Back to resultsThe Efficacy and Safety of MEDITOXIN® in Children With Cerebral Palsy
Primary Purpose
Muscle Spasticity
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Spasticity
Eligibility 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.
Sites / Locations
- Seoul National University Bundang Hospital
- Seoul National Universtiy Hospital
- Asan Medical Center
- Yonsei University Severance Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group 1
Arm Description
Meditoxin
Outcomes
Primary Outcome Measures
Mean change from baseline in MAS score from baseline to week 4
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
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
Mean change from baseline in VAS(Visual Analogue Scale)assessed by caregiver/patient from baseline to week4
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01256021
Brief Title
The Efficacy and Safety of MEDITOXIN® in Children With Cerebral Palsy
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medy-Tox
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of children with cerebral palsy.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Spasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
212 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group 1
Arm Type
Experimental
Arm Description
Meditoxin
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
Neuronox®, Siax®
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean change from baseline in MAS score from baseline to week 4
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Mean change from baseline in MAS score from baseline to week 12
Description
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
Time Frame
12 weeks
Title
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
Title
Mean change from baseline in VAS(Visual Analogue Scale)assessed by caregiver/patient from baseline to week4
Description
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).
Time Frame
4, 12 weeks
Title
Improvement in Global Assessment assessed by caregiver/patient
Time Frame
4, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eun S Park, Ph D
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Seoul National Universtiy Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of MEDITOXIN® in Children With Cerebral Palsy
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