A Phase 3 interventional study of CORETOX® and BOTOX® in Muscle Spasticity, sponsored by Medy-Tox. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-12-07.
Sponsored by Medy-Tox · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of CORETOX® in the treatment of post-stroke upper limb spasticity
Exclusion Criteria:
Drug: CORETOX®
Drug: BOTOX®
Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.
Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.
MAS(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)
Time frame: 4 weeks
MAS(modified Ashworth Score)of elbow and finger flexor
Change from baseline at week 4 for elbow flexor and finger flexor muscle tone as measured on MAS
Time frame: 4 weeks after injection
MAS(modified Ashworth Score)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
Time frame: 8, 12 weeks after injection
Percentage of treatment responder at week 4, 8, 12 after injection
A treatment response is defined as 1-point improvement on the MAS of injection site
Time frame: 4, 8, 12 weeks after injection
Plan to share: Undecided
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Medy-Tox