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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-05-31

Brief Summary

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

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Detailed Description

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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

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Muscle Spasticity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group 1

Meditoxin

Group Type EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Neuronox®, Siax®

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No