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

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 Overview

• Status: Completed
• Conditions: Other Infantile Cerebral Palsy
• Intervention / Treatment: Drug: Botulinum toxin type A(Botulax®); Drug: Botulinum Toxin Type A(Botox®)

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Changwon, Korea, Republic of
    • Samsung medical center - Changwon
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of
    • Catholic university of Korea, Daejeon St. Mary's hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center - Seoul
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Kyunggi
    • Suwon, Kyunggi, Korea, Republic of
      • St. Vincent's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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®)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of patients with an improvement more than two grade in Physician's Rating Scale score.	at 12 weeks post-injection

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hugel
• Investigators: Study Chair: Jeong-yi Kwon, M.D., Ph.D., Samsung Medical Center -Seoul

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: February 5, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (Estimate): February 8, 2013

Study Record Updates

• Last Update Posted (Estimate): May 4, 2015
• Last Update Submitted That Met QC Criteria: May 1, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Other Infantile Cerebral Palsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: HG-11-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No