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

NCT01256021 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2019-03-27

No results posted yet for this study

Summary

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

Conditions

  • Muscle Spasticity

Interventions

DRUG

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

Sponsors & Collaborators

  • Medy-Tox

    lead INDUSTRY

Principal Investigators

  • Eun S Park, Ph D · Severance Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-02-28
Completion
2011-05-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01256021 on ClinicalTrials.gov