mean | Standard Deviation | units on a scale | From Baseline (Day 1) to Week 4 |
|
Up to 24±2 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo intramuscular injection single treatment cycle on day 1 | 3 | 81 | 10 | 81 | ||
| EG001 | Dysport 500 U | Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1 | 3 | 81 | 25 | 81 | ||
| EG002 | Dysport 1000 U | Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1 | 3 | 81 | 18 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Behcet's syndrome | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 16.0 | Systematic Assessment | General disorders and administration site conditions |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infections | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gamma glutamyl transferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Neurology | Ipsen | clinical.trials@ipsen.com | clinical.trials@ipsen.com |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| Black/African American |
|
| Caucasian/White |
|
| Multiple |
|
| Not Hispanic/Latino |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Dysport 1000 U |
Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1 |
|
|