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

Phase 4

Completed

• Conditions: Muscle Spasticity
• Interventions: Drug: Botulinum Toxin Type A

• Registration Number: NCT01256021
• Lead Sponsor: Medy-Tox

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-07
• Study First Posted: 2010-12-08
• Primary Completion: 2011-02
• Study Completion: 2011-05
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group 1	Botulinum Toxin Type A	Meditoxin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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).
Mean change from baseline in PROM(Passive Range of Motion of ankle) at ankle dorsiflexion from baseline to week 4, 12	4, 12 Weeks
Improvement in Global Assessment assessed by caregiver/patient	4, 12 weeks

Trial Locations

Locations (4)

Seoul National Universtiy Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Yonsei University Severance Hospital; 🇰🇷 Seoul, Korea, Republic of