The purpose of this study is to evaluate the safety and pharmacodynamic of CORETOX® in the treatment of post-stroke upper limb spasticity
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Asan Medical Center
Seoul, South Korea
Modified Ashworth Scale of wrist flexor
Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS (Modified Ashworth Scale) Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)
Time frame: 4 weeks
Modified Ashworth Scale of elbow and finger flexor
Change from baseline at week 4 for elbow flexor and finger flexor muscle tone as measured on MAS Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)
Time frame: 4 weeks after the injection
Modified Ashworth Scale of wrist, elbow and finger flexor
Change from baseline at week 8, 12 for wrist flexor, elbow flexor and finger flexor muscle tone as measured on MAS Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)
Time frame: 8 and 12 weeks after the injection
Modified Ashworth Scale of wrist, elbow and finger flexor
The responder rate of wrist, elbow, and finger flexor tone at week 4, 8 and 12 if the responder rate is defined as at least 1-point decrease in MAS score after IP administration. Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)
Time frame: 4, 8 and 12 weeks after the injection
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