CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase3)
NCT ID: NCT03289702
Last Updated: 2021-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
220 participants
INTERVENTIONAL
2017-11-13
2018-11-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CORETOX®
CORETOX®
Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.
BOTOX®
BOTOX®
Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.
Interventions
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CORETOX®
Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.
BOTOX®
Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.
Eligibility Criteria
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Inclusion Criteria
* ≥ 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
* 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.
19 Years
ALL
No
Sponsors
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Medy-Tox
INDUSTRY
Responsible Party
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Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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References
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Lee J, Chun MH, Ko YJ, Lee SU, Kim DY, Paik NJ, Kwon BS, Park YG. Efficacy and Safety of MT10107 (Coretox) in Poststroke Upper Limb Spasticity Treatment: A Randomized, Double-Blind, Active Drug-Controlled, Multicenter, Phase III Clinical Trial. Arch Phys Med Rehabil. 2020 Sep;101(9):1485-1496. doi: 10.1016/j.apmr.2020.03.025. Epub 2020 Jun 1.
Other Identifiers
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MT03-KR16MST907 (Phase3)
Identifier Type: -
Identifier Source: org_study_id