Status:
COMPLETED
The Efficacy and Safety of MEDITOXIN® in Children With Cerebral Palsy
Lead Sponsor:
Medy-Tox
Conditions:
Muscle Spasticity
Eligibility:
All Genders
2-18 years
Phase:
PHASE4
Brief 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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT01256021
Start Date
August 1 2010
End Date
May 1 2011
Last Update
March 27 2019
Active Locations (4)
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1
Seoul National University Bundang Hospital
Seongnam, South Korea
2
Seoul National Universtiy Hospital
Seoul, South Korea, 110-744
3
Asan Medical Center
Seoul, South Korea
4
Yonsei University Severance Hospital
Seoul, South Korea