drugset / Trial / NCT01787344

Phase III Clinical Trial of "Botulax®" to Treat Children With Cerebral Palsy

NCT01787344

Phase 3 Completed 144 enrolled Hugel
RandomizedParallel-groupDouble-blindTreatment

Summary

To compare the safety and efficacy of Botulax Inj.®(Botulinum toxin type A, Hugel, South Korea) with Botox Inj.® (Botulinum toxin type A, Allergan, USA) in the treatment of cerebral palsy in children.

Timeline

Start
2012-03
Primary completion
2014-06
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic 4 iu/kg
Comparator Botulinum toxin type A Protein / enzyme biologic 6 iu/kg

Indications