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

Primary Purpose

Muscle Spasticity

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

CORETOX®

BOTOX®

About this trial

This is an interventional treatment trial for Muscle Spasticity

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CORETOX®

BOTOX®

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT03289702

First Posted

September 19, 2017

Last Updated

December 5, 2021

Sponsor

Medy-Tox

1. Study Identification

Unique Protocol Identification Number

NCT03289702

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

November 13, 2017 (Actual)

Primary Completion Date

June 30, 2018 (Actual)

Study Completion Date

November 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medy-Tox

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle Spasticity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

220 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CORETOX®

Arm Type

Experimental

Arm Title

BOTOX®

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

CORETOX®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

BOTOX®

Intervention Description

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

Primary Outcome Measure Information:

Title

MAS(Modified Ashworth Scale)of wrist flexor

Description

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

MAS(modified Ashworth Score)of elbow and finger flexor

Description

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

Time Frame

4 weeks after injection

Title

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

Description

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

Title

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

Description

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

Time Frame

4, 8, 12 weeks after injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32497599

Citation

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.

Results Reference

derived

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

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