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Completed

NCT Number: NCT01256021

The Efficacy and Safety of MEDITOXIN® in Children With Cerebral Palsy

The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of children with cerebral palsy.

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Key information

Conditions

Muscle Spasticity Muscle Hypertonia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital, Seongnam, South Korea

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About this study

The allocated subject is injected Meditoxin® 4U/kg body weight(for patients with hemiplegia) or 6U/kg body weight(for patients with diplegia)in the affected gastrocnemius muscle for the treatment of patients who suffer Equinus Foot Deformity with pediatric cerebral palsy due to spasticity.

The efficacy and safety are evaluated for 12weeks through 3 follow up visits.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pediatric patients aged between 2 and 18 years with diagnosis of spastic cerebral palsy
  • Patients with toe-walking due to peroneal muscle spasticity (patients with equinus foot deformity due to spasticity)
  • Patients who voluntarily consent to participate in this study and whose legally acceptable representative has signed the informed consent form (if the patient is able to write, his/her signature should be also obtained).

Exclusion criteria

  • Patients who had previously received botulinum toxin within 3 months prior to the study entry
  • Patients with known hypersensitivity to botulinum toxin
  • Patients who requires legs, feet or ankle surgery at present
  • Patients with severe athetoid movement
  • Patients who is participating in other investigational study at present
  • Patients, by the investigator's discretion, who are not suitable for this study.

Treatment and study plan

Botulinum Toxin Type A

Drug

1 time, gastrocnemius muscles injection, dose of 4U/kg body weight in patients with hemiplegia, dose of 6U/kg body weight in patients with diplegia, Maximum dosage 200U

Other names: Neuronox®, Siax®

Primary outcomes

  1. Mean change from baseline in MAS score from baseline to week 4

    Time frame: 4 weeks

    The investigator assessed MAS score using a 5-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) The "+1" (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 2

Secondary outcomes

  1. Mean change from baseline in MAS score from baseline to week 12

    Time frame: 12 weeks

    The investigator assessed MAS score using a 5-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) The "+1" (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 2

  2. Mean change from baseline in PROM(Passive Range of Motion of ankle) at ankle dorsiflexion from baseline to week 4, 12

    Time frame: 4, 12 Weeks

  3. Mean change from baseline in VAS(Visual Analogue Scale)assessed by caregiver/patient from baseline to week4

    Time frame: 4, 12 weeks

    Individual goals of treatment were chosen one among pain, ease of care, standing, walking. The VAS used in this study is a straight 10cm horizontal line with anchor points of very satisfied (score 0)and very dissatisfied (score 10).

  4. Improvement in Global Assessment assessed by caregiver/patient

    Time frame: 4, 12 weeks

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Safety and Efficacy of MEDITOXIN® in Children With Cerebral Palsy

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 8, 2010
Registry last updated
Mar 27, 2019

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.

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