CORETOX® in Treatment of Post Stroke Upper Limb Spasticity


Phase 3 Results N/A

Eligibility Criteria

Inclusion Criteria

- Male or female patients ≥ 19 years
- ≥ 6 weeks since the last stroke
- ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 points 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 If these therapy regimens will be permitted if they has 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, breatfeeding,or planning a pregnancy during the study period, or female of childbearing potential, not using a reliable means of centraception.
- Patients who are not eligible for this study at the discretion of the investigator.