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

NCT03908580 | Completed Phase 4

• 1 other identifier: MT_PRT_ST02
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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".

Conditions

Spasticity, Muscle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (1)

Meditoxin®

EXPERIMENTAL

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

Drug: Meditoxin

Interventions

Meditoxin DRUG

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

Also known as: Neuronox®

Meditoxin®

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medy-Tox: lead

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 9, 2019
• Study Start: September 6, 2013
• Primary Completion: October 31, 2014
• Study Completion: March 31, 2015
• Last Updated: April 9, 2019

Record last verified: 2019-04