Muscle Spasticity
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of CORETOX® in the treatment of post-stroke upper limb spasticity
Interventions
DRUGBOTOX®
Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.
DRUGCORETOX®
Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.
Sponsors
Medy-Tox
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients ≥ 19 years * ≥ 6 months since the last stroke * ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of elbow flexor and finger flexor as measured on MAS(0 to 4) * Informed consent has been obtained
Exclusion criteria
* Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis * History(within 4 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection or surgery in the target limb * History(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb * Fixed joint/muscle contracture * Severe atrophy * Concurrent treatment with an intrathecal baclofen * Patients who have bleeding tendency or taking anti-coagulant * Dysphagia and Breathing Difficulties * History(within 4 months of screening visit) Planned(during study period) treatment with Botulinum Toxin * Known allergy or sensitivity to study medication or its components * Concurrent or planed Muscle relaxants and/or benzodiazepine medication If patient has taken these medication stable from one month before screening and no treatment changes are not planned during the study, participation is allowed. * Current Physical, occupational, Splinting therapy These therapy regimens will be permitted if they have been stable in the one month before screening; no treatment and no changes are planned during the study. * Patient who are participating in other clinical trials at the screening * Females who are pregnant, breastfeeding, or planning a pregnancy during the study period, or female of childbearing potential, not using a reliable means of contraception. * Patients who are not eligible for this study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAS(Modified Ashworth Scale)of wrist flexor | 4 weeks | Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MAS(modified Ashworth Score)of elbow and finger flexor | 4 weeks after injection | Change from baseline at week 4 for elbow flexor and finger flexor muscle tone as measured on MAS |
| MAS(modified Ashworth Score)of wrist, elbow and finger flexor | 8, 12 weeks after injection | Change from baseline at week 8, 12 for wrist flexor, elbow flexor and finger flexor muscle tone as measured on MAS |
| Percentage of treatment responder at week 4, 8, 12 after injection | 4, 8, 12 weeks after injection | A treatment response is defined as 1-point improvement on the MAS of injection site |
Countries
South Korea
Outcome results
None listed