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CompletedNCT05164003Updated Jan 11, 2022

CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase1)

A Phase 1 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 2022-01-11.

Sponsored by Medy-Tox · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 4 months after the study started (first participant enrolled Jul 2017, registered Dec 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Muscle Spasticity

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03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 30 is below the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Medy-Tox is the lead sponsor of 48 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    CORETOX®

    Drug: CORETOX®

  • Active comparator
    BOTOX®

    Drug: BOTOX®

Interventions

  • DrugCORETOX®

    Up to a total of 360U of the IP was allowed to be injected at three flexors; wrist, elbow and finger.

  • DrugBOTOX®

    Up to a total of 360U of the comparator was allowed to be injected at three flexors; wrist, elbow and finger.

06

What researchers measure

Primary outcomes

  1. 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) Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)

    Time frame: 4 weeks

Secondary outcomes

  1. Modified Ashworth Scale of elbow and finger flexor

    Change from baseline at week 4 for elbow flexor and finger flexor muscle tone as measured on MAS Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)

    Time frame: 4 weeks after the injection

  2. Modified Ashworth Scale 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 Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)

    Time frame: 8 and 12 weeks after the injection

  3. Modified Ashworth Scale of wrist, elbow and finger flexor

    The responder rate of wrist, elbow, and finger flexor tone at week 4, 8 and 12 if the responder rate is defined as at least 1-point decrease in MAS score after IP administration. Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)

    Time frame: 4, 8 and 12 weeks after the injection

07

Study locations

1 site
  • Asan Medical Center
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05164003
Lead sponsor
Medy-Tox
Responsible party
Sponsor
First posted
Dec 20, 2021
Start date
Jul 17, 2017
Primary completion
Sep 29, 2017
Completion
Sep 29, 2017
Last update
Jan 11, 2022

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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