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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin type A (Botulax®) | Experimental | Botulinum toxin type A (Botulax®) |
|
| Botulinum toxin type A(Botox®) | Active Comparator | Botulinum toxin type A(Botox®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A(Botox®) | Drug | Single administration, 4units/kg body weight dose in patients with hemiplegia, 6units/kg body weight dose in patients with diplegia, Maximum dosage 200units |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeong-yi Kwon, M.D., Ph.D. | Samsung Medical Center -Seoul | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's hospital | Suwon | Kyunggi | South Korea | |||
| Samsung medical center - Changwon |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Botulinum toxin type A(Botulax®) | Drug | Single administration, 4units/kg body weight dose in patients with hemiplegia,6units/kg body weight dose in patients with diplegia, Maximum dosage 200units |
|
| 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 |
| Changwon |
| South Korea |
| Keimyung University Dongsan Medical Center | Daegu | South Korea |
| Catholic university of Korea, Daejeon St. Mary's hospital | Daejeon | South Korea |
| Samsung medical center - Seoul | Seoul | South Korea |
| The Catholic University of Korea, Seoul St. Mary's hospital | Seoul | South Korea |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |