MEDITOXIN® Treatment in Subjects With Post-Stroke Upper Limb Spasticity

Medy-Tox120 enrolled

Overview

This study is "A Prospective, Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Treatment of Post Stroke Upper Limb Spasticity".

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Spasticity, Muscle

Interventions

MeditoxinDRUG

Meditoxin® (Botulinum toxin type A) was injected up to 360 U.

Eligibility

Sex: FEMALEMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female over 20 years. 2. Subjects that was diagnosed with stroke at least 1 month before participating in the clinical trial. 3. Subjects with MAS score of ≥2 for local muscle spasticity of wrist flexor. Exclusion Criteria: 1. Subjects with generalized neuromuscular junction disorder (ex: myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, etc.). 2. Subjects with fixed joint, muscle contracture, or atrophy in the treatment area. 3. Subjects with botulinum toxin treatment within 3 months before administration of the investigational product. 4. Known immunization or hypersensitivity to any botulinum toxin preparations. 5. Subjects who have recieved the following treatments within 4 weeks from screening: Muscle relaxants, Benzodiazepines, Aminoglycosides, Other antibiotics, Anticholinergics

Outcomes

Primary Outcomes

Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor

Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of wrist flexor in subjects with post stroke upper limb spasticity at week 4 after administration compared to baseline.

Time frame: 4 weeks

Secondary Outcomes

Change in muscle tone determined by MAS (Modified Ashworth Scale) of elbow flexor and finger flexor

Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of elbow flexor and finger flexor at week 4 and 16 after administration compared to baseline, and at 4 weeks after re-administration compared to the time of re-visit.

Time frame: 4 weeks, 16 weeks, and 4 weeks after re-visit

Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor

Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of wrist flexor at week 16 after administration compared to baseline, and at 4 weeks after re-administration compared to the time of re-visit.

Time frame: 16 weeks, and 4 weeks after re-visit

The effective rate of wrist flexor, elbow flexor, and finger flexor

The effective rate of wrist flexor, elbow flexor, and finger flexor at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit, defining the muscle with MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) score of ≥1 among the wrist flexor, elbow flexor, and finger flexor muscles as responders when the MAS is reduced by 1 score compared to baseline (week 0).

Time frame: 4 weeks, 16 weeks, and 4 weeks after re-visit

Data from ClinicalTrials.gov

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