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

Medytox

Status and phase: Completed; Phase 4

Conditions: Spasticity, Muscle

Treatments: Drug: Meditoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03908580

MT_PRT_ST02

Details and patient eligibility

About

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".

Enrollment: 120 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Meditoxin®

Experimental group

Description:

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

Treatment:

Drug: Meditoxin