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

Phase 1

Completed

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

• Registration Number: NCT05164003
• Lead Sponsor: Medy-Tox

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-17
• Primary Completion: 2017-09-29
• Study Completion: 2017-09-29
• Status Verified: 2021-12
• Study First Submitted: 2021-12-05
• Study First Submitted QC: 2021-12-05
• Study First Posted: 2021-12-20
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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
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

Name	Time	Method
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	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)

Trial Locations

Locations (1)

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