drugset / Trial / NCT01603615

BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity

NCT01603615 ↗

Phase 3 Completed 220 enrolled Allergan
NaSingle-groupOpen-labelTreatment

Summary

This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric upper limb spasticity.

Timeline

Start
2012-10-30
Primary completion
2018-09-03
Completion
2018-09-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 6 iu/kg Intramuscular
Subject Botulinum toxin type A Protein / enzyme biologic 8 iu/kg Intramuscular
Subject Botulinum toxin type A Protein / enzyme biologic 10 iu/kg Intramuscular