Phase III Clinical Trial of "Botulax®" to Treat Children With Cerebral Palsy
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
1 other identifier
interventional
144
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2012
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 5, 2013
CompletedFirst Posted
Study publicly available on registry
February 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedMay 4, 2015
April 1, 2015
2.3 years
February 5, 2013
May 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of patients with an improvement more than two grade in Physician's Rating Scale score.
at 12 weeks post-injection
Secondary Outcomes (4)
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
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
Study Arms (2)
Botulinum toxin type A (Botulax®)
EXPERIMENTALBotulinum toxin type A (Botulax®)
Botulinum toxin type A(Botox®)
ACTIVE COMPARATORBotulinum toxin type A(Botox®)
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hugellead
Study Sites (6)
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
Samsung medical center - Seoul
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's hospital
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jeong-yi Kwon, M.D., Ph.D.
Samsung Medical Center -Seoul
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2013
First Posted
February 8, 2013
Study Start
March 1, 2012
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
May 4, 2015
Record last verified: 2015-04