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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03908580
Other study ID # MT_PRT_ST02
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 6, 2013
Est. completion date March 31, 2015

Study information

Verified date April 2019
Source Medy-Tox
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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".


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date March 31, 2015
Est. primary completion date October 31, 2014
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medy-Tox

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in muscle tone determined by MAS (Modified Ashworth Scale) of elbow flexor and finger 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 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. 4 weeks, 16 weeks, and 4 weeks after re-visit
Secondary 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 at week 16 after administration compared to baseline, and at 4 weeks after re-administration compared to the time of re-visit. 16 weeks, and 4 weeks after re-visit
Secondary The effective rate of wrist flexor, elbow flexor, and finger flexor 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 weeks, 16 weeks, and 4 weeks after re-visit
Secondary Change in DAS (Disability Assessment Scale) score 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. 4 weeks, 16 weeks, and 4 weeks after re-visit
Secondary Change in QOL (SF-36v2; Quality of Life) score 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. 4 weeks, 16 weeks, and 4 weeks after re-visit
Secondary Subject's or caregiver's global assessment 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. 4 weeks, 16 weeks, and 4 weeks after re-visit
Secondary Number of participants with Adverse Events (AEs) to assess safety of investigational product. 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. Through study completion, an average of 1 year
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