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Trial record 27 of 737 for:    Botulinum Toxins, Type A

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

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ClinicalTrials.gov Identifier: NCT03908580
Recruitment Status : Completed
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

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".

Condition or disease Intervention/treatment Phase
Spasticity, Muscle Drug: Meditoxin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 6, 2013
Actual Primary Completion Date : October 31, 2014
Actual Study Completion Date : March 31, 2015

Arm Intervention/treatment
Experimental: Meditoxin®
Botulinum toxin type A was intramuscularly injected up to 360U and up to 4 sites, depending on the muscle size.
Drug: Meditoxin
Meditoxin® (Botulinum toxin type A) was injected up to 360 U.
Other Name: Neuronox®




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT03908580     History of Changes
Other Study ID Numbers: MT_PRT_ST02
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Botulinum Toxins, Type A
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents