NCT01256021

The Efficacy and Safety of MEDITOXIN® in Children With Cerebral Palsy

Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Safety and Efficacy of MEDITOXIN® in Children With Cerebral Palsy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Medy-Tox · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of children with cerebral palsy.

Detailed description

The allocated subject is injected Meditoxin® 4U/kg body weight(for patients with hemiplegia) or 6U/kg body weight(for patients with diplegia)in the affected gastrocnemius muscle for the treatment of patients who suffer Equinus Foot Deformity with pediatric cerebral palsy due to spasticity. The efficacy and safety are evaluated for 12weeks through 3 follow up visits.

Conditions

• Muscle Spasticity

Interventions

Type	Name	Description
DRUG	Botulinum Toxin Type A	1 time, gastrocnemius muscles injection, dose of 4U/kg body weight in patients with hemiplegia, dose of 6U/kg body weight in patients with diplegia, Maximum dosage 200U

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-02-01
• Completion: 2011-05-01
• First posted: 2010-12-08
• Last updated: 2019-03-27

Locations

4 sites across 1 country: South Korea