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

Sponsor

Medy-Tox (Industry)

Overall Status

Completed

CT.gov ID

NCT01256021

Collaborator

(none)

212

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

5.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Spasticity	Drug: Botulinum Toxin Type A	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

212 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group 1 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 Names: Neuronox®, Siax®

Arm

Intervention/Treatment

Experimental: Treatment Group 1

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 Names:

Neuronox®, Siax®

Outcome Measures

Primary Outcome Measures

Mean change from baseline in MAS score from baseline to week 4 [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 Outcome Measures

Mean change from baseline in MAS score from baseline to week 12 [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
Mean change from baseline in PROM(Passive Range of Motion of ankle) at ankle dorsiflexion from baseline to week 4, 12 [4, 12 Weeks]
Mean change from baseline in VAS(Visual Analogue Scale)assessed by caregiver/patient from baseline to week4 [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).
Improvement in Global Assessment assessed by caregiver/patient [4, 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam	Korea, Republic of
2	Seoul National Universtiy Hospital	Seoul	Korea, Republic of	110-744
3	Asan Medical Center	Seoul	Korea, Republic of
4	Yonsei University Severance Hospital	Seoul	Korea, Republic of