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



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:2 - 17
Updated:12/23/2018
Start Date:February 10, 2017
End Date:November 2020

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A Phase IV, Prospective, Observational, Multicentre Study Evaluating the Effectiveness and Safety of Dysport® (abobotulinumtoxinA) in Paediatric Lower Limb Spasticity.

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).


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
27
sites
Allentown, Pennsylvania 18103
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1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Principal Investigator: Christopher Najarian
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Yuxi Chen
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Mohammed Aldosari
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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750 Hammond Drive Northeast
Atlanta, Georgia 30328
Principal Investigator: Frank Berenson
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Atlanta, GA
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Baltimore, Maryland 21209
Principal Investigator: Stephen Nichols
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Bethany, Oklahoma 73008
Principal Investigator: Steven Couch
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Chattanooga, Tennessee 37403
Principal Investigator: Lewis Miller
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Columbia, Missouri 65211
(573) 882-2121
Principal Investigator: Jane Emerson
University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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2222 Welborn Street
Dallas, Texas 75219
Principal Investigator: Mauricio Delgado
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Dallas, TX
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Dayton, Ohio 45404
Principal Investigator: Michelle Potts
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Dayton, OH
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Greenville, South Carolina 29605
Principal Investigator: David Westberry
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Houston, Texas 77030
Principal Investigator: Stacey Hall
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Houston, TX
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Rochelle Dy
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Houston, TX
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Miami, Florida 33155
Principal Investigator: Migvis Monduy
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Principal Investigator: Karin Goodfriend
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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Milwaukee, WI
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1414 East 4500 South
Murray, Utah 84124
Principal Investigator: Judy Gooch
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Murray, UT
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North Palm Beach, Florida 33408
Principal Investigator: Laszlo Mate
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North Palm Beach, FL
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Philadelphia, Pennsylvania 19140
Principal Investigator: Betheny Lipa
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7601 Preston Road
Plano, Texas 75024
Principal Investigator: Didem Inanoglu
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Portland, Oregon 97239
Principal Investigator: Jenny Wilson
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Portland, OR
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Ridgewood, New Jersey 07450
Principal Investigator: Angela D'Alessandro
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Ridgewood, NJ
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3601 West 13 Mile Road
Royal Oak, Michigan 48073
Principal Investigator: Edward Dabrowski
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Royal Oak, MI
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Brad Racette
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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Saint Paul, Minnesota 55101
Principal Investigator: Mark Gormley
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San Antonio, Texas 78207
Principal Investigator: Donald Currie
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San Antonio, TX
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Sarah Evans
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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