CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase3)

• CORETOX® (Drug): Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.
• BOTOX® (Drug): Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.

Primary outcomes

• 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 outcomes

• 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

Sex: All, ages: 19 Years to any

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.

• Results publication: Lee J, Chun MH, Ko YJ, Lee SU, Kim DY, Paik NJ, Kwon BS, Park YG. Efficacy and Safety of MT10107 (Coretox) in Poststroke Upper Limb Spasticity Treatment: A Randomized, Double-Blind, Active Drug-Controlled, Multicenter, Phase III Clinical Trial. Arch Phys Med Rehabil. 2020 Sep;101(9):1485-1496. doi: 10.1016/j.apmr.2020.03.025. Epub 2020 Jun 1. PMID 32497599