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

Medytox

Status and phase

Completed

Phase 4

Conditions

Muscle Spasticity

Treatments

Drug: Botulinum Toxin Type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT01256021

MT_PRT_CP02

Details and patient eligibility

About

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

Full 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.

Enrollment

212 patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

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.