Loading clinical trials...

Phase III Clinical Trial of "Botulax®" to Treat Children With Cerebral Palsy | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

Double-blinded, Randomized, Active Control Comparative, Multicenter-designed, Phase III Clinical Trial to Evaluate the Safety and Efficacy of "Botulax®" Versus "Botox®" in Children With Cerebral Palsy

NCT01787344•Hugel

View on ClinicalTrials.gov

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.

Eligibility

Age

2 - 10 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Children patients ages from 2years old to 10years old.
•2. Patients who diagnosed with cerebral palsy.
•3. Patients who diagnosed as Gross Motor Function Classification System level I, II, or III
•4. Patients who diagnosed as dynamic equinus foot deformity
•5. Patients who agree with participation and signed to written agreement by substitute. (Get a signature from children patients if possible)deformity and I, II or III level of Gross Motor Function Classification System

Exclusion Criteria

•1. Patients who had previous injection of other botulinum toxin products in 3 months
•2. Patients with hypersensitivity history to botulinum toxin products previously
•3. Patients with neuromuscular junction disorder (myasthenia gravis, Lambert- Eaton syndrome, or amyotrophic lateral sclerosis, etc.)
•4. Those who have severe cardiovascular, kidney, liver, or respiratory diseases
•5. Those who are taking anticoagulant drugs or have bleeding disorder.
•6. Pratients with treatment of following drugs: Anticonvulsants, tranquilizers, narcotics, aminoglycoside antibiotics, muscle relaxtants like baclofen, blockers of parasympathetic nervous system, and levodopa.
•7. Patients who had history of surgery, plan to have surgery on legs, foot, or ankle.
•8. Patients who have evidence of fixed contractures regarding to Investigator
•9. Patients who have difference between two legs over 5cm
•10. Patients with severe athetoid movement
+3 more criteria

Locations (6)

St. Vincent's hospital

Suwon, Kyunggi, South Korea

Samsung medical center - Changwon

Changwon, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

Catholic university of Korea, Daejeon St. Mary's hospital

Daejeon, South Korea

Samsung medical center - Seoul

Seoul, South Korea

The Catholic University of Korea, Seoul St. Mary's hospital

Seoul, South Korea

Key Dates

Start Date

March 1, 2012

Primary Completion Date

June 1, 2014

Completion Date

August 1, 2014

Last Updated

May 4, 2015

Enrollment

144

ACTUAL participants

Conditions

Other Infantile Cerebral Palsy

Interventions

Botulinum Toxin Type A(Botox®)

DRUG

Botulinum toxin type A(Botulax®)

DRUG