Clinical trial NCT01787344: Phase III Clinical Trial of "Botulax®" to Treat Children With Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Other Infantile Cerebral Palsy
Keywords: Other Infantile Cerebral Palsy
Lead sponsor: Hugel
Sponsor class: INDUSTRY
First posted: 2013-02-08
Enrollment: 144
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of patients with an improvement more than two grade in Physician's Rating Scale score.
timeFrame: at 12 weeks post-injection
Secondary outcomes:
measure: Rate of patients with an improvement more than two grade in Physician's Rating Scale score, comparing to baseline.
timeFrame: at 6 and 24weeks post-injection
measure: Rate of change in Passive range of motion, compare to baseline.
timeFrame: at 6, 12 and 24 weeks post-injection
measure: Rate of change in Gross Motor Function Measure 88, 66, compare to baseline.
timeFrame: at 6, 12 and 24 weeks post-injection
measure: Rate of change in Modified Tardieu Scale(Ankle DF), compare to baseline.
timeFrame: at 6, 12 and 24 weeks post-injection
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: St. Vincent's hospital
state: Kyunggi
city: Changwon
country: Korea, Republic of
facility: Samsung medical center - Changwon
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Catholic university of Korea, Daejeon St. Mary's hospital
city: Seoul
country: Korea, Republic of
facility: Samsung medical center - Seoul
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's hospital
Study officials:
affiliation: Samsung Medical Center -Seoul
name: Jeong-yi Kwon, M.D., Ph.D.
role: STUDY_CHAIR
References: