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

Phase 3

Completed

• Conditions: Muscle Spasticity
• Interventions: Drug: CORETOX®; Drug: BOTOX®

• Registration Number: NCT03289702
• Lead Sponsor: Medy-Tox

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-21
• Study Start: 2017-11-13
• Primary Completion: 2018-06-30
• Study Completion: 2018-11-09
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-05
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CORETOX®	CORETOX®	-
BOTOX®	BOTOX®	-

Primary Outcome Measures

Name	Time	Method
MAS(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)

Secondary Outcome Measures

Name	Time	Method
MAS(modified Ashworth Score)of elbow and finger flexor	4 weeks after injection	Change from baseline at week 4 for elbow flexor and finger flexor muscle tone as measured on MAS
Percentage of treatment responder at week 4, 8, 12 after injection	4, 8, 12 weeks after injection	A treatment response is defined as 1-point improvement on the MAS of injection site
MAS(modified Ashworth Score)of wrist, elbow and finger flexor	8, 12 weeks after injection	Change from baseline at week 8, 12 for wrist flexor, elbow flexor and finger flexor muscle tone as measured on MAS

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of