Trial Outcomes & Findings for MEDITOXIN® Versus BOTOX® in the Treatment of Post-stroke Spasticity of the Upper Limb Spasticity (NCT NCT01313767)
NCT ID: NCT01313767
Last Updated: 2019-03-29
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
196 participants
Primary outcome timeframe
Baseline and 4 weeks
Results posted on
2019-03-29
Participant Flow
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.
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.
Participant milestones
| Measure |
Meditoxin®
Clostridium Botulinum toxin type A, up to total 360U injected into selected sites, Intra-muscle
|
Botox®
Clostridium Botulinum toxin type A, up to total 360U injected into selected sites, Intra-muscle
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
98
|
|
Overall Study
COMPLETED
|
91
|
96
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
Meditoxin®
Clostridium Botulinum toxin type A, up to total 360U injected into selected sites, Intra-muscle
|
Botox®
Clostridium Botulinum toxin type A, up to total 360U injected into selected sites, Intra-muscle
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Protocol Violation
|
3
|
1
|
Baseline Characteristics
MEDITOXIN® Versus BOTOX® in the Treatment of Post-stroke Spasticity of the Upper Limb Spasticity
Baseline characteristics by cohort
| Measure |
Meditoxin®
n=94 Participants
Botulinum toxin type A
|
Botox®
n=98 Participants
Botulinum Toxin type A
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Age, Continuous
|
57.54 years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
56.99 years
STANDARD_DEVIATION 13.01 • n=7 Participants
|
57.26 years
STANDARD_DEVIATION 12.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
94 participants
n=5 Participants
|
98 participants
n=7 Participants
|
192 participants
n=5 Participants
|
|
Weight
|
65.51 kg
STANDARD_DEVIATION 10.27 • n=5 Participants
|
62.94 kg
STANDARD_DEVIATION 9.67 • n=7 Participants
|
64.18 kg
STANDARD_DEVIATION 10.02 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 subjects for Botox.
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).
Outcome measures
| Measure |
Meditoxin®
n=94 Participants
Botulinum toxin type A
|
Botox®
n=98 Participants
Botulinum Toxin type A
|
|---|---|---|
|
MAS(Modified Ashworth Scale) of Wrist Flexor
Baseline
|
2.41 Scores on a MAS Scale
Standard Deviation 0.61
|
2.52 Scores on a MAS Scale
Standard Deviation 0.66
|
|
MAS(Modified Ashworth Scale) of Wrist Flexor
Week 4
|
1.02 Scores on a MAS Scale
Standard Deviation 0.81
|
0.96 Scores on a MAS Scale
Standard Deviation 0.64
|
|
MAS(Modified Ashworth Scale) of Wrist Flexor
Change(Week4-Baseline)
|
-1.39 Scores on a MAS Scale
Standard Deviation 0.79
|
-1.56 Scores on a MAS Scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Baseline, week 8 and week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox.
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).
Outcome measures
| Measure |
Meditoxin®
n=94 Participants
Botulinum toxin type A
|
Botox®
n=98 Participants
Botulinum Toxin type A
|
|---|---|---|
|
MAS(Modified Ashworth Scale) of Wrist Flexor
Baseline
|
2.41 Scores on a MAS scale
Standard Deviation 0.61
|
2.52 Scores on a MAS scale
Standard Deviation 0.66
|
|
MAS(Modified Ashworth Scale) of Wrist Flexor
Week 8
|
1.07 Scores on a MAS scale
Standard Deviation 0.78
|
1.04 Scores on a MAS scale
Standard Deviation 1.16
|
|
MAS(Modified Ashworth Scale) of Wrist Flexor
Week 12
|
1.16 Scores on a MAS scale
Standard Deviation 0.86
|
1.16 Scores on a MAS scale
Standard Deviation 0.66
|
|
MAS(Modified Ashworth Scale) of Wrist Flexor
Change(Week 8 - Baseline)
|
-1.35 Scores on a MAS scale
Standard Deviation 0.77
|
-1.48 Scores on a MAS scale
Standard Deviation 0.87
|
|
MAS(Modified Ashworth Scale) of Wrist Flexor
Change(Week12 - Baseline)
|
-1.25 Scores on a MAS scale
Standard Deviation 0.78
|
-1.36 Scores on a MAS scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8 and week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 87 subjects receiving Meditoxin and 94 Botox.
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).
