Status:
COMPLETED
CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase3)
Lead Sponsor:
Medy-Tox
Conditions:
Muscle Spasticity
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of CORETOX® in the treatment of post-stroke upper limb spasticity
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2018
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03289702
Start Date
November 13 2017
End Date
November 9 2018
Last Update
December 7 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asan Medical Center
Seoul, South Korea