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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medy-Tox
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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.