Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the longitudinal attainment of subject centred and functional related goals (cumulated Goal Attainment Scale Total (GAS T) score) after abobotulinumtoxinA injection (including following repeated injection cycles where they occur) alongside spasticity management used in real life settings over a period of 18 months (and a maximum of six injection cycles).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological | This is an observational study designed to reflect real world clinical practice in the use of abobotulinumtoxinA. AbobotulinumtoxinA injected doses, frequency of injections, number of injection sites and volume injected per site are in accordance with the current USPI and physician's clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulated GAS T score | Defined as the mean of the individual GAS T scores across all cycles will be used to measure progress towards individual therapy goals. If all goals are achieved as expected, the GAS T score is 50.0. | From day 1 up to 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| AbobotulinumtoxinA dose | During each injection cycle and overall | Day 1, then every 3.5 months (approximately) up to 30 months |
| Time intervals between injections | During each injection cycle and overall |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Pediatric patients with lower limb spasticity
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Nicklaus Children's Hospital |
Not provided
Not provided
Not provided
Not provided
| Day 1, then every 3.5 months (approximately) up to 30 months |
| Number of injection points | During each injection cycle and overall | Day 1, then every 3.5 months (approximately) up to 30 months |
| Muscle(s) injected | During each injection cycle and overall | Day 1, then every 3.5 months (approximately) up to 30 months |
| Sedation used | During each injection cycle and overall | Day 1, then every 3.5 months (approximately) up to 30 months |
| Type of injection guidance utilised | During each injection cycle and overall | Day 1, then every 3.5 months (approximately) up to 30 months |
| Concomitant drug therapies | Listed and tabulated by frequency | From day 1 up to 30 months |
| Non-drug therapies | Listed and tabulated by frequency | From day 1 up to 30 months |
| Modified Ashworth scale (as applicable) in the injected muscle groups (gastrocnemius, soleus and others) at baseline and per the investigators' decision/routine practice during the course of the study. | This evaluation will not be mandatory during this study. Response over time will be presented using descriptive statistics. | From day 1 up to 30 months (per investigator's decision/routine practice) |
| Average GAS T score | Per injection cycle | Day 1 then every 3.5 months (approximately) up to 30 months |
| Percentage achievement of primary treatment goal | During each injection cycle and overall | Day 1 then every 3.5 months (approximately) up to 30 months |
| Percentage achievement of primary treatment goal(s) per goal area(s) after repeated abobotulinumtoxinA injections | Per injection cycle | Day 1 then every 3.5 months (approximately) up to 30 months |
| Incidence of adverse events and special situations collected | Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). | From day 1 up to 30 months |
| Direct and indirect health care costs | Derived from the collected data, including concomitant treatments. | From day 1 up to 30 months |
| Miami |
| Florida |
| 33155 |
| United States |
| Laszlo J. Mate, M.D. | North Palm Beach | Florida | 33408 | United States |
| Clinical Integrative Research Central Atlanta | Atlanta | Georgia | 30328 | United States |
| Mt. Washington Pediatric Hospital | Baltimore | Maryland | 21209 | United States |
| William Beaumont Hospital Pediatric Research | Royal Oak | Michigan | 48073 | United States |
| Gillette Children's Specialty Healthcare | Saint Paul | Minnesota | 55101 | United States |
| University of Missouri | Columbia | Missouri | 65212 | United States |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | United States |
| Valley Health System | Ridgewood | New Jersey | 07450 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | United States |
| The Children's Center | Bethany | Oklahoma | 73008 | United States |
| Shriners Hospitals for Children | Portland | Oregon | 97239 | United States |
| Good Shepherd Rehabilitation Network | Allentown | Pennsylvania | 18103 | United States |
| Shriners Hospitals for Children | Philadelphia | Pennsylvania | 19140 | United States |
| Shriners Hospitals for Children | Greenville | South Carolina | 29605 | United States |
| Children's Hospital at Erlanger | Chattanooga | Tennessee | 37403 | United States |
| Scottish Rite Hospital for Children | Dallas | Texas | 75219 | United States |
| Shriners Hospitals for Children | Houston | Texas | 77030 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Texas Children's | Plano | Texas | 75024 | United States |
| The Children's Hospital of San Antonio | San Antonio | Texas | 78207 | United States |
| Utah Neuro Rehabilitation | Murray | Utah | 84124 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| 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