Effectiveness and Safety of Dysport® (abobotulinumtoxinA) in Paediatric Lower Limb Spasticity
NCT ID: NCT03017729
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
242 participants
OBSERVATIONAL
2017-02-10
2020-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Botulinum toxin type A
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
2 Years
17 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Children's National Medical Center
Washington D.C., District of Columbia, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Laszlo J. Mate, M.D.
North Palm Beach, Florida, United States
Clinical Integrative Research Central Atlanta
Atlanta, Georgia, United States
Mt. Washington Pediatric Hospital
Baltimore, Maryland, United States
William Beaumont Hospital Pediatric Research
Royal Oak, Michigan, United States
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Valley Health System
Ridgewood, New Jersey, United States
Montefiore Medical Center
The Bronx, New York, United States
Akron Children's Hospital
Akron, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
The Children's Center
Bethany, Oklahoma, United States
Shriners Hospitals for Children
Portland, Oregon, United States
Good Shepherd Rehabilitation Network
Allentown, Pennsylvania, United States
Shriners Hospitals for Children
Philadelphia, Pennsylvania, United States
Shriners Hospitals for Children
Greenville, South Carolina, United States
Children's Hospital at Erlanger
Chattanooga, Tennessee, United States
Scottish Rite Hospital for Children
Dallas, Texas, United States
Shriners Hospitals for Children
Houston, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Texas Children's
Plano, Texas, United States
The Children's Hospital of San Antonio
San Antonio, Texas, United States
Utah Neuro Rehabilitation
Murray, Utah, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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A-US-52120-330
Identifier Type: -
Identifier Source: org_study_id