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
NCT number | NCT01256021 |
Other study ID # | MT_PRT_CP02 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | August 2010 |
Est. completion date | May 2011 |
Verified date | March 2019 |
Source | Medy-Tox |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of children with cerebral palsy.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Medy-Tox |
Korea, Republic of,
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 |
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