Phase III Clinical Trial of "Botulax®" to Treat Children With Cerebral Palsy
Phase 3
Completed
- Conditions
- Other Infantile Cerebral Palsy
- Interventions
- Drug: Botulinum Toxin Type A(Botox®)Drug: Botulinum toxin type A(Botulax®)
- Registration Number
- NCT01787344
- Lead Sponsor
- Hugel
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Botulinum toxin type A(Botox®) Botulinum Toxin Type A(Botox®) Botulinum toxin type A(Botox®) Botulinum toxin type A (Botulax®) Botulinum toxin type A(Botulax®) Botulinum toxin type A (Botulax®)
- Primary Outcome Measures
Name Time Method Rate of patients with an improvement more than two grade in Physician's Rating Scale score. at 12 weeks post-injection
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (6)
St. Vincent's hospital
🇰🇷Suwon, Kyunggi, Korea, Republic of
Samsung medical center - Changwon
🇰🇷Changwon, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Catholic university of Korea, Daejeon St. Mary's hospital
🇰🇷Daejeon, Korea, Republic of
Samsung medical center - Seoul
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's hospital
🇰🇷Seoul, Korea, Republic of
St. Vincent's hospital🇰🇷Suwon, Kyunggi, Korea, Republic of