Overview

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.