CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase3)

NCT03289702 | Completed Phase 3

• 1 other identifier: MT03-KR16MST907 (Phase3)
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Conditions

Muscle Spasticity

Outcome Measures

Primary Outcomes (1)

• MAS(Modified Ashworth Scale)of wrist flexor

  Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale)

  4 weeks

Secondary Outcomes (3)

• MAS(modified Ashworth Score)of elbow and finger flexor

  4 weeks after injection

• MAS(modified Ashworth Score)of wrist, elbow and finger flexor

  8, 12 weeks after injection

• Percentage of treatment responder at week 4, 8, 12 after injection

  4, 8, 12 weeks after injection

Study Arms (2)

CORETOX®

EXPERIMENTAL

Drug: CORETOX®

BOTOX®

ACTIVE COMPARATOR

Drug: BOTOX®

Interventions

CORETOX® DRUG

Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.

CORETOX®

BOTOX® DRUG

Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.

BOTOX®

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32497599 DERIVED

MeSH Terms

Conditions

Muscle Spasticity

Interventions

coretox; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 21, 2017
• Study Start: November 13, 2017
• Primary Completion: June 30, 2018
• Study Completion: November 9, 2018
• Last Updated: December 7, 2021

Record last verified: 2021-12

Locations

KR (1)