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

• Status: Completed
• Trial end date: 2015-03-31
• Target enrollment: 0
• Participant gender: Female

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".

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medy-Tox
• Treatments: Botulinum Toxins, Type A

Criteria

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