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

Muscle Spasticity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256021
• Other study ID #: MT_PRT_CP02
• Status: Completed
• Phase: Phase 4
• Start date: August 2010
• Est. completion date: May 2011

Study information

• Verified date: March 2019
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: May 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National Universtiy Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks
Secondary	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	12 weeks
Secondary	Mean change from baseline in PROM(Passive Range of Motion of ankle) at ankle dorsiflexion from baseline to week 4, 12		4, 12 Weeks
Secondary	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).	4, 12 weeks
Secondary	Improvement in Global Assessment assessed by caregiver/patient		4, 12 weeks