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Phase III Clinical Trial of "Botulax®" to Treat Children With Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01787344
Recruitment Status : Completed
First Posted : February 8, 2013
Last Update Posted : May 4, 2015
Sponsor:
Information provided by (Responsible Party):
Hugel

Tracking Information
First Submitted Date  ICMJE February 5, 2013
First Posted Date  ICMJE February 8, 2013
Last Update Posted Date May 4, 2015
Study Start Date  ICMJE March 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
Rate of patients with an improvement more than two grade in Physician's Rating Scale score. [ Time Frame: at 12 weeks post-injection ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
  • 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, Gross Motor Function Measure 88, 66 and Modified Tardieu Scale(Ankle DF), compare to baseline. [ Time Frame: at 6, 12 and 24 weeks post-injection ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Clinical Trial of "Botulax®" to Treat Children With Cerebral Palsy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Other Infantile Cerebral Palsy
Intervention  ICMJE
  • Drug: 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(Botulax®)
    Single administration, 4units/kg body weight dose in patients with hemiplegia,6units/kg body weight dose in patients with diplegia, Maximum dosage 200units
Study Arms  ICMJE
  • Experimental: Botulinum toxin type A (Botulax®)
    Botulinum toxin type A (Botulax®)
    Intervention: Drug: Botulinum toxin type A(Botulax®)
  • Active Comparator: Botulinum toxin type A(Botox®)
    Botulinum toxin type A(Botox®)
    Intervention: Drug: Botulinum Toxin Type A(Botox®)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2013)
144
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01787344
Other Study ID Numbers  ICMJE HG-11-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hugel
Study Sponsor  ICMJE Hugel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jeong-yi Kwon, M.D., Ph.D. Samsung Medical Center -Seoul
PRS Account Hugel
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP