Muscle Spasticity
Conditions
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.
Interventions
DRUGBotulinum 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
Sponsors
Medy-Tox
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
South Korea
Outcome results
None listed