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

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

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 Overview

• Status: Completed
• Conditions: Spasticity, Muscle
• Intervention / Treatment: Drug: Meditoxin

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meditoxin®; Botulinum toxin type A was intramuscularly injected up to 360U and up to 4 sites, depending on the muscle size.	Drug: Meditoxin; Meditoxin® (Botulinum toxin type A) was injected up to 360 U.; Other Names: Neuronox®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	4 weeks, 16 weeks, and 4 weeks after re-visit
Change in DAS (Disability Assessment Scale) score	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.	4 weeks, 16 weeks, and 4 weeks after re-visit
Change in QOL (SF-36v2; Quality of Life) score	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.	4 weeks, 16 weeks, and 4 weeks after re-visit
Subject's or caregiver's global assessment	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.	4 weeks, 16 weeks, and 4 weeks after re-visit
Number of participants with Adverse Events (AEs) to assess safety of investigational product.	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.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Medy-Tox

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2013
• Primary Completion (Actual): October 31, 2014
• Study Completion (Actual): March 31, 2015

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: April 7, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 7, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A
• Other Study ID Numbers: MT_PRT_ST02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No