Effectiveness and Safety of Dysport® (abobotulinumtoxinA) in Paediatric Lower Limb Spasticity
A Phase IV, Prospective, Observational, Multicentre Study Evaluating the Effectiveness and Safety of Dysport® (abobotulinumtoxinA) in Paediatric Lower Limb Spasticity.
1 other identifier
observational
242
1 country
27
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
Typical duration for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2016
CompletedFirst Posted
Study publicly available on registry
January 11, 2017
CompletedStudy Start
First participant enrolled
February 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedDecember 19, 2020
December 1, 2020
3.8 years
December 30, 2016
December 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (14)
AbobotulinumtoxinA dose
Day 1, then every 3.5 months (approximately) up to 30 months
Time intervals between injections
Day 1, then every 3.5 months (approximately) up to 30 months
Number of injection points
Day 1, then every 3.5 months (approximately) up to 30 months
Muscle(s) injected
Day 1, then every 3.5 months (approximately) up to 30 months
Sedation used
Day 1, then every 3.5 months (approximately) up to 30 months
- +9 more secondary outcomes
Interventions
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.
Eligibility Criteria
Pediatric patients with lower limb spasticity
You may qualify if:
- Female or male subjects aged 2 to 17 years inclusive
- Decision to prescribe abobotulinumtoxinA, to be made prior to and independently from the decision to enroll in the study
- Primary diagnosis of paediatric lower limb (PLL) spasticity and either: Previously untreated with BoNT (naïve to BoNT), or previously treated with a BoNT (i.e. non naïve to BoNT), and for those who were previously treated with BoNT-A, they should have responded to BoNT-A treatment according to the investigator's criteria
- For non naïve BoNT subjects, a minimum interval of 12 weeks since the last BoNT injection and in the presence of spasticity
You may not qualify if:
- Known resistance to any BoNT or experienced serious safety issues with previous use of BoNT
- Concomitant treatment with other BoNT
- Known hypersensitivity to abobotulinumtoxinA or related compounds, or any component in the study drug formulation
- Subjects with any clinical (or subclinical) evidence of marked defective neuromuscular transmission (e.g. Lambert Eaton syndrome or myasthenia gravis) or persistent clinically significant neuromuscular disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (27)
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Nicklaus Children's Hospital
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2016
First Posted
January 11, 2017
Study Start
February 10, 2017
Primary Completion
November 30, 2020
Study Completion
November 30, 2020
Last Updated
December 19, 2020
Record last verified: 2020-12