NCT02106351

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Upper Limb Spasticity (Altered Skeletal Muscle Performance) in Children

Interventions

Type	Name	Description
BIOLOGICAL	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.

Timeline

• Start date: 2014-04-01
• Primary completion: 2017-09-21
• Completion: 2018-09-04
• First posted: 2014-04-08
• Last updated: 2022-09-28
• Results posted: 2019-12-24

Locations

31 sites across 8 countries: United States, Belgium, Czechia, Israel, Mexico, Poland, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study