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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-08-31

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.

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Detailed Description

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Conditions

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Other Infantile Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Botulinum toxin type A (Botulax®)

Group Type EXPERIMENTAL

Botulinum toxin type A(Botulax®)

Intervention Type DRUG

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

Botulinum toxin type A(Botox®)

Group Type ACTIVE_COMPARATOR

Botulinum Toxin Type A(Botox®)

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
11. Patients who had other treatments related to dynamic equinus foot deformity, such as alcohol injection or muscle relaxants
12. 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.
13. Patients who have possibility to take prevented drugs
14. Subjects who are not eligible for this study based on investigator's judgement

Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No