Spasticity
Conditions
Keywords
spasticity, upperlimb, Botulinum toxin
Brief summary
This study is a randomized, double blind, multi-center, active drug controlled, phase III clinical trial to compare the efficacy and safety of MEDITOXIN® versus BOTOX® in treatment of post stroke upper limb(wrist, finger, thumb) spasticity Approximately 196 subjects(1:1 group ratio)will be enrolled. Subjects will receive a single treatment of intramuscular Investigational product up to 360U. The subjects will be observed every 4 weeks until 12 weeks post injection. Outcome measures include Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS), Global Assessment Scale(patient or caregiver/investigator) and Carer burden scale. The primary efficacy endpoint is the change from baseline at week 4 for wrist flexor muscle tone as measured on the Modified Ashworth Scale. Safety parameters will also be measured including adverse events, vital signs and clinical laboratory tests (haematology, serum chemistry and urinanalysis).
Detailed description
Each completed subject will attend 4\ 5 clinic visits. The maximum study duration is 15 weeks. Only one upper limb (eligible inclusion/exclusion criteria) will be injected and evaluated in the study. Maximun injection dose is 360U.
Interventions
DRUGBotulinum toxin type A
Botulinum toxin type A
DRUGBotulinum Toxin type A
Botulinum Toxin type A
Sponsors
Medy-Tox
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients ≥ 20 years 2. ≥ 6 weeks since the last stroke 3. ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 points at least one of elbow flexor and finger flexor as measured on MAS(0 to 4) 4. Targeted one functional disability item (i.e., hygiene, dressing, pain, or cosmesis) with a rating of 2 or greater on DAS (0 to 3) 5. Informed consent has been obtained.
Exclusion criteria
1. Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis 2. History(within 6 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection or surgery in the target limb 3. History(within 6 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb 4. Fixed joint/muscle contracture 5. Severe atrophy 6. Concurrent treatment with an intrathecal baclofen 7. History(within 3 months of screening visit) Planned(during study period) treatment with Botulinum Toxin 8. Known allergy or sensitivity to study medication or its components 9. Concurrent or planed Muscle relaxants and/or benzodiazepine medication * If patient has taken these medication stable from one month before screening and no treatment changes are not planned during the study, participation is allowed. 10. Current Physical, occupational, Splinting therapy * If these therapy regimens will be permitted if they has been stable in the one month before screening;no treatment and no changes are planned during the study. 11. Patient who are participating in other clinical trials at the screening 12. Females who are pregnant, breatfeeding,or planning a pregnancy during the study period, or female of childbearing potential, not using a reliable means of centraception. 13. Patients who are not eligible for this study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAS(Modified Ashworth Scale) of Wrist Flexor | Baseline and 4 weeks | Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale). The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MAS(Modified Ashworth Scale) of Wrist Flexor | Baseline, week 8 and week 12 | Change from baseline at week 8 and 12 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale). The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| MAS(Modified Ashworth Score) of Elbow Flexor | Baseline, week 4, week 8 and week 12 | Change from baseline at week 4, week 8 and 12 for elbow flexor muscle tone as measured on the MAS(Modified Ashworth Scale). The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| MAS(Modified Ashworth Score) of Finger Flexor | Baseline, week 4, week 8 and week 12 | Change from baseline at week 4, week 8 and 12 for finger flexor muscle tone as measured on the MAS(Modified Ashworth Scale). The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| MAS(Modified Ashworth Score) of Thumb Flexor | Baseline, week 4, week 8 and week 12 | Change from baseline at week 4, 8, 12 for thumb flexor muscle tone as measured on MAS. The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor | week 4, week 8, week 12 | Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of wrist flexor. \* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site. |
| Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor | week 4, week 8, week 12 | Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of elbow flexor. \* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site |
| Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor | week 4, week 8, week 12 | Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of finger flexor. \* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site. |
| Global Assessment by Investigator | week 12 | Global assessment evaluated by investigator at week 12 after injection |
| Global Assessment by Patient or Caregiver | week 12 | Global assessment evaluated by patient or caregiver at week 12 after injection |
| DAS(Disability Assessment Scale) of Hygiene | Baseline, week 4, week 8 and week 12 | Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Hygiene. The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| DAS(Disability Assessment Scale) of Dressing | Baseline, week 4, week 8 and week 12 | Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Dressing. The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| DAS(Disability Assessment Scale) of Limb Position | Baseline, week 4, week 8 and week 12 | Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Limb Position. The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| DAS(Disability Assessment Scale) of Pain | Baseline, week 4, week 8 and week 12 | Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Pain. The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Carer Burden Scale of Cleaning the Palm | Baseline, week 4, week 8 and week 12 | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Carer Burden Scale of Cutting the Finger-nails | Baseline, week 4, week 8 and week 12 | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Carer Burden Scale of Putting Shirts on | Baseline, week 4, week 8 and week 12 | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Carer Burden Scale of Cleaning the Armpit | Baseline, week 4, week 8 and week 12 | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor | week 4, week 8, week 12 | Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of thumb flexor. \* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site. |
Countries
South Korea
Participant flow
Recruitment details
In this study, total 208 patients were screened and total 196 subjects (98 subjects per group) were randomized, except 12 screening-failures, at 5 study sites.
Pre-assignment details
Total 9 subjects were prematurely discontinued from the study due to unmet inclusion/exclusion criteria found after randomization, AEs/SAEs, consent withdrawal and follow-up lost: 7 subjects in study group (7.14%) and 2 subjects in control group (2.04%). Thus total 187 subjects (91 in study group; 96 in control group) completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Meditoxin® Botulinum toxin type A | 94 |
| Botox® Botulinum Toxin type A | 98 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 3 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Meditoxin® | Total | Botox® |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 27 Participants | 56 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants | 136 Participants | 69 Participants |
| Age, Continuous | 57.54 years STANDARD_DEVIATION 11.03 | 57.26 years STANDARD_DEVIATION 12.05 | 56.99 years STANDARD_DEVIATION 13.01 |
| Region of Enrollment Korea, Republic of | 94 participants | 192 participants | 98 participants |
| Sex: Female, Male Female | 29 Participants | 60 Participants | 31 Participants |
| Sex: Female, Male Male | 65 Participants | 132 Participants | 67 Participants |
| Weight | 65.51 kg STANDARD_DEVIATION 10.27 | 64.18 kg STANDARD_DEVIATION 10.02 | 62.94 kg STANDARD_DEVIATION 9.67 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 35 / 98 | 35 / 98 |
| serious Total, serious adverse events | 5 / 98 | 8 / 98 |
Outcome results
Primary
MAS(Modified Ashworth Scale) of Wrist Flexor
Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale). The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Baseline and 4 weeks
Population: The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 subjects for Botox.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Meditoxin® | MAS(Modified Ashworth Scale) of Wrist Flexor | Baseline | 2.41 Scores on a MAS Scale | Standard Deviation 0.61 |
| Meditoxin® | MAS(Modified Ashworth Scale) of Wrist Flexor | Week 4 | 1.02 Scores on a MAS Scale | Standard Deviation 0.81 |
| Meditoxin® | MAS(Modified Ashworth Scale) of Wrist Flexor | Change(Week4-Baseline) | -1.39 Scores on a MAS Scale | Standard Deviation 0.79 |
| Botox® | MAS(Modified Ashworth Scale) of Wrist Flexor | Baseline | 2.52 Scores on a MAS Scale | Standard Deviation 0.66 |
| Botox® | MAS(Modified Ashworth Scale) of Wrist Flexor | Week 4 | 0.96 Scores on a MAS Scale | Standard Deviation 0.64 |
| Botox® | MAS(Modified Ashworth Scale) of Wrist Flexor | Change(Week4-Baseline) | -1.56 Scores on a MAS Scale | Standard Deviation 0.81 |
Comparison: The difference between the two groups was provided with 95% CI. If the upper limit of CI is no greater than 0.45 (non-inferiority margin), the study group was determined not inferior to the control group. Additionally, difference between groups in change from baseline to week 4 in wrist flexor MAS score was compared using two sample t-test.p-value: 0.134795% CI: [-0.05, 0.4]t-test, 2 sided
Secondary
Carer Burden Scale of Cleaning the Armpit
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, week 4, week 8 and week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Meditoxin® | Carer Burden Scale of Cleaning the Armpit | Week 8 | 1.50 Scores on a Carer Burden Scale | Standard Deviation 1.16 |
| Meditoxin® | Carer Burden Scale of Cleaning the Armpit | Change(Week 4 - Baseline) | -0.39 Scores on a Carer Burden Scale | Standard Deviation 1.12 |
| Meditoxin® | Carer Burden Scale of Cleaning the Armpit | Week 4 | 1.56 Scores on a Carer Burden Scale | Standard Deviation 1.15 |
| Meditoxin® | Carer Burden Scale of Cleaning the Armpit | Change(Week 8 - Baseline) | -0.48 Scores on a Carer Burden Scale | Standard Deviation 1.12 |
| Meditoxin® | Carer Burden Scale of Cleaning the Armpit | Week 12 | 1.42 Scores on a Carer Burden Scale | Standard Deviation 1.15 |
| Meditoxin® | Carer Burden Scale of Cleaning the Armpit | Change(Week 12 - Baseline) | -0.55 Scores on a Carer Burden Scale | Standard Deviation 1.19 |
| Meditoxin® | Carer Burden Scale of Cleaning the Armpit | Baseline | 1.98 Scores on a Carer Burden Scale | Standard Deviation 1.21 |
| Botox® | Carer Burden Scale of Cleaning the Armpit | Change(Week 12 - Baseline) | -0.28 Scores on a Carer Burden Scale | Standard Deviation 1.43 |
| Botox® | Carer Burden Scale of Cleaning the Armpit | Baseline | 1.97 Scores on a Carer Burden Scale | Standard Deviation 1.27 |
| Botox® | Carer Burden Scale of Cleaning the Armpit | Week 4 | 1.71 Scores on a Carer Burden Scale | Standard Deviation 1.26 |
| Botox® | Carer Burden Scale of Cleaning the Armpit | Week 8 | 1.59 Scores on a Carer Burden Scale | Standard Deviation 1.29 |
| Botox® | Carer Burden Scale of Cleaning the Armpit | Week 12 | 1.69 Scores on a Carer Burden Scale | Standard Deviation 1.33 |
| Botox® | Carer Burden Scale of Cleaning the Armpit | Change(Week 4 - Baseline) | -0.26 Scores on a Carer Burden Scale | Standard Deviation 1.2 |
| Botox® | Carer Burden Scale of Cleaning the Armpit | Change(Week 8 - Baseline) | -0.38 Scores on a Carer Burden Scale | Standard Deviation 1.26 |
Comparison: Difference between groups in change from baseline to week 4 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.p-value: 0.7014Wilcoxon (Mann-Whitney)
Comparison: Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.p-value: 0.8884Wilcoxon (Mann-Whitney)
Comparison: Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.p-value: 0.284Wilcoxon (Mann-Whitney)
Secondary
Carer Burden Scale of Cleaning the Palm
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, week 4, week 8 and week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Meditoxin® | Carer Burden Scale of Cleaning the Palm | Week 8 | 1.24 Score on a Carer Burden Scale | Standard Deviation 0.96 |
| Meditoxin® | Carer Burden Scale of Cleaning the Palm | Change(Week 4 - Baseline) | -0.40 Score on a Carer Burden Scale | Standard Deviation 1.29 |
| Meditoxin® | Carer Burden Scale of Cleaning the Palm | Week 4 | 1.26 Score on a Carer Burden Scale | Standard Deviation 1.02 |
| Meditoxin® | Carer Burden Scale of Cleaning the Palm | Change(Week 8 - Baseline) | -0.46 Score on a Carer Burden Scale | Standard Deviation 1.24 |
