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

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

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.

Inclusion Criteria:

• Pediatric patients aged between 2 and 18 years with diagnosis of spastic cerebral palsy
• Patients with toe-walking due to peroneal muscle spasticity (patients with equinus foot deformity due to spasticity)
• Patients who voluntarily consent to participate in this study and whose legally acceptable representative has signed the informed consent form (if the patient is able to write, his/her signature should be also obtained).

Exclusion Criteria:

• Patients who had previously received botulinum toxin within 3 months prior to the study entry
• Patients with known hypersensitivity to botulinum toxin
• Patients who requires legs, feet or ankle surgery at present
• Patients with severe athetoid movement
• Patients who is participating in other investigational study at present
• Patients, by the investigator's discretion, who are not suitable for this study.