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

NCT01256021 | Completed Phase 4

• 1 other identifier: MT_PRT_CP02
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Muscle Spasticity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mean change from baseline in MAS score from baseline to week 12

  12 weeks

• 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

• Improvement in Global Assessment assessed by caregiver/patient

  4, 12 weeks

Study Arms (1)

Treatment Group 1

EXPERIMENTAL

Meditoxin

Drug: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type A DRUG

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

Also known as: Neuronox®, Siax®

Treatment Group 1

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (4)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Seoul National Universtiy Hospital

Seoul, 110-744, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Yonsei University Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Botulinum Toxins, Type A; 3-deoxyglycero-galacto-nonulosonic acid

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Eun S Park, Ph D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 8, 2010
• Study Start: August 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 27, 2019

Record last verified: 2019-03

Locations

KR (4)