Outcome measures
| Measure |
Meditoxin®
n=87 Participants
Botulinum toxin type A
|
Botox®
n=94 Participants
Botulinum Toxin type A
|
|---|---|---|
|
MAS(Modified Ashworth Score) of Elbow Flexor
Baseline
|
2.33 Scores on a MAS Scale
Standard Deviation 0.75
|
2.18 Scores on a MAS Scale
Standard Deviation 0.65
|
|
MAS(Modified Ashworth Score) of Elbow Flexor
Week 4
|
1.26 Scores on a MAS Scale
Standard Deviation 0.73
|
1.30 Scores on a MAS Scale
Standard Deviation 0.58
|
|
MAS(Modified Ashworth Score) of Elbow Flexor
Week 8
|
1.36 Scores on a MAS Scale
Standard Deviation 0.54
|
1.41 Scores on a MAS Scale
Standard Deviation 0.58
|
|
MAS(Modified Ashworth Score) of Elbow Flexor
Week 12
|
1.45 Scores on a MAS Scale
Standard Deviation 0.68
|
1.52 Scores on a MAS Scale
Standard Deviation 0.60
|
|
MAS(Modified Ashworth Score) of Elbow Flexor
Change(Week 4 - Baseline)
|
-1.07 Scores on a MAS Scale
Standard Deviation 0.73
|
-0.87 Scores on a MAS Scale
Standard Deviation 0.71
|
|
MAS(Modified Ashworth Score) of Elbow Flexor
Change(Week 8 - Baseline)
|
-0.97 Scores on a MAS Scale
Standard Deviation 0.74
|
-0.77 Scores on a MAS Scale
Standard Deviation 0.72
|
|
MAS(Modified Ashworth Score) of Elbow Flexor
Change(Week 12 - Baseline)
|
-0.88 Scores on a MAS Scale
Standard Deviation 0.75
|
-0.65 Scores on a MAS Scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8 and week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 82 subjects receiving Meditoxin and 83 Botox.
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).
Outcome measures
| Measure |
Meditoxin®
n=82 Participants
Botulinum toxin type A
|
Botox®
n=83 Participants
Botulinum Toxin type A
|
|---|---|---|
|
MAS(Modified Ashworth Score) of Finger Flexor
Baseline
|
2.37 Score on a MAS Scale
Standard Deviation 0.80
|
2.48 Score on a MAS Scale
Standard Deviation 0.75
|
|
MAS(Modified Ashworth Score) of Finger Flexor
Week 4
|
1.01 Score on a MAS Scale
Standard Deviation 0.67
|
1.05 Score on a MAS Scale
Standard Deviation 0.66
|
|
MAS(Modified Ashworth Score) of Finger Flexor
Week 8
|
1.15 Score on a MAS Scale
Standard Deviation 0.62
|
1.17 Score on a MAS Scale
Standard Deviation 0.66
|
|
MAS(Modified Ashworth Score) of Finger Flexor
Week 12
|
1.20 Score on a MAS Scale
Standard Deviation 0.68
|
1.30 Score on a MAS Scale
Standard Deviation 0.66
|
|
MAS(Modified Ashworth Score) of Finger Flexor
Change(Week 4 - Baseline)
|
-1.36 Score on a MAS Scale
Standard Deviation 0.90
|
-1.42 Score on a MAS Scale
Standard Deviation 0.94
|
|
MAS(Modified Ashworth Score) of Finger Flexor
Change(Week 8 - Baseline)
|
-1.23 Score on a MAS Scale
Standard Deviation 0.89
|
-1.30 Score on a MAS Scale
Standard Deviation 0.91
|
|
MAS(Modified Ashworth Score) of Finger Flexor
Change(Week 12 - Baseline)
|
-1.18 Score on a MAS Scale
Standard Deviation 0.90
|
-1.16 Score on a MAS Scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8 and week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 54 subjects receiving Meditoxin and 58 Botox.
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).
