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

Phase 4

Completed

• Conditions: Spasticity, Muscle
• Interventions: Drug: Meditoxin

• Registration Number: NCT03908580
• Lead Sponsor: Medy-Tox

Brief Summary

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".

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-06
• Primary Completion: 2014-10-31
• Study Completion: 2015-03-31
• Study First Submitted: 2019-03-26
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-07
• Last Update Submitted: 2019-04-07
• Study First Posted: 2019-04-09
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Meditoxin®	Meditoxin	Botulinum toxin type A was intramuscularly injected up to 360U and up to 4 sites, depending on the muscle size.

Primary Outcome Measures

Name	Time	Method
Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in muscle tone determined by MAS (Modified Ashworth Scale) of elbow flexor and finger flexor	4 weeks, 16 weeks, and 4 weeks after re-visit	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.
Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor	16 weeks, and 4 weeks after re-visit	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.
The effective rate of wrist flexor, elbow flexor, and finger flexor	4 weeks, 16 weeks, and 4 weeks after re-visit	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).
Change in DAS (Disability Assessment Scale) score	4 weeks, 16 weeks, and 4 weeks after re-visit	Change in score of goal assessment section in DAS (Disability Assessment Scale: Measures disability associated with upper limb spasticity in patients; score 0 to 3, 3 being the most severe disability) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.
Change in QOL (SF-36v2; Quality of Life) score	4 weeks, 16 weeks, and 4 weeks after re-visit	Change in score of Short Form 36 ver.2 (SF-36v2; Quality of Life, QOL: a questionnaire with 36 questions regarding general health change affecting patient's quality of life; score from 1 up to 5, from minimum to high impact on quality of life) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.
Subject's or caregiver's global assessment	4 weeks, 16 weeks, and 4 weeks after re-visit	Subject's or caregiver's global assessment (rating from -3 to +3 on the overall treatment effect, with +3 being very satisfied with treatment) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.
Number of participants with Adverse Events (AEs) to assess safety of investigational product.	Through study completion, an average of 1 year	Safety of IP assessed by the number of partiicipants with adverse events determined by MedDra ver 16.0 from enrollment to the end of study.