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

Sponsor

Medy-Tox (Industry)

Overall Status

Completed

CT.gov ID

NCT05164003

Collaborator

(none)

Enrollment

Location

Arms

2.4

Actual Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Muscle Spasticity	Drug: CORETOX® Drug: BOTOX®	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 17, 2017

Actual Primary Completion Date :

Sep 29, 2017

Actual Study Completion Date :

Sep 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CORETOX®	Drug: CORETOX® Up to a total of 360U of the IP was allowed to be injected at three flexors; wrist, elbow and finger.
Active Comparator: BOTOX®	Drug: BOTOX® Up to a total of 360U of the comparator was allowed to be injected at three flexors; wrist, elbow and finger.

Arm

Intervention/Treatment

Experimental: CORETOX®

Drug: CORETOX®

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

Active Comparator: BOTOX®

Drug: BOTOX®

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

Outcome Measures

Primary Outcome Measures

Modified Ashworth Scale of wrist flexor [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 Outcome Measures

Modified Ashworth Scale of elbow and finger flexor [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)
Modified Ashworth Scale of wrist, elbow and finger flexor [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)
Modified Ashworth Scale of wrist, elbow and finger flexor [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Medy-Tox

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medy-Tox

ClinicalTrials.gov Identifier:

NCT05164003

Other Study ID Numbers:

MT03-KR16MST907 (Phase1)

First Posted:

Dec 20, 2021

Last Update Posted:

Jan 11, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Muscle Spasticity

Study Results

No Results Posted as of Jan 11, 2022