Outcome measures
| Measure |
Meditoxin®
n=54 Participants
Botulinum toxin type A
|
Botox®
n=58 Participants
Botulinum Toxin type A
|
|---|---|---|
|
MAS(Modified Ashworth Score) of Thumb Flexor
Baseline
|
1.94 Scores on a MAS Scale
Standard Deviation 0.73
|
1.94 Scores on a MAS Scale
Standard Deviation 0.74
|
|
MAS(Modified Ashworth Score) of Thumb Flexor
Week 4
|
0.89 Scores on a MAS Scale
Standard Deviation 0.71
|
0.69 Scores on a MAS Scale
Standard Deviation 0.66
|
|
MAS(Modified Ashworth Score) of Thumb Flexor
Week 8
|
1.01 Scores on a MAS Scale
Standard Deviation 0.67
|
0.84 Scores on a MAS Scale
Standard Deviation 0.77
|
|
MAS(Modified Ashworth Score) of Thumb Flexor
Week 12
|
1.06 Scores on a MAS Scale
Standard Deviation 0.84
|
0.96 Scores on a MAS Scale
Standard Deviation 0.69
|
|
MAS(Modified Ashworth Score) of Thumb Flexor
Change(Week 4 - Baseline)
|
-1.06 Scores on a MAS Scale
Standard Deviation 0.85
|
-1.25 Scores on a MAS Scale
Standard Deviation 0.83
|
|
MAS(Modified Ashworth Score) of Thumb Flexor
Change(Week 8 - Baseline)
|
-0.94 Scores on a MAS Scale
Standard Deviation 0.85
|
-1.09 Scores on a MAS Scale
Standard Deviation 0.85
|
|
MAS(Modified Ashworth Score) of Thumb Flexor
Change(Week 12 - Baseline)
|
-0.89 Scores on a MAS Scale
Standard Deviation 0.99
|
-0.98 Scores on a MAS Scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: week 4, week 8, week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox.
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.
Outcome measures
| Measure |
Meditoxin®
n=94 Participants
Botulinum toxin type A
|
Botox®
n=98 Participants
Botulinum Toxin type A
|
|---|---|---|
|
Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor
Week 4
|
77 Subjects who improved 1-point on MAS
|
88 Subjects who improved 1-point on MAS
|
|
Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor
Week 8
|
77 Subjects who improved 1-point on MAS
|
80 Subjects who improved 1-point on MAS
|
|
Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor
Week 12
|
71 Subjects who improved 1-point on MAS
|
77 Subjects who improved 1-point on MAS
|
SECONDARY outcome
Timeframe: week 4, week 8, week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 87 subjects receiving Meditoxin and 94 Botox.
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
Outcome measures
| Measure |
Meditoxin®
n=87 Participants
Botulinum toxin type A
|
Botox®
n=94 Participants
Botulinum Toxin type A
|
|---|---|---|
|
Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor
Week 4
|
56 Subjects who improved 1-point on MAS
|
52 Subjects who improved 1-point on MAS
|
|
Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor
Week 8
|
49 Subjects who improved 1-point on MAS
|
42 Subjects who improved 1-point on MAS
|
|
Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor
Week 12
|
46 Subjects who improved 1-point on MAS
|
39 Subjects who improved 1-point on MAS
|
SECONDARY outcome
Timeframe: week 4, week 8, week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 82 subjects receiving Meditoxin and 83 Botox.
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.
Outcome measures
| Measure |
Meditoxin®
n=82 Participants
Botulinum toxin type A
|
Botox®
n=83 Participants
Botulinum Toxin type A
|
|---|---|---|
|
Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor
Week 12
|
47 Subjects who improved 1-point on MAS
|
54 Subjects who improved 1-point on MAS
|
|
Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor
Week 4
|
58 Subjects who improved 1-point on MAS
|
64 Subjects who improved 1-point on MAS
|
|
Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor
Week 8
|
51 Subjects who improved 1-point on MAS
|
60 Subjects who improved 1-point on MAS
|
SECONDARY outcome
Timeframe: week 4, week 8, week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 54 subjects receiving Meditoxin and 58 Botox.
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.
Outcome measures
| Measure |
Meditoxin®
n=54 Participants
Botulinum toxin type A
|
Botox®
n=58 Participants
Botulinum Toxin type A
|
|---|---|---|
|
Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor
Week 4
|
34 Subjects who improved 1-point on MAS
|
41 Subjects who improved 1-point on MAS
|
|
Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor
Week 8
|
28 Subjects who improved 1-point on MAS
|
37 Subjects who improved 1-point on MAS
|
|
Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor
Week 12
|
27 Subjects who improved 1-point on MAS
|
30 Subjects who improved 1-point on MAS
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8 and week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 39 subjects receiving Meditoxin and 34 Botox.
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).
