Effectiveness and Safety of Dysport® (abobotulinumtoxinA) in Paediatric Lower Limb Spasticity

Completed

Conditions studied: Lower Limb Spasticity

In brief

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).

Key facts

Study ID

NCT03017729

Run by

Ipsen

People needed

242

Starts

2017-02-10

Expected to finish

2020-11-30

Last updated by the study team

2020-12-19

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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