Spasticity, Muscle
Conditions
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.
Interventions
DRUGMeditoxin
Meditoxin® (Botulinum toxin type A) was injected up to 360 U.
Sponsors
Medy-Tox
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor | 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. |
| The effective rate of wrist flexor, elbow flexor, and finger flexor | 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). |
| Change in DAS (Disability Assessment Scale) score | 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. |
| 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: 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. |
| Subject's or caregiver's global assessment | 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. |
| Number of participants with Adverse Events (AEs) to assess safety of investigational product. | 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. |
| Change in QOL (SF-36v2; Quality of Life) score | 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. |
Outcome results
None listed