CORETOX® in Treatment of Post Stroke Upper Limb Spasticity

• Status: Completed
• Trial end date: 2018-11-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of CORETOX® in the treatment of Post stroke upper limb spasticity

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medy-Tox

Criteria

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.