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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Other Infantile Cerebral Palsy

Intervention / Treatment
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* Drug: Botulinum Toxin Type A(Botox®)
* Drug: Botulinum toxin type A(Botulax®)


Participation Criteria
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Eligibility Criteria
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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 Patients who had other treatments related to dynamic equinus foot deformity, such as alcohol injection or muscle relaxants Those who were not enrolled in other studies within 30 days, or were not paseed over 5 times of half life for clinical trial drugs. Patients who have possibility to take prevented drugs Subjects who are not eligible for this study based on investigator's judgement

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin type A (Botulax®)<br>Botulinum toxin type A (Botulax®) | Drug: Botulinum toxin type A(Botulax®)<br>* Single administration, 4units/kg body weight dose in patients with hemiplegia,6units/kg body weight dose in patients with diplegia, Maximum dosage 200units<br>|
| Active Comparator: Botulinum toxin type A(Botox®)<br>Botulinum toxin type A(Botox®) | Drug: Botulinum Toxin Type A(Botox®)<br>* Single administration, 4units/kg body weight dose in patients with hemiplegia, 6units/kg body weight dose in patients with diplegia, Maximum dosage 200units<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with an improvement more than two grade in Physician's Rating Scale score. |  | at 12 weeks post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| Rate of change in Modified Tardieu Scale(Ankle DF), compare to baseline. |  | at 6, 12 and 24 weeks post-injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Other Infantile Cerebral Palsy