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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01787344
First Posted: February 8, 2013
Last Update Posted: May 4, 2015
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.
Information provided by (Responsible Party):
Hugel
  Purpose
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.

Condition Intervention Phase
Other Infantile Cerebral Palsy Drug: Botulinum Toxin Type A(Botox®) Drug: Botulinum toxin type A(Botulax®) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hugel:

Primary Outcome Measures:
  • Rate of patients with an improvement more than two grade in Physician's Rating Scale score. [ Time Frame: at 12 weeks post-injection ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 144
Study Start Date: March 2012
Study Completion Date: August 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum toxin type A (Botulax®)
Botulinum toxin type A (Botulax®)
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
Active Comparator: Botulinum toxin type A(Botox®)
Botulinum toxin type A(Botox®)
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787344


Locations
Korea, Republic of
St. Vincent's hospital
Suwon, Kyunggi, 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
Sponsors and Collaborators
Hugel
Investigators
Study Chair: Jeong-yi Kwon, M.D., Ph.D. Samsung Medical Center -Seoul
  More Information

Responsible Party: Hugel
ClinicalTrials.gov Identifier: NCT01787344     History of Changes
Other Study ID Numbers: HG-11-02
First Submitted: February 5, 2013
First Posted: February 8, 2013
Last Update Posted: May 4, 2015
Last Verified: April 2015

Keywords provided by Hugel:
Other Infantile Cerebral Palsy

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents