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

Medy-Tox0 sites120 target enrollmentSeptember 6, 2013

ConditionsSpasticity, Muscle

InterventionsMeditoxin

DrugsMeditoxin

Overview

Phase: Phase 4
Intervention: Meditoxin
Conditions: Spasticity, Muscle
Sponsor: Medy-Tox
Enrollment: 120
Primary Endpoint: Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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".

Registry

clinicaltrials.gov

Start Date

September 6, 2013

End Date

March 31, 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Medy-Tox

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female over 20 years.
•Subjects that was diagnosed with stroke at least 1 month before participating in the clinical trial.
•Subjects with MAS score of ≥2 for local muscle spasticity of wrist flexor.

Exclusion Criteria

•Subjects with generalized neuromuscular junction disorder (ex: myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, etc.).
•Subjects with fixed joint, muscle contracture, or atrophy in the treatment area.
•Subjects with botulinum toxin treatment within 3 months before administration of the investigational product.
•Known immunization or hypersensitivity to any botulinum toxin preparations.
•Subjects who have recieved the following treatments within 4 weeks from screening: Muscle relaxants, Benzodiazepines, Aminoglycosides, Other antibiotics, Anticholinergics

Arms & Interventions

Meditoxin®

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

Intervention: Meditoxin

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

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