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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
144
Single administration, 4units/kg body weight dose in patients with hemiplegia, 6units/kg body weight dose in patients with diplegia, Maximum dosage 200units
Single administration, 4units/kg body weight dose in patients with hemiplegia,6units/kg body weight dose in patients with diplegia, Maximum dosage 200units
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
Rate of patients with an improvement more than two grade in Physician's Rating Scale score.
Time frame: at 12 weeks post-injection
Rate of patients with an improvement more than two grade in Physician's Rating Scale score, comparing to baseline.
Time frame: at 6 and 24weeks post-injection
Rate of change in Passive range of motion, compare to baseline.
Time frame: at 6, 12 and 24 weeks post-injection
Rate of change in Gross Motor Function Measure 88, 66, compare to baseline.
Time frame: at 6, 12 and 24 weeks post-injection
Rate of change in Modified Tardieu Scale(Ankle DF), compare to baseline.
Time frame: at 6, 12 and 24 weeks post-injection
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Samsung medical center - Seoul
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's hospital
Seoul, South Korea