Other Infantile Cerebral Palsy Clinical Trial
Official title:
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
| Verified date | April 2015 |
| Source | Hugel |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Ministry of Food and Drug Safety |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 144 |
| Est. completion date | August 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years to 10 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Hugel |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of patients with an improvement more than two grade in Physician's Rating Scale score. | at 12 weeks post-injection | No | |
| Secondary | 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 | No | |
| Secondary | Rate of change in Passive range of motion, compare to baseline. | at 6, 12 and 24 weeks post-injection | No | |
| Secondary | Rate of change in Gross Motor Function Measure 88, 66, compare to baseline. | at 6, 12 and 24 weeks post-injection | No | |
| Secondary | Rate of change in Modified Tardieu Scale(Ankle DF), compare to baseline. | at 6, 12 and 24 weeks post-injection | No |