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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-06

Study Completion Date

2015-03-31

Brief Summary

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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".

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Detailed Description

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Conditions

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Spasticity, Muscle

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Meditoxin®

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

Group Type EXPERIMENTAL

Meditoxin

Intervention Type DRUG

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

Interventions

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Meditoxin

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

Intervention Type DRUG

Other Intervention Names

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Neuronox®

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No