| Meditoxin® | Carer Burden Scale of Cleaning the Palm | Week 12 | 1.18 Score on a Carer Burden Scale | Standard Deviation 1.05 |
| Meditoxin® | Carer Burden Scale of Cleaning the Palm | Change(Week 12 - Baseline) | -0.51 Score on a Carer Burden Scale | Standard Deviation 1.34 |
| Meditoxin® | Carer Burden Scale of Cleaning the Palm | Baseline | 1.70 Score on a Carer Burden Scale | Standard Deviation 1.16 |
| Botox® | Carer Burden Scale of Cleaning the Palm | Change(Week 12 - Baseline) | -0.23 Score on a Carer Burden Scale | Standard Deviation 1.17 |
| Botox® | Carer Burden Scale of Cleaning the Palm | Baseline | 1.67 Score on a Carer Burden Scale | Standard Deviation 1.17 |
| Botox® | Carer Burden Scale of Cleaning the Palm | Week 4 | 1.34 Score on a Carer Burden Scale | Standard Deviation 1 |
| Botox® | Carer Burden Scale of Cleaning the Palm | Week 8 | 1.40 Score on a Carer Burden Scale | Standard Deviation 1.09 |
| Botox® | Carer Burden Scale of Cleaning the Palm | Week 12 | 1.44 Score on a Carer Burden Scale | Standard Deviation 1.09 |
| Botox® | Carer Burden Scale of Cleaning the Palm | Change(Week 4 - Baseline) | -0.34 Score on a Carer Burden Scale | Standard Deviation 1.1 |
| Botox® | Carer Burden Scale of Cleaning the Palm | Change(Week 8 - Baseline) | -0.28 Score on a Carer Burden Scale | Standard Deviation 1.09 |
Comparison: Difference between groups in change from baseline to week 4 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.p-value: 0.8088Wilcoxon (Mann-Whitney)
Comparison: Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.p-value: 0.3702Wilcoxon (Mann-Whitney)
Comparison: Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.p-value: 0.1497Wilcoxon (Mann-Whitney)
Secondary
Carer Burden Scale of Cutting the Finger-nails
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, week 4, week 8 and week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Meditoxin® | Carer Burden Scale of Cutting the Finger-nails | Week 8 | 1.57 Scores on a Carer Burden Scale | Standard Deviation 1.25 |
| Meditoxin® | Carer Burden Scale of Cutting the Finger-nails | Change(Week 4 - Baseline) | -0.47 Scores on a Carer Burden Scale | Standard Deviation 1.26 |
| Meditoxin® | Carer Burden Scale of Cutting the Finger-nails | Week 4 | 1.58 Scores on a Carer Burden Scale | Standard Deviation 1.3 |
| Meditoxin® | Carer Burden Scale of Cutting the Finger-nails | Change(Week 8 - Baseline) | -0.51 Scores on a Carer Burden Scale | Standard Deviation 1.29 |
| Meditoxin® | Carer Burden Scale of Cutting the Finger-nails | Week 12 | 1.59 Scores on a Carer Burden Scale | Standard Deviation 1.32 |
| Meditoxin® | Carer Burden Scale of Cutting the Finger-nails | Change(Week 12 - Baseline) | -0.49 Scores on a Carer Burden Scale | Standard Deviation 1.35 |
| Meditoxin® | Carer Burden Scale of Cutting the Finger-nails | Baseline | 2.08 Scores on a Carer Burden Scale | Standard Deviation 1.34 |
| Botox® | Carer Burden Scale of Cutting the Finger-nails | Change(Week 12 - Baseline) | -0.42 Scores on a Carer Burden Scale | Standard Deviation 1.19 |
| Botox® | Carer Burden Scale of Cutting the Finger-nails | Baseline | 2.22 Scores on a Carer Burden Scale | Standard Deviation 1.27 |
| Botox® | Carer Burden Scale of Cutting the Finger-nails | Week 4 | 1.89 Scores on a Carer Burden Scale | Standard Deviation 1.32 |
| Botox® | Carer Burden Scale of Cutting the Finger-nails | Week 8 | 1.84 Scores on a Carer Burden Scale | Standard Deviation 1.37 |
| Botox® | Carer Burden Scale of Cutting the Finger-nails | Week 12 | 1.81 Scores on a Carer Burden Scale | Standard Deviation 1.35 |
| Botox® | Carer Burden Scale of Cutting the Finger-nails | Change(Week 4 - Baseline) | -0.34 Scores on a Carer Burden Scale | Standard Deviation 1.17 |
| Botox® | Carer Burden Scale of Cutting the Finger-nails | Change(Week 8 - Baseline) | -0.39 Scores on a Carer Burden Scale | Standard Deviation 1.25 |
Comparison: Difference between groups in change from baseline to week 12 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.p-value: 0.7715Wilcoxon (Mann-Whitney)
Comparison: Difference between groups in change from baseline to week 4 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.p-value: 0.9634Wilcoxon (Mann-Whitney)
Comparison: Difference between groups in change from baseline to week 8 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.p-value: 0.7302Wilcoxon (Mann-Whitney)
Secondary
Carer Burden Scale of Putting Shirts on
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, week 4, week 8 and week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Meditoxin® | Carer Burden Scale of Putting Shirts on | Week 8 | 1.34 Scores on a Carer Burden Scale | Standard Deviation 0.96 |
| Meditoxin® | Carer Burden Scale of Putting Shirts on | Change(Week 4 - Baseline) | -0.32 Scores on a Carer Burden Scale | Standard Deviation 1.12 |
| Meditoxin® | Carer Burden Scale of Putting Shirts on | Week 4 | 1.46 Scores on a Carer Burden Scale | Standard Deviation 0.97 |
| Meditoxin® | Carer Burden Scale of Putting Shirts on | Change(Week 8 - Baseline) | -0.46 Scores on a Carer Burden Scale | Standard Deviation 1.11 |
| Meditoxin® | Carer Burden Scale of Putting Shirts on | Week 12 | 1.32 Scores on a Carer Burden Scale | Standard Deviation 1.05 |
| Meditoxin® | Carer Burden Scale of Putting Shirts on | Change(Week 12 - Baseline) | -0.48 Scores on a Carer Burden Scale | Standard Deviation 1.13 |
| Meditoxin® | Carer Burden Scale of Putting Shirts on | Baseline | 1.79 Scores on a Carer Burden Scale | Standard Deviation 1 |
| Botox® | Carer Burden Scale of Putting Shirts on | Change(Week 12 - Baseline) | -0.35 Scores on a Carer Burden Scale | Standard Deviation 1.15 |
| Botox® | Carer Burden Scale of Putting Shirts on | Baseline | 1.64 Scores on a Carer Burden Scale | Standard Deviation 1.11 |
| Botox® | Carer Burden Scale of Putting Shirts on | Week 4 | 1.42 Scores on a Carer Burden Scale | Standard Deviation 1.1 |
| Botox® | Carer Burden Scale of Putting Shirts on | Week 8 | 1.28 Scores on a Carer Burden Scale | Standard Deviation 0.97 |
| Botox® | Carer Burden Scale of Putting Shirts on | Week 12 | 1.30 Scores on a Carer Burden Scale | Standard Deviation 1.07 |
| Botox® | Carer Burden Scale of Putting Shirts on | Change(Week 4 - Baseline) | -0.22 Scores on a Carer Burden Scale | Standard Deviation 0.98 |
| Botox® | Carer Burden Scale of Putting Shirts on | Change(Week 8 - Baseline) | -0.37 Scores on a Carer Burden Scale | Standard Deviation 1.17 |
Comparison: Difference between groups in change from baseline to week 4 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.p-value: 0.9362Wilcoxon (Mann-Whitney)
Comparison: Difference between groups in change from baseline to week 8 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.p-value: 0.7998Wilcoxon (Mann-Whitney)
Comparison: Difference between groups in change from baseline to week 12 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.p-value: 0.5436Wilcoxon (Mann-Whitney)
Secondary
DAS(Disability Assessment Scale) of Dressing
Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Dressing. The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, week 4, week 8 and week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 11 subjects receiving Meditoxin and 15 Botox.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Meditoxin® | DAS(Disability Assessment Scale) of Dressing | Week 8 | 1.36 Scores on a DAS Scale | Standard Deviation 0.5 |
| Meditoxin® | DAS(Disability Assessment Scale) of Dressing | Change(Week 4 - Baseline) | -0.70 Scores on a DAS Scale | Standard Deviation 0.67 |
| Meditoxin® | DAS(Disability Assessment Scale) of Dressing | Week 4 | 1.30 Scores on a DAS Scale | Standard Deviation 0.67 |
| Meditoxin® | DAS(Disability Assessment Scale) of Dressing | Change(Week 8 - Baseline) | -0.73 Scores on a DAS Scale | Standard Deviation 0.47 |
| Meditoxin® | DAS(Disability Assessment Scale) of Dressing | Week 12 | 1.27 Scores on a DAS Scale | Standard Deviation 0.65 |
| Meditoxin® | DAS(Disability Assessment Scale) of Dressing | Change(Week 12 - Baseline) | -0.82 Scores on a DAS Scale | Standard Deviation 0.6 |
| Meditoxin® | DAS(Disability Assessment Scale) of Dressing | Baseline | 2.09 Scores on a DAS Scale | Standard Deviation 0.3 |
| Botox® | DAS(Disability Assessment Scale) of Dressing | Change(Week 12 - Baseline) | -1.14 Scores on a DAS Scale | Standard Deviation 0.66 |
| Botox® | DAS(Disability Assessment Scale) of Dressing | Baseline | 2.13 Scores on a DAS Scale | Standard Deviation 0.35 |
| Botox® | DAS(Disability Assessment Scale) of Dressing | Week 4 | 1.07 Scores on a DAS Scale | Standard Deviation 0.47 |
| Botox® | DAS(Disability Assessment Scale) of Dressing | Week 8 | 1.00 Scores on a DAS Scale | Standard Deviation 0.55 |
| Botox® | DAS(Disability Assessment Scale) of Dressing | Week 12 | 1.00 Scores on a DAS Scale | Standard Deviation 0.55 |
| Botox® | DAS(Disability Assessment Scale) of Dressing | Change(Week 4 - Baseline) | -1.07 Scores on a DAS Scale | Standard Deviation 0.47 |
| Botox® | DAS(Disability Assessment Scale) of Dressing | Change(Week 8 - Baseline) | -1.14 Scores on a DAS Scale | Standard Deviation 0.66 |
Comparison: Difference between groups in change from baseline to week 4 in DAS score of dressing was compared using wilcoxon rank sum test.p-value: 0.122Wilcoxon (Mann-Whitney)
Comparison: Difference between groups in change from baseline to week 8 in DAS score of dressing was compared using wilcoxon rank sum test.p-value: 0.1016Wilcoxon (Mann-Whitney)
Comparison: Difference between groups in change from baseline to week 12 in DAS score of dressing was compared using wilcoxon rank sum test.p-value: 0.2235Wilcoxon (Mann-Whitney)
Secondary
DAS(Disability Assessment Scale) of Hygiene
Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Hygiene. The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, week 4, week 8 and week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 39 subjects receiving Meditoxin and 34 Botox.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Meditoxin® | DAS(Disability Assessment Scale) of Hygiene | Week 8 | 1.85 Scores on a DAS Scale | Standard Deviation 0.99 |
| Meditoxin® | DAS(Disability Assessment Scale) of Hygiene | Change(Week 4 - Baseline) | -0.72 Scores on a DAS Scale | Standard Deviation 0.79 |
| Meditoxin® | DAS(Disability Assessment Scale) of Hygiene | Week 4 | 1.90 Scores on a DAS Scale | Standard Deviation 1.02 |
| Meditoxin® | DAS(Disability Assessment Scale) of Hygiene | Change(Week 8 - Baseline) | -0.77 Scores on a DAS Scale | Standard Deviation 0.67 |
| Meditoxin® | DAS(Disability Assessment Scale) of Hygiene | Week 12 | 1.87 Scores on a DAS Scale | Standard Deviation 0.98 |
| Meditoxin® | DAS(Disability Assessment Scale) of Hygiene | Change(Week 12 - Baseline) | -0.74 Scores on a DAS Scale | Standard Deviation 0.75 |
| Meditoxin® | DAS(Disability Assessment Scale) of Hygiene | Baseline | 2.62 Scores on a DAS Scale | Standard Deviation 0.49 |
| Botox® | DAS(Disability Assessment Scale) of Hygiene | Change(Week 12 - Baseline) | -0.62 Scores on a DAS Scale | Standard Deviation 0.6 |
| Botox® | DAS(Disability Assessment Scale) of Hygiene | Baseline | 2.74 Scores on a DAS Scale | Standard Deviation 0.45 |
| Botox® | DAS(Disability Assessment Scale) of Hygiene | Week 4 | 2.09 Scores on a DAS Scale | Standard Deviation 0.87 |
| Botox® | DAS(Disability Assessment Scale) of Hygiene | Week 8 | 2.12 Scores on a DAS Scale | Standard Deviation 0.88 |
| Botox® | DAS(Disability Assessment Scale) of Hygiene | Week 12 | 2.12 Scores on a DAS Scale | Standard Deviation 0.84 |
| Botox® | DAS(Disability Assessment Scale) of Hygiene | Change(Week 4 - Baseline) | -0.65 Scores on a DAS Scale | Standard Deviation 0.65 |
| Botox® | DAS(Disability Assessment Scale) of Hygiene | Change(Week 8 - Baseline) | -0.62 Scores on a DAS Scale | Standard Deviation 0.65 |
Comparison: Difference between groups in change from baseline to week 4 in DAS score of hygiene was compared using wilcoxon rank sum test.p-value: 0.604Wilcoxon (Mann-Whitney)
Comparison: Difference between groups in change from baseline to week 8 in DAS score of hygiene was compared using wilcoxon rank sum test.p-value: 0.3233Wilcoxon (Mann-Whitney)
Comparison: Difference between groups in change from baseline to week 12 in DAS score of hygiene was compared using wilcoxon rank sum test.p-value: 0.4469Wilcoxon (Mann-Whitney)
