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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Medy-Tox.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medy-Tox
ClinicalTrials.gov Identifier:
NCT01256021
First received: December 6, 2010
Last updated: December 7, 2010
Last verified: August 2010
  Purpose

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


Condition Intervention Phase
Muscle Spasticity
Drug: Botulinum Toxin Type A
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Safety and Efficacy of MEDITOXIN® in Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Medy-Tox:

Primary Outcome Measures:
  • Mean change from baseline in MAS score from baseline to week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Mean change from baseline in MAS score from baseline to week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
  • Mean change from baseline in VAS(Visual Analogue Scale)assessed by caregiver/patient from baseline to week4 [ Time Frame: 4, 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Improvement in Global Assessment assessed by caregiver/patient [ Time Frame: 4, 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 212
Study Start Date: August 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum Toxin Type A(Meditoxin®) Drug: Botulinum Toxin Type A
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 Name: Neuronox®, Siax®

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256021

Locations
Korea, Republic of
Yonsei University Severance Hospital Completed
Seoul, Korea, Republic of
Seoul National Universtiy Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Moon Suk Bang, Ph D    +82-2-2072-2560    msbang@snu.ac.kr   
Principal Investigator: Moon Suk Bang, Ph D         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: In Young Sung, Ph D       iysung@amc.seoul.kr   
Principal Investigator: In Young Sung, Ph D         
Seoul National University Bundang Hospital Recruiting
Sungnam, Korea, Republic of
Contact: Hyung Ik Shin, Ph D    +82-31-787-7733    hyungik1@snu.ac.kr   
Principal Investigator: Hyoung Ik Shin, Ph D         
Sponsors and Collaborators
Medy-Tox
Investigators
Principal Investigator: Eun S Park, Ph D Yonsei University Severance Hospital
  More Information

No publications provided

Responsible Party: Yunjung Joo / CRA, Medytox
ClinicalTrials.gov Identifier: NCT01256021     History of Changes
Other Study ID Numbers: MT_PRT_CP02
Study First Received: December 6, 2010
Last Updated: December 7, 2010
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Cerebral Palsy
Muscle Spasticity
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014