drugset / Trial / NCT01251380

Dysport® Pediatric Lower Limb Spasticity Follow-on Study

NCT01251380 ↗

Phase 3 Completed 216 enrolled Ipsen
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this research study was to determine the long term safety and efficacy of repeated treatments with Dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.

Timeline

Start
2011-10
Primary completion
2015-01
Completion
2015-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 5 iu/kg Intramuscular
Subject Botulinum toxin type A Protein / enzyme biologic 10 iu/kg Intramuscular
Subject Botulinum toxin type A Protein / enzyme biologic 20 iu/kg Intramuscular
Subject Botulinum toxin type A Protein / enzyme biologic 30 iu/kg Intramuscular
Subject Botulinum toxin type A Protein / enzyme biologic 1000 iu Intramuscular

Indications