CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase1)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and pharmacodynamic of CORETOX® in the treatment of post-stroke upper limb spasticity

Official Title
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A Randomized, Double-blind, Active Drug Controlled, Multi-Center, Phase I/III Clinical Trial to Evaluate the Efficacy and Safety of CORETOX® in Treatment of Post Stroke Upper Limb Spasticity

Conditions
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Muscle Spasticity

Intervention / Treatment
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* Drug: CORETOX®
* Drug: BOTOX®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CORETOX®<br> | Drug: CORETOX®<br>* Up to a total of 360U of the IP was allowed to be injected at three flexors; wrist, elbow and finger.<br>|
| Active Comparator: BOTOX®<br> | Drug: BOTOX®<br>* Up to a total of 360U of the comparator was allowed to be injected at three flexors; wrist, elbow and finger.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 4, 8 and 12 weeks after the injection |