Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children
NCT ID: NCT02106351
Last Updated: 2022-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
212 participants
INTERVENTIONAL
2014-04-30
2018-09-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A
Group A - Treatments 1, 2, 3 and 4: Dysport 16 Units (U)/kg in one upper extremity (the study limb).
Botulinum toxin type A
Subjects randomised to receive Dysport 2 U/kg, 8 U/kg or 16 U/kg administered intramuscularly in the study limb.
Group B
Group B - Treatments 1, 2, 3 and 4: Dysport 8 U/kg in one upper extremity (the study limb).
Botulinum toxin type A
Subjects randomised to receive Dysport 2 U/kg, 8 U/kg or 16 U/kg administered intramuscularly in the study limb.
Group C
Group C - Treatment 1: Dysport 2 U/kg in one upper extremity (the study limb).
Group C - Treatments 2, 3 and 4: Dysport 8 or 16 U/kg in one upper extremity (the study limb).
Botulinum toxin type A
Subjects randomised to receive Dysport 2 U/kg, 8 U/kg or 16 U/kg administered intramuscularly in the study limb.
Interventions
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Botulinum toxin type A
Subjects randomised to receive Dysport 2 U/kg, 8 U/kg or 16 U/kg administered intramuscularly in the study limb.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body weight 10 kg or over
* MAS score of 2 or more in affected elbow or wrist flexors
Exclusion Criteria
* Previous phenol or alcohol injection within 1 year
* Severe athetoid or dystonic movements
* Previous or planned surgery for spasticity in elbow or wrist flexors
* Neuromuscular disorders
* Previous Rhizotomy within 6 months
* Intrathecal baclofen within 30 days
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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Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
New Orleans, Louisiana, United States
Royal Oak, Michigan, United States
Saint Paul, Minnesota, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Austin, Texas, United States
Dallas, Texas, United States
Brussels, , Belgium
Brno, , Czechia
Prague, , Czechia
Beersheba, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
La Paz, Baja California Sur, Mexico
Celaya, , Mexico
Monterrey, , Mexico
Gdansk, , Poland
Poznan, , Poland
Wiązowna, , Poland
Barcelona, , Spain
Terrassa, , Spain
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Kocaeli, , Turkey (Türkiye)
Countries
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References
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Delgado MR, Tilton A, Carranza-Del Rio J, Dursun N, Bonikowski M, Aydin R, Maciag-Tymecka I, Oleszek J, Dabrowski E, Grandoulier AS, Picaut P; Dysport in PUL study group. Efficacy and safety of abobotulinumtoxinA for upper limb spasticity in children with cerebral palsy: a randomized repeat-treatment study. Dev Med Child Neurol. 2021 May;63(5):592-600. doi: 10.1111/dmcn.14733. Epub 2020 Nov 18.
Shierk A, Jimenez-Moreno AC, Roberts H, Ackerman-Laufer S, Backer G, Bard-Pondarre R, Cekmece C, Pyrzanowska W, Vilain C, Delgado MR. Development of a Pediatric Goal-Centered Upper Limb Spasticity Home Exercise Therapy Program for Use in a Phase-III Trial of Abobotulinumtoxina (Dysport(R)). Phys Occup Ther Pediatr. 2019;39(2):124-135. doi: 10.1080/01942638.2018.1486346. Epub 2018 Sep 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2010-021817-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Y-52-52120-153
Identifier Type: -
Identifier Source: org_study_id
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