Secondary
DAS(Disability Assessment Scale) of Limb Position
Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Limb Position. The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, week 4, week 8 and week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 40 subjects receiving Meditoxin and 47 Botox.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Meditoxin® | DAS(Disability Assessment Scale) of Limb Position | Baseline | 2.50 Scores on a DAS Scale | Standard Deviation 0.51 |
| Meditoxin® | DAS(Disability Assessment Scale) of Limb Position | Change(Week 4 - Baseline) | -1.23 Scores on a DAS Scale | Standard Deviation 0.62 |
| Meditoxin® | DAS(Disability Assessment Scale) of Limb Position | Week 4 | 1.28 Scores on a DAS Scale | Standard Deviation 0.55 |
| Meditoxin® | DAS(Disability Assessment Scale) of Limb Position | Change(Week 8 - Baseline) | -1.23 Scores on a DAS Scale | Standard Deviation 0.66 |
| Meditoxin® | DAS(Disability Assessment Scale) of Limb Position | Week 12 | 1.29 Scores on a DAS Scale | Standard Deviation 0.56 |
| Meditoxin® | DAS(Disability Assessment Scale) of Limb Position | Change(Week 12 - Baseline) | -1.20 Scores on a DAS Scale | Standard Deviation 0.69 |
| Meditoxin® | DAS(Disability Assessment Scale) of Limb Position | Week 8 | 1.27 Scores on a DAS Scale | Standard Deviation 0.55 |
| Botox® | DAS(Disability Assessment Scale) of Limb Position | Change(Week 12 - Baseline) | -1.21 Scores on a DAS Scale | Standard Deviation 0.55 |
| Botox® | DAS(Disability Assessment Scale) of Limb Position | Baseline | 2.45 Scores on a DAS Scale | Standard Deviation 0.5 |
| Botox® | DAS(Disability Assessment Scale) of Limb Position | Week 4 | 1.29 Scores on a DAS Scale | Standard Deviation 0.54 |
| Botox® | DAS(Disability Assessment Scale) of Limb Position | Week 8 | 1.25 Scores on a DAS Scale | Standard Deviation 0.53 |
| Botox® | DAS(Disability Assessment Scale) of Limb Position | Week 12 | 1.23 Scores on a DAS Scale | Standard Deviation 0.47 |
| Botox® | DAS(Disability Assessment Scale) of Limb Position | Change(Week 4 - Baseline) | -1.15 Scores on a DAS Scale | Standard Deviation 0.55 |
| Botox® | DAS(Disability Assessment Scale) of Limb Position | Change(Week 8 - Baseline) | -1.19 Scores on a DAS Scale | Standard Deviation 0.54 |
Comparison: Difference between groups in change from baseline to week 4 in DAS score of limb position was compared using wilcoxon rank sum test.p-value: 0.503Wilcoxon (Mann-Whitney)
Comparison: Difference between groups in change from baseline to week 8 in DAS score of limb position was compared using wilcoxon rank sum test.p-value: 0.6934Wilcoxon (Mann-Whitney)
Comparison: Difference between groups in change from baseline to week 12 in DAS score of limb position was compared using wilcoxon rank sum test.p-value: 0.9574Wilcoxon (Mann-Whitney)
Secondary
DAS(Disability Assessment Scale) of Pain
Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Pain. The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, week 4, week 8 and week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 4 subjects receiving Meditoxin and 2 Botox.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Meditoxin® | DAS(Disability Assessment Scale) of Pain | Week 8 | 0.75 Scores on a DAS Scale | Standard Deviation 0.5 |
| Meditoxin® | DAS(Disability Assessment Scale) of Pain | Change(Week 4 - Baseline) | -0.75 Scores on a DAS Scale | Standard Deviation 0.5 |
| Meditoxin® | DAS(Disability Assessment Scale) of Pain | Week 4 | 1.25 Scores on a DAS Scale | Standard Deviation 0.5 |
| Meditoxin® | DAS(Disability Assessment Scale) of Pain | Change(Week 8 - Baseline) | -1.25 Scores on a DAS Scale | Standard Deviation 0.5 |
| Meditoxin® | DAS(Disability Assessment Scale) of Pain | Week 12 | 0.50 Scores on a DAS Scale | Standard Deviation 0.58 |
| Meditoxin® | DAS(Disability Assessment Scale) of Pain | Change(Week 12 - Baseline) | -1.50 Scores on a DAS Scale | Standard Deviation 0.58 |
| Meditoxin® | DAS(Disability Assessment Scale) of Pain | Baseline | 2.00 Scores on a DAS Scale | Standard Deviation 0 |
| Botox® | DAS(Disability Assessment Scale) of Pain | Change(Week 12 - Baseline) | -2.00 Scores on a DAS Scale | Standard Deviation 0 |
| Botox® | DAS(Disability Assessment Scale) of Pain | Baseline | 2.00 Scores on a DAS Scale | Standard Deviation 0 |
| Botox® | DAS(Disability Assessment Scale) of Pain | Week 4 | 1.00 Scores on a DAS Scale | Standard Deviation 0 |
| Botox® | DAS(Disability Assessment Scale) of Pain | Week 8 | 1.00 Scores on a DAS Scale | Standard Deviation 0 |
| Botox® | DAS(Disability Assessment Scale) of Pain | Week 12 | 0.00 Scores on a DAS Scale | Standard Deviation 0 |
| Botox® | DAS(Disability Assessment Scale) of Pain | Change(Week 4 - Baseline) | -1.00 Scores on a DAS Scale | Standard Deviation 0 |
| Botox® | DAS(Disability Assessment Scale) of Pain | Change(Week 8 - Baseline) | -1.00 Scores on a DAS Scale | Standard Deviation 0 |
Comparison: Difference between groups in change from baseline to week 4 in DAS score of pain was compared using wilcoxon rank sum test.p-value: 0.7237Wilcoxon (Mann-Whitney)
Comparison: Difference between groups in change from baseline to week 8 in DAS score of pain was compared using wilcoxon rank sum test.p-value: 0.7237Wilcoxon (Mann-Whitney)
Comparison: Difference between groups in change from baseline to week 12 in DAS score of pain was compared using wilcoxon rank sum test.p-value: 0.4017Wilcoxon (Mann-Whitney)
Secondary
Global Assessment by Investigator
Global assessment evaluated by investigator at week 12 after injection
Time frame: week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Meditoxin® | Global Assessment by Investigator | Very good | 19 participants |
| Meditoxin® | Global Assessment by Investigator | Moderate | 10 participants |
| Meditoxin® | Global Assessment by Investigator | Good | 63 participants |
| Meditoxin® | Global Assessment by Investigator | Insufficient | 1 participants |
| Botox® | Global Assessment by Investigator | Insufficient | 4 participants |
| Botox® | Global Assessment by Investigator | Very good | 19 participants |
| Botox® | Global Assessment by Investigator | Good | 56 participants |
