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OpenTrials
Completed

NCT Number: NCT01787344

Phase III Clinical Trial of "Botulax®" to Treat 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.

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Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. Vincent's hospital, Suwon, Kyunggi, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Rate of patients with an improvement more than two grade in Physician's Rating Scale score.

    Time frame: at 12 weeks post-injection

Secondary outcomes

  1. 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

  2. Rate of change in Passive range of motion, compare to baseline.

    Time frame: at 6, 12 and 24 weeks post-injection

  3. Rate of change in Gross Motor Function Measure 88, 66, compare to baseline.

    Time frame: at 6, 12 and 24 weeks post-injection

  4. Rate of change in Modified Tardieu Scale(Ankle DF), compare to baseline.

    Time frame: at 6, 12 and 24 weeks post-injection

Sponsors and collaborators

Lead sponsor

Hugel

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 8, 2013
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.