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Phase III Clinical Trial of "Botulax®" to Treat Children With Cerebral Palsy

NCT01787344 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2015-05-04

No results posted yet for this study

Summary

To compare the safety and efficacy of Botulax Inj.®(Botulinum toxin type A, Hugel, South Korea) with Botox Inj.® (Botulinum toxin type A, Allergan, USA) in the treatment of cerebral palsy in children.

Conditions

  • Other Infantile Cerebral Palsy

Interventions

DRUG

Botulinum Toxin Type A(Botox®)

Single administration, 4units/kg body weight dose in patients with hemiplegia, 6units/kg body weight dose in patients with diplegia, Maximum dosage 200units

DRUG

Botulinum toxin type A(Botulax®)

Single administration, 4units/kg body weight dose in patients with hemiplegia,6units/kg body weight dose in patients with diplegia, Maximum dosage 200units

Sponsors & Collaborators

  • Hugel

    lead INDUSTRY

Principal Investigators

  • Jeong-yi Kwon, M.D., Ph.D. · Samsung Medical Center -Seoul

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-06-30
Completion
2014-08-31

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 NCT01787344 on ClinicalTrials.gov