| Botox® | Global Assessment by Investigator | Moderate | 18 participants |
Comparison: Difference between groups in frequency distribution of responders on the Global Assessment at week 12 was compared using Fisher's exact test.p-value: 0.2346Fisher Exact
Secondary
Global Assessment by Patient or Caregiver
Global assessment evaluated by patient or caregiver at week 12 after injection
Time frame: week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Meditoxin® | Global Assessment by Patient or Caregiver | Very good | 11 participants |
| Meditoxin® | Global Assessment by Patient or Caregiver | Good | 39 participants |
| Meditoxin® | Global Assessment by Patient or Caregiver | Moderate | 36 participants |
| Meditoxin® | Global Assessment by Patient or Caregiver | Insufficient | 7 participants |
| Botox® | Global Assessment by Patient or Caregiver | Insufficient | 8 participants |
| Botox® | Global Assessment by Patient or Caregiver | Very good | 10 participants |
| Botox® | Global Assessment by Patient or Caregiver | Moderate | 35 participants |
| Botox® | Global Assessment by Patient or Caregiver | Good | 44 participants |
Comparison: Difference between groups in frequency distribution of responders on the Global Assessment at week 12 was compared using Fisher's exact test.p-value: 0.9513Fisher Exact
Secondary
Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor
Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of elbow flexor. \* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site
Time frame: week 4, week 8, week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 87 subjects receiving Meditoxin and 94 Botox.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Meditoxin® | Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor | Week 4 | 56 Subjects who improved 1-point on MAS |
| Meditoxin® | Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor | Week 8 | 49 Subjects who improved 1-point on MAS |
| Meditoxin® | Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor | Week 12 | 46 Subjects who improved 1-point on MAS |
| Botox® | Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor | Week 4 | 52 Subjects who improved 1-point on MAS |
| Botox® | Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor | Week 8 | 42 Subjects who improved 1-point on MAS |
| Botox® | Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor | Week 12 | 39 Subjects who improved 1-point on MAS |
Comparison: Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in elbow flexor was compared using Pearson's chi-square test.p-value: 0.1802Chi-squared
Comparison: Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in elbow flexor was compared using Pearson's chi-square test.p-value: 0.1176Chi-squared
Comparison: Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in elbow flexor was compared using Pearson's chi-square test.p-value: 0.1252Chi-squared
Secondary
Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor
Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of finger flexor. \* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site.
Time frame: week 4, week 8, week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 82 subjects receiving Meditoxin and 83 Botox.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Meditoxin® | Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor | Week 4 | 58 Subjects who improved 1-point on MAS |
| Meditoxin® | Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor | Week 8 | 51 Subjects who improved 1-point on MAS |
| Meditoxin® | Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor | Week 12 | 47 Subjects who improved 1-point on MAS |
| Botox® | Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor | Week 4 | 64 Subjects who improved 1-point on MAS |
| Botox® | Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor | Week 8 | 60 Subjects who improved 1-point on MAS |
| Botox® | Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor | Week 12 | 54 Subjects who improved 1-point on MAS |
Comparison: Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in finger flexor was compared using Pearson's chi-square test.p-value: 0.3431Chi-squared
Comparison: Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in finger flexor was compared using Pearson's chi-square testp-value: 0.1329Chi-squared
Comparison: Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in finger flexor was compared using Pearson's chi-square testp-value: 0.2611Chi-squared
Secondary
Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor
Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of thumb flexor. \* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site.
Time frame: week 4, week 8, week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 54 subjects receiving Meditoxin and 58 Botox.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Meditoxin® | Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor | Week 4 | 34 Subjects who improved 1-point on MAS |
| Meditoxin® | Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor | Week 8 | 28 Subjects who improved 1-point on MAS |
| Meditoxin® | Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor | Week 12 | 27 Subjects who improved 1-point on MAS |
| Botox® | Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor | Week 4 | 41 Subjects who improved 1-point on MAS |
| Botox® | Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor | Week 8 | 37 Subjects who improved 1-point on MAS |
| Botox® | Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor | Week 12 | 30 Subjects who improved 1-point on MAS |
Comparison: Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in thumb flexor was compared using Pearson's chi-square test.p-value: 0.4623Chi-squared
Comparison: Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in thumb flexor was compared using Pearson's chi-square test.p-value: 0.2007Chi-squared
Comparison: Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in thumb flexor was compared using Pearson's chi-square test.p-value: 0.8553Chi-squared
Secondary
Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor
Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of wrist flexor. \* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site.
