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

NCT ID: NCT05164003

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-17
• Study Completion Date: 2017-09-29

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

Conditions

Muscle Spasticity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CORETOX®

Group Type: EXPERIMENTAL

CORETOX®

Intervention Type: DRUG

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

BOTOX®

Group Type: ACTIVE_COMPARATOR

BOTOX®

Intervention Type: DRUG

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

Interventions

CORETOX®

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

Intervention Type: DRUG

BOTOX®

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medy-Tox

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

MT03-KR16MST907 (Phase1)

Identifier Type: -

Identifier Source: org_study_id