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

NCT05164003 | Completed Phase 1

• 1 other identifier: MT03-KR16MST907 (Phase1)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Modified Ashworth Scale of wrist flexor

  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)

  4 weeks

Secondary Outcomes (3)

• Modified Ashworth Scale of elbow and finger flexor

  4 weeks after the injection

• Modified Ashworth Scale of wrist, elbow and finger flexor

  8 and 12 weeks after the injection

• Modified Ashworth Scale of wrist, elbow and finger flexor

  4, 8 and 12 weeks after the injection

Study Arms (2)

CORETOX®

EXPERIMENTAL

Drug: CORETOX®

BOTOX®

ACTIVE COMPARATOR

Drug: BOTOX®

Interventions

CORETOX® DRUG

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

CORETOX®

BOTOX® DRUG

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

BOTOX®

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 19 years
• months since the last stroke
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Muscle Spasticity

Interventions

coretox; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: December 20, 2021
• Study Start: July 17, 2017
• Primary Completion: September 29, 2017
• Study Completion: September 29, 2017
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

KR (1)