Time frame: week 4, week 8, week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Meditoxin® | Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor | Week 4 | 77 Subjects who improved 1-point on MAS |
| Meditoxin® | Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor | Week 8 | 77 Subjects who improved 1-point on MAS |
| Meditoxin® | Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor | Week 12 | 71 Subjects who improved 1-point on MAS |
| Botox® | Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor | Week 4 | 88 Subjects who improved 1-point on MAS |
| Botox® | Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor | Week 8 | 80 Subjects who improved 1-point on MAS |
| Botox® | Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor | Week 12 | 77 Subjects who improved 1-point on MAS |
Comparison: Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in wrist flexor was compared using Pearson's chi-square test.p-value: 0.1585Chi-squared
Comparison: Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in wrist flexor was compared using Pearson's chi-square test.p-value: 0.9596Chi-squared
Comparison: Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in wrist flexor was compared using Pearson's chi-square test.p-value: 0.6164Chi-squared
Secondary
MAS(Modified Ashworth Scale) of Wrist Flexor
Change from baseline at week 8 and 12 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale). The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Baseline, week 8 and week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Meditoxin® | MAS(Modified Ashworth Scale) of Wrist Flexor | Week 8 | 1.07 Scores on a MAS scale | Standard Deviation 0.78 |
| Meditoxin® | MAS(Modified Ashworth Scale) of Wrist Flexor | Change(Week 8 - Baseline) | -1.35 Scores on a MAS scale | Standard Deviation 0.77 |
| Meditoxin® | MAS(Modified Ashworth Scale) of Wrist Flexor | Week 12 | 1.16 Scores on a MAS scale | Standard Deviation 0.86 |
| Meditoxin® | MAS(Modified Ashworth Scale) of Wrist Flexor | Change(Week12 - Baseline) | -1.25 Scores on a MAS scale | Standard Deviation 0.78 |
| Meditoxin® | MAS(Modified Ashworth Scale) of Wrist Flexor | Baseline | 2.41 Scores on a MAS scale | Standard Deviation 0.61 |
| Botox® | MAS(Modified Ashworth Scale) of Wrist Flexor | Change(Week12 - Baseline) | -1.36 Scores on a MAS scale | Standard Deviation 0.84 |
| Botox® | MAS(Modified Ashworth Scale) of Wrist Flexor | Baseline | 2.52 Scores on a MAS scale | Standard Deviation 0.66 |
| Botox® | MAS(Modified Ashworth Scale) of Wrist Flexor | Week 8 | 1.04 Scores on a MAS scale | Standard Deviation 1.16 |
| Botox® | MAS(Modified Ashworth Scale) of Wrist Flexor | Week 12 | 1.16 Scores on a MAS scale | Standard Deviation 0.66 |
| Botox® | MAS(Modified Ashworth Scale) of Wrist Flexor | Change(Week 8 - Baseline) | -1.48 Scores on a MAS scale | Standard Deviation 0.87 |
Comparison: Difference between groups in change from baseline to week 8 in wrist flexor MAS score was compared using two sample t-test.p-value: 0.2591t-test, 2 sided
Comparison: Difference between groups in change from baseline to week 12 in wrist flexor MAS score was compared using two sample t-test.p-value: 0.3395t-test, 2 sided
Secondary
MAS(Modified Ashworth Score) of Elbow Flexor
Change from baseline at week 4, week 8 and 12 for elbow flexor muscle tone as measured on the MAS(Modified Ashworth Scale). The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Baseline, week 4, week 8 and week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 87 subjects receiving Meditoxin and 94 Botox.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Meditoxin® | MAS(Modified Ashworth Score) of Elbow Flexor | Week 8 | 1.36 Scores on a MAS Scale | Standard Deviation 0.54 |
| Meditoxin® | MAS(Modified Ashworth Score) of Elbow Flexor | Change(Week 4 - Baseline) | -1.07 Scores on a MAS Scale | Standard Deviation 0.73 |
| Meditoxin® | MAS(Modified Ashworth Score) of Elbow Flexor | Week 4 | 1.26 Scores on a MAS Scale | Standard Deviation 0.73 |
| Meditoxin® | MAS(Modified Ashworth Score) of Elbow Flexor | Change(Week 8 - Baseline) | -0.97 Scores on a MAS Scale | Standard Deviation 0.74 |
| Meditoxin® | MAS(Modified Ashworth Score) of Elbow Flexor | Week 12 | 1.45 Scores on a MAS Scale | Standard Deviation 0.68 |
| Meditoxin® | MAS(Modified Ashworth Score) of Elbow Flexor | Change(Week 12 - Baseline) | -0.88 Scores on a MAS Scale | Standard Deviation 0.75 |
| Meditoxin® | MAS(Modified Ashworth Score) of Elbow Flexor | Baseline | 2.33 Scores on a MAS Scale | Standard Deviation 0.75 |
| Botox® | MAS(Modified Ashworth Score) of Elbow Flexor | Change(Week 12 - Baseline) | -0.65 Scores on a MAS Scale | Standard Deviation 0.74 |
| Botox® | MAS(Modified Ashworth Score) of Elbow Flexor | Baseline | 2.18 Scores on a MAS Scale | Standard Deviation 0.65 |
| Botox® | MAS(Modified Ashworth Score) of Elbow Flexor | Week 4 | 1.30 Scores on a MAS Scale | Standard Deviation 0.58 |
| Botox® | MAS(Modified Ashworth Score) of Elbow Flexor | Week 8 | 1.41 Scores on a MAS Scale | Standard Deviation 0.58 |
| Botox® | MAS(Modified Ashworth Score) of Elbow Flexor | Week 12 | 1.52 Scores on a MAS Scale | Standard Deviation 0.6 |
| Botox® | MAS(Modified Ashworth Score) of Elbow Flexor | Change(Week 4 - Baseline) | -0.87 Scores on a MAS Scale | Standard Deviation 0.71 |
| Botox® | MAS(Modified Ashworth Score) of Elbow Flexor | Change(Week 8 - Baseline) | -0.77 Scores on a MAS Scale | Standard Deviation 0.72 |
Comparison: Difference between groups in change from baseline to week 4 in elbow flexor MAS score was compared using two sample t-test.p-value: 0.0675t-test, 2 sided
Comparison: Difference between groups in change from baseline to week 8 in elbow flexor MAS score was compared using two sample t-test.p-value: 0.0605t-test, 2 sided
