Phase 3
Completed N=212
Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children
Upper Limb Spasticity (Altered Skeletal Muscle Performance) in Children
Source: ClinicalTrials.gov NCT02106351 ↗
Enrolled (actual)
212
Serious AEs
4.2%
Results posted
Dec 2019
Primary outcomePrimary: Mean Change From Baseline to TC 1, Week 6 in MAS Score in the TC 1 PTMG — -1.5; -1.9; -2.2 score on a scale — p=0.0118
◆ Published Evidence
Established
37citations · ~7 / year
Efficacy and safety of abobotulinumtoxinA for upper limb spasticity in children with cerebral palsy: a randomized repeat-treatment study.
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).
Linked Publications (2)
-
Efficacy and safety of abobotulinumtoxinA for upper limb spasticity in children with cerebral palsy: a randomized repeat-treatment study.
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Development of a Pediatric Goal-Centered Upper Limb Spasticity Home Exercise Therapy Program for Use in a Phase-III Trial of Abobotulinumtoxina (Dysport<sup>®</sup>).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to TC 1, Week 6 in MAS Score in the TC 1 PTMG |
-1.5; -1.9; -2.2 | 0.0118 sig |
| SECONDARY Mean Physician's Global Assessment (PGA) Score at TC 1, Week 6 |
1.7; 2.0; 2.0 | 0.2043 |
| SECONDARY Mean Goal Attainment Scale (GAS) Total Score at TC 1, Week 6 |
51.3; 52.6; 52.0 | 0.7648 |
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
Data sourced from ClinicalTrials.gov (NCT02106351) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.