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

Medytox

Status and phase

Completed

Phase 1

Conditions

Muscle Spasticity

Treatments

Drug: CORETOX®

Drug: BOTOX®

Study type

Interventional

Funder types

Industry

Identifiers

NCT05164003

MT03-KR16MST907 (Phase1)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and pharmacodynamic of CORETOX® in the treatment of post-stroke upper limb spasticity

Enrollment

30 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.