Other Infantile Cerebral PalsyPhase 3NCT01787344
Phase III Clinical Trial of "Botulax®" to Treat Children With Cerebral Palsy
A Phase 3 study testing Botulinum Toxin Type A(Botox®) and Botulinum toxin type A(Botulax®) in people with Other Infantile Cerebral Palsy, run by Hugel at 6 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Other Infantile Cerebral Palsy
- What is being tested?
- Botulinum Toxin Type A(Botox®) and Botulinum toxin type A(Botulax®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Mar 2012to Aug 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Samsung medical center - Changwon
Changwon
Keimyung University Dongsan Medical Center
Daegu
Catholic university of Korea, Daejeon St. Mary's hospital
Daejeon
Samsung medical center - Seoul
Seoul
The Catholic University of Korea, Seoul St. Mary's hospital
Seoul
St. Vincent's hospital
Suwon, Kyunggi
About this study
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
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.
- Conditions
- Other Infantile Cerebral Palsy
- Being tested
- Botulinum Toxin Type A(Botox®), Botulinum toxin type A(Botulax®)
- Keywords
- Other Infantile Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A (Botulax®) | Experimental | Botulinum toxin type A (Botulax®) Receives: Drug: Botulinum toxin type A(Botulax®) |
| Botulinum toxin type A(Botox®) | Active comparator | Botulinum toxin type A(Botox®) Receives: Drug: Botulinum Toxin Type A(Botox®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with an improvement more than two grade in Physician's Rating Scale score.
Measured: 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.
Measured: at 6 and 24weeks post-injection
Rate of change in Passive range of motion, compare to baseline.
Measured: at 6, 12 and 24 weeks post-injection
Rate of change in Gross Motor Function Measure 88, 66, compare to baseline.
Measured: at 6, 12 and 24 weeks post-injection
Rate of change in Modified Tardieu Scale(Ankle DF), compare to baseline.
Measured: at 6, 12 and 24 weeks post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startMar 2012
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Infantile Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeong-yi Kwon, M.D., Ph.D., Study chair, Samsung Medical Center -Seoul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787344
- Sponsor's protocol ID
- HG-11-02
- Status last verified
- Apr 2015
- First submitted
- 5 Feb 2013
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01787344
- Acronym / sponsor ID
- HG-11-02
- Conditions
- Other Infantile Cerebral Palsy
- Keywords
- Other Infantile Cerebral Palsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- HugelIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin type A (Botulax®) | Experimental | Drug: Botulinum toxin type A(Botulax®)Botulinum toxin type A (Botulax®) |
| Botulinum toxin type A(Botox®) | Active comparator | Drug: Botulinum Toxin Type A(Botox®)Botulinum toxin type A(Botox®) |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type A(Botox®)Single administration, 4units/kg body weight dose in patients with hemiplegia, 6units/kg body weight dose in patients with diplegia, Maximum dosage 200units | Drug | Botulinum toxin type A(Botox®) |
| Botulinum toxin type A(Botulax®)Single administration, 4units/kg body weight dose in patients with hemiplegia,6units/kg body weight dose in patients with diplegia, Maximum dosage 200units | Drug | Botulinum toxin type A (Botulax®) |
Primary outcome
Rate of patients with an improvement more than two grade in Physician's Rating Scale score.
Time frame: at 12 weeks post-injection
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong-yi Kwon, M.D., Ph.D. study chair
Samsung Medical Center -Seoul
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin Type A(Botox®) and Botulinum toxin type A(Botulax®) in people with Other Infantile Cerebral Palsy, run by Hugel at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with an improvement more than two grade in Physician's Rating Scale score. (time frame: at 12 weeks post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.