Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children

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).

Timeline

Start

2014-04

Primary completion

2017-09-21

Completion

2018-09-04

Outcome

Met primary endpoint

registry Dysport 2 U/kg vs Dysport 8 U/kg; p = 0.0118; LS mean difference back transformed -0.4 NCT02106351 ↗

registry Dysport 2 U/kg vs Dysport 16 U/kg; p <0.0001; LS mean difference back transformed -0.7 NCT02106351 ↗

paper significantly lower Modified Ashworth scale scores versus the 2U/kg group (primary outcome: treatment differences of -0.4 [p=0.012] and -0.7 [p<0.001] respectively). PMID 33206382 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	2 iu/kg	Intramuscular
Subject	Botulinum toxin type A	Protein / enzyme biologic	8 iu/kg	Intramuscular
Subject	Botulinum toxin type A	Protein / enzyme biologic	16 iu/kg	Intramuscular

Indications

No indication recorded.