Comparison: Difference between groups in change from baseline to week 12 in elbow flexor MAS score was compared using two sample t-test.p-value: 0.0429t-test, 2 sided
Secondary
MAS(Modified Ashworth Score) of Finger Flexor
Change from baseline at week 4, week 8 and 12 for finger flexor muscle tone as measured on the MAS(Modified Ashworth Scale). The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Baseline, week 4, week 8 and week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 82 subjects receiving Meditoxin and 83 Botox.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Meditoxin® | MAS(Modified Ashworth Score) of Finger Flexor | Week 8 | 1.15 Score on a MAS Scale | Standard Deviation 0.62 |
| Meditoxin® | MAS(Modified Ashworth Score) of Finger Flexor | Change(Week 4 - Baseline) | -1.36 Score on a MAS Scale | Standard Deviation 0.9 |
| Meditoxin® | MAS(Modified Ashworth Score) of Finger Flexor | Week 4 | 1.01 Score on a MAS Scale | Standard Deviation 0.67 |
| Meditoxin® | MAS(Modified Ashworth Score) of Finger Flexor | Change(Week 8 - Baseline) | -1.23 Score on a MAS Scale | Standard Deviation 0.89 |
| Meditoxin® | MAS(Modified Ashworth Score) of Finger Flexor | Week 12 | 1.20 Score on a MAS Scale | Standard Deviation 0.68 |
| Meditoxin® | MAS(Modified Ashworth Score) of Finger Flexor | Change(Week 12 - Baseline) | -1.18 Score on a MAS Scale | Standard Deviation 0.9 |
| Meditoxin® | MAS(Modified Ashworth Score) of Finger Flexor | Baseline | 2.37 Score on a MAS Scale | Standard Deviation 0.8 |
| Botox® | MAS(Modified Ashworth Score) of Finger Flexor | Change(Week 12 - Baseline) | -1.16 Score on a MAS Scale | Standard Deviation 0.91 |
| Botox® | MAS(Modified Ashworth Score) of Finger Flexor | Baseline | 2.48 Score on a MAS Scale | Standard Deviation 0.75 |
| Botox® | MAS(Modified Ashworth Score) of Finger Flexor | Week 4 | 1.05 Score on a MAS Scale | Standard Deviation 0.66 |
| Botox® | MAS(Modified Ashworth Score) of Finger Flexor | Week 8 | 1.17 Score on a MAS Scale | Standard Deviation 0.66 |
| Botox® | MAS(Modified Ashworth Score) of Finger Flexor | Week 12 | 1.30 Score on a MAS Scale | Standard Deviation 0.66 |
| Botox® | MAS(Modified Ashworth Score) of Finger Flexor | Change(Week 4 - Baseline) | -1.42 Score on a MAS Scale | Standard Deviation 0.94 |
| Botox® | MAS(Modified Ashworth Score) of Finger Flexor | Change(Week 8 - Baseline) | -1.30 Score on a MAS Scale | Standard Deviation 0.91 |
Comparison: Difference between groups in change from baseline to week 4 in finger flexor MAS score was compared using two sample t-test.p-value: 0.6954t-test, 2 sided
Comparison: Difference between groups in change from baseline to week 8 in finger flexor MAS score was compared using two sample t-test.p-value: 0.6024t-test, 2 sided
Comparison: Difference between groups in change from baseline to week 12 in finger flexor MAS score was compared using two sample t-test.p-value: 0.9316t-test, 2 sided
Secondary
MAS(Modified Ashworth Score) of Thumb Flexor
Change from baseline at week 4, 8, 12 for thumb flexor muscle tone as measured on MAS. The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Baseline, week 4, week 8 and week 12
Population: The analysis was performed on the Full Analysis Set population which consisted of 54 subjects receiving Meditoxin and 58 Botox.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Meditoxin® | MAS(Modified Ashworth Score) of Thumb Flexor | Week 12 | 1.06 Scores on a MAS Scale | Standard Deviation 0.84 |
| Meditoxin® | MAS(Modified Ashworth Score) of Thumb Flexor | Baseline | 1.94 Scores on a MAS Scale | Standard Deviation 0.73 |
| Meditoxin® | MAS(Modified Ashworth Score) of Thumb Flexor | Change(Week 4 - Baseline) | -1.06 Scores on a MAS Scale | Standard Deviation 0.85 |
| Meditoxin® | MAS(Modified Ashworth Score) of Thumb Flexor | Week 8 | 1.01 Scores on a MAS Scale | Standard Deviation 0.67 |
| Meditoxin® | MAS(Modified Ashworth Score) of Thumb Flexor | Change(Week 8 - Baseline) | -0.94 Scores on a MAS Scale | Standard Deviation 0.85 |
| Meditoxin® | MAS(Modified Ashworth Score) of Thumb Flexor | Change(Week 12 - Baseline) | -0.89 Scores on a MAS Scale | Standard Deviation 0.99 |
| Meditoxin® | MAS(Modified Ashworth Score) of Thumb Flexor | Week 4 | 0.89 Scores on a MAS Scale | Standard Deviation 0.71 |
| Botox® | MAS(Modified Ashworth Score) of Thumb Flexor | Change(Week 12 - Baseline) | -0.98 Scores on a MAS Scale | Standard Deviation 0.86 |
| Botox® | MAS(Modified Ashworth Score) of Thumb Flexor | Baseline | 1.94 Scores on a MAS Scale | Standard Deviation 0.74 |
| Botox® | MAS(Modified Ashworth Score) of Thumb Flexor | Week 4 | 0.69 Scores on a MAS Scale | Standard Deviation 0.66 |
| Botox® | MAS(Modified Ashworth Score) of Thumb Flexor | Week 8 | 0.84 Scores on a MAS Scale | Standard Deviation 0.77 |
| Botox® | MAS(Modified Ashworth Score) of Thumb Flexor | Week 12 | 0.96 Scores on a MAS Scale | Standard Deviation 0.69 |
| Botox® | MAS(Modified Ashworth Score) of Thumb Flexor | Change(Week 4 - Baseline) | -1.25 Scores on a MAS Scale | Standard Deviation 0.83 |
| Botox® | MAS(Modified Ashworth Score) of Thumb Flexor | Change(Week 8 - Baseline) | -1.09 Scores on a MAS Scale | Standard Deviation 0.85 |
Comparison: Difference between groups in change from baseline to week 4 in thumb flexor MAS score was compared using two sample t-test.p-value: 0.2284t-test, 2 sided
Comparison: Difference between groups in change from baseline to week 8 in thumb flexor MAS score was compared using two sample t-test.p-value: 0.3221t-test, 2 sided
Comparison: Difference between groups in change from baseline to week 12 in thumb flexor MAS score was compared using two sample t-test.p-value: 0.593t-test, 2 sided