NCT01787344

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

Double-blinded, Randomized, Active Control Comparative, Multicenter-designed, Phase III Clinical Trial to Evaluate the Safety and Efficacy of "Botulax®" Versus "Botox®" in Children With Cerebral Palsy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Hugel · Industry
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Other Infantile Cerebral Palsy

Interventions

Type	Name	Description
DRUG	Botulinum Toxin Type A(Botox®)	Single administration, 4units/kg body weight dose in patients with hemiplegia, 6units/kg body weight dose in patients with diplegia, Maximum dosage 200units
DRUG	Botulinum toxin type A(Botulax®)	Single administration, 4units/kg body weight dose in patients with hemiplegia,6units/kg body weight dose in patients with diplegia, Maximum dosage 200units

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-06-01
• Completion: 2014-08-01
• First posted: 2013-02-08
• Last updated: 2015-05-04

Locations

6 sites across 1 country: South Korea