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Completed

NCT Number: NCT03908580

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

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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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meditoxin

Drug

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

Other names: Neuronox®

Primary outcomes

  1. 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

  1. Change in muscle tone determined by MAS (Modified Ashworth Scale) of elbow flexor and finger flexor

    Time frame: 4 weeks, 16 weeks, and 4 weeks after re-visit

    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 elbow flexor and finger flexor at week 4 and 16 after administration compared to baseline, and at 4 weeks after re-administration compared to the time of re-visit.

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

    Time frame: 16 weeks, and 4 weeks after re-visit

    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 at week 16 after administration compared to baseline, and at 4 weeks after re-administration compared to the time of re-visit.

  3. The effective rate of wrist flexor, elbow flexor, and finger flexor

    Time frame: 4 weeks, 16 weeks, and 4 weeks after re-visit

    The effective rate of wrist flexor, elbow flexor, and finger flexor at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit, defining the muscle with MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) score of ≥1 among the wrist flexor, elbow flexor, and finger flexor muscles as responders when the MAS is reduced by 1 score compared to baseline (week 0).

  4. Change in DAS (Disability Assessment Scale) score

    Time frame: 4 weeks, 16 weeks, and 4 weeks after re-visit

    Change in score of goal assessment section in DAS (Disability Assessment Scale: Measures disability associated with upper limb spasticity in patients; score 0 to 3, 3 being the most severe disability) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.

  5. Change in QOL (SF-36v2; Quality of Life) score

    Time frame: 4 weeks, 16 weeks, and 4 weeks after re-visit

    Change in score of Short Form 36 ver.2 (SF-36v2; Quality of Life, QOL: a questionnaire with 36 questions regarding general health change affecting patient's quality of life; score from 1 up to 5, from minimum to high impact on quality of life) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.

  6. Subject's or caregiver's global assessment

    Time frame: 4 weeks, 16 weeks, and 4 weeks after re-visit

    Subject's or caregiver's global assessment (rating from -3 to +3 on the overall treatment effect, with +3 being very satisfied with treatment) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.

  7. Number of participants with Adverse Events (AEs) to assess safety of investigational product.

    Time frame: Through study completion, an average of 1 year

    Safety of IP assessed by the number of partiicipants with adverse events determined by MedDra ver 16.0 from enrollment to the end of study.

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Apr 9, 2019
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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