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

Hugel6 sites in 1 country144 target enrollmentMarch 2012

ConditionsOther Infantile Cerebral Palsy

InterventionsBotulinum toxin type A(Botulax®)Botulinum Toxin Type A(Botox®)

DrugsBotulinum Toxin Type A(Botox®)Botulinum toxin type A(Botulax®)

Overview

Phase: Phase 3
Intervention: Botulinum toxin type A(Botulax®)
Conditions: Other Infantile Cerebral Palsy
Sponsor: Hugel
Enrollment: 144
Locations: 6
Primary Endpoint: Rate of patients with an improvement more than two grade in Physician's Rating Scale score.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

August 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hugel

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Children patients ages from 2years old to 10years old.
•Patients who diagnosed with cerebral palsy.
•Patients who diagnosed as Gross Motor Function Classification System level I, II, or III
•Patients who diagnosed as dynamic equinus foot deformity
•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

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

Arms & Interventions

Botulinum toxin type A (Botulax®)

Intervention: Botulinum toxin type A(Botulax®)

Botulinum toxin type A(Botox®)

Intervention: Botulinum Toxin Type A(Botox®)

Outcomes

Primary Outcomes

Rate of patients with an improvement more than two grade in Physician's Rating Scale score.

Time Frame: at 12 weeks post-injection

Secondary Outcomes

Rate of patients with an improvement more than two grade in Physician's Rating Scale score, comparing to baseline.(at 6 and 24weeks post-injection)
Rate of change in Modified Tardieu Scale(Ankle DF), compare to baseline.(at 6, 12 and 24 weeks post-injection)
Rate of change in Passive range of motion, compare to baseline.(at 6, 12 and 24 weeks post-injection)
Rate of change in Gross Motor Function Measure 88, 66, compare to baseline.(at 6, 12 and 24 weeks post-injection)