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

• Sponsor: Medy-Tox (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03289702
• Collaborator: (none)
• Enrollment: 220
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.9
• Patients Per Site Per Month: 18.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Muscle Spasticity	Drug: CORETOX®; Drug: BOTOX®	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 220 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: Nov 13, 2017
• Actual Primary Completion Date: Jun 30, 2018
• Actual Study Completion Date: Nov 9, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CORETOX®	Drug: CORETOX®; Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.
Active Comparator: BOTOX®	Drug: BOTOX®; Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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: NCT03289702
• Other Study ID Numbers: MT03-KR16MST907 (Phase3)
• First Posted: Sep 21, 2017
• Last Update Posted: Dec 7, 2021
• 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: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Muscle Spasticity

Study Results

No Results Posted as of Dec 7, 2021