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CompletedNCT03289702Updated Dec 7, 2021

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

A Phase 3 interventional study of CORETOX® and BOTOX® in Muscle Spasticity, sponsored by Medy-Tox. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-12-07.

Sponsored by Medy-Tox · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Muscle Spasticity

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03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
220 participants (actual)

Study arms

  • Experimental
    CORETOX®

    Drug: CORETOX®

  • Active comparator
    BOTOX®

    Drug: BOTOX®

Interventions

  • DrugCORETOX®

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

  • DrugBOTOX®

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

05

What researchers measure

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)

    Time frame: 4 weeks

Secondary outcomes

  1. MAS(modified Ashworth Score)of elbow and finger flexor

    Change from baseline at week 4 for elbow flexor and finger flexor muscle tone as measured on MAS

    Time frame: 4 weeks after injection

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

    Change from baseline at week 8, 12 for wrist flexor, elbow flexor and finger flexor muscle tone as measured on MAS

    Time frame: 8, 12 weeks after injection

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

    A treatment response is defined as 1-point improvement on the MAS of injection site

    Time frame: 4, 8, 12 weeks after injection

06

Study locations

1 site
  • Asan Medical Center
    Seoul, Korea, Republic of
07

References and documents

Publications

  • 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. PubMed 32497599 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03289702
Lead sponsor
Medy-Tox
Responsible party
Sponsor
First posted
Sep 21, 2017
Start date
Nov 13, 2017
Primary completion
Jun 30, 2018
Completion
Nov 9, 2018
Last update
Dec 7, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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