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Completed

NCT Number: NCT05164003

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

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

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

CORETOX®

Drug

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

Botox®

Drug

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

Primary outcomes

  1. Modified Ashworth Scale of wrist flexor

    Time frame: 4 weeks

    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)

Secondary outcomes

  1. Modified Ashworth Scale of elbow and finger flexor

    Time frame: 4 weeks after the injection

    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)

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

    Time frame: 8 and 12 weeks after the injection

    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)

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

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

    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)

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

A Randomized, Double-blind, Active Drug Controlled, Multi-Center, Phase I/III Clinical Trial to Evaluate the Efficacy and Safety of CORETOX® in Treatment of Post Stroke Upper Limb Spasticity

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 20, 2021
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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