Clinical trial NCT02106351: Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children
Official title: A Phase III, Multicentre, Double Blind, Prospective, Randomised, Controlled, Multiple Treatment Study Assessing Efficacy And Safety Of DYSPORT® Used In The Treatment Of Upper Limb Spasticity In Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Upper Limb Spasticity (Altered Skeletal Muscle Performance) in Children
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 212
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport used in the treatment of upper limb spasticity (altered skeletal muscle performance) in children with cerebral palsy (CP).


Eligibility criteria: Inclusion Criteria:

* Upper limb spasticity due to cerebral palsy
* Body weight 10 kg or over
* MAS score of 2 or more in affected elbow or wrist flexors

Exclusion Criteria:

* Fixed myocontracture
* 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

Primary outcomes:
measure: Mean Change From Baseline to TC 1, Week 6 in MAS Score in the TC 1 PTMG
timeFrame: Baseline (TC 1, Day 1) and TC 1, Week 6.
Secondary outcomes:
measure: Mean Physician's Global Assessment (PGA) Score at TC 1, Week 6
timeFrame: TC 1, Week 6.
measure: Mean Goal Attainment Scale (GAS) Total Score at TC 1, Week 6
timeFrame: TC 1, Week 6.
Other outcomes:
measure: Mean Change From Baseline to TC 1 Week 16 in MAS Score in the TC 1 PTMG
timeFrame: Baseline (TC 1, Day 1) and TC 1, Week 16.
measure: Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Elbow Flexors of the Study Limb
timeFrame: Baseline (TC 1, Day 1) and TC 1, Weeks 6 and 16.
measure: Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Wrist Flexors of the Study Limb
timeFrame: Baseline (TC 1, Day 1) and TC 1, Weeks 6 and 16.
measure: Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Finger Flexors of the Study Limb
timeFrame: Baseline (TC 1, Day 1) and TC 1, Weeks 6 and 16.
measure: Mean PGA Score at TC 1 Week 16
timeFrame: Baseline (TC 1, Day 1) and TC 1, Week 16.
measure: Mean GAS Total Score at TC 1, Week 16
timeFrame: Baseline (TC 1, Day 1) and TC 1, Week 16.
measure: Mean Change From Baseline to TC 1, Week 16 in the Paediatric Quality of Life (PedsQL) Scores
timeFrame: Baseline (TC 1, Day 1) and TC 1, Week 16.
Locations:
city: Aurora
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: New Orleans
country: United States
state: Louisiana
city: Royal Oak
country: United States
state: Michigan
city: Saint Paul
country: United States
state: Minnesota
city: Omaha
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Brussels
country: Belgium
city: Brno
country: Czechia
city: Prague
country: Czechia
city: Be'er Sheva
country: Israel
city: Jerusalem
country: Israel
city: Petaẖ Tiqwa
country: Israel
city: Tel Aviv
country: Israel
city: Tel Hashomer
country: Israel
city: La Paz
country: Mexico
state: Baja California Sur
city: Celaya
country: Mexico
city: Monterrey
country: Mexico
city: Gdansk
country: Poland
city: Poznan
country: Poland
city: Wiazowna
country: Poland
city: Barcelona
country: Spain
city: Terrassa
country: Spain
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Kocaeli
country: Turkey
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.