Outcome measures
| Measure |
Meditoxin®
n=39 Participants
Botulinum toxin type A
|
Botox®
n=34 Participants
Botulinum Toxin type A
|
|---|---|---|
|
DAS(Disability Assessment Scale) of Hygiene
Baseline
|
2.62 Scores on a DAS Scale
Standard Deviation 0.49
|
2.74 Scores on a DAS Scale
Standard Deviation 0.45
|
|
DAS(Disability Assessment Scale) of Hygiene
Week 4
|
1.90 Scores on a DAS Scale
Standard Deviation 1.02
|
2.09 Scores on a DAS Scale
Standard Deviation 0.87
|
|
DAS(Disability Assessment Scale) of Hygiene
Week 8
|
1.85 Scores on a DAS Scale
Standard Deviation 0.99
|
2.12 Scores on a DAS Scale
Standard Deviation 0.88
|
|
DAS(Disability Assessment Scale) of Hygiene
Week 12
|
1.87 Scores on a DAS Scale
Standard Deviation 0.98
|
2.12 Scores on a DAS Scale
Standard Deviation 0.84
|
|
DAS(Disability Assessment Scale) of Hygiene
Change(Week 4 - Baseline)
|
-0.72 Scores on a DAS Scale
Standard Deviation 0.79
|
-0.65 Scores on a DAS Scale
Standard Deviation 0.65
|
|
DAS(Disability Assessment Scale) of Hygiene
Change(Week 8 - Baseline)
|
-0.77 Scores on a DAS Scale
Standard Deviation 0.67
|
-0.62 Scores on a DAS Scale
Standard Deviation 0.65
|
|
DAS(Disability Assessment Scale) of Hygiene
Change(Week 12 - Baseline)
|
-0.74 Scores on a DAS Scale
Standard Deviation 0.75
|
-0.62 Scores on a DAS Scale
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8 and week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 11 subjects receiving Meditoxin and 15 Botox.
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).
Outcome measures
| Measure |
Meditoxin®
n=11 Participants
Botulinum toxin type A
|
Botox®
n=15 Participants
Botulinum Toxin type A
|
|---|---|---|
|
DAS(Disability Assessment Scale) of Dressing
Baseline
|
2.09 Scores on a DAS Scale
Standard Deviation 0.30
|
2.13 Scores on a DAS Scale
Standard Deviation 0.35
|
|
DAS(Disability Assessment Scale) of Dressing
Week 4
|
1.30 Scores on a DAS Scale
Standard Deviation 0.67
|
1.07 Scores on a DAS Scale
Standard Deviation 0.47
|
|
DAS(Disability Assessment Scale) of Dressing
Week 8
|
1.36 Scores on a DAS Scale
Standard Deviation 0.50
|
1.00 Scores on a DAS Scale
Standard Deviation 0.55
|
|
DAS(Disability Assessment Scale) of Dressing
Week 12
|
1.27 Scores on a DAS Scale
Standard Deviation 0.65
|
1.00 Scores on a DAS Scale
Standard Deviation 0.55
|
|
DAS(Disability Assessment Scale) of Dressing
Change(Week 4 - Baseline)
|
-0.70 Scores on a DAS Scale
Standard Deviation 0.67
|
-1.07 Scores on a DAS Scale
Standard Deviation 0.47
|
|
DAS(Disability Assessment Scale) of Dressing
Change(Week 8 - Baseline)
|
-0.73 Scores on a DAS Scale
Standard Deviation 0.47
|
-1.14 Scores on a DAS Scale
Standard Deviation 0.66
|
|
DAS(Disability Assessment Scale) of Dressing
Change(Week 12 - Baseline)
|
-0.82 Scores on a DAS Scale
Standard Deviation 0.60
|
-1.14 Scores on a DAS Scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8 and week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 40 subjects receiving Meditoxin and 47 Botox.
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).
Outcome measures
| Measure |
Meditoxin®
n=40 Participants
Botulinum toxin type A
|
Botox®
n=47 Participants
Botulinum Toxin type A
|
|---|---|---|
|
DAS(Disability Assessment Scale) of Limb Position
Baseline
|
2.50 Scores on a DAS Scale
Standard Deviation 0.51
|
2.45 Scores on a DAS Scale
Standard Deviation 0.50
|
|
DAS(Disability Assessment Scale) of Limb Position
Week 4
|
1.28 Scores on a DAS Scale
Standard Deviation 0.55
|
1.29 Scores on a DAS Scale
Standard Deviation 0.54
|
|
DAS(Disability Assessment Scale) of Limb Position
Week 8
|
1.27 Scores on a DAS Scale
Standard Deviation 0.55
|
1.25 Scores on a DAS Scale
Standard Deviation 0.53
|
|
DAS(Disability Assessment Scale) of Limb Position
Week 12
|
1.29 Scores on a DAS Scale
Standard Deviation 0.56
|
1.23 Scores on a DAS Scale
Standard Deviation 0.47
|
|
DAS(Disability Assessment Scale) of Limb Position
Change(Week 4 - Baseline)
|
-1.23 Scores on a DAS Scale
Standard Deviation 0.62
|
-1.15 Scores on a DAS Scale
Standard Deviation 0.55
|
|
DAS(Disability Assessment Scale) of Limb Position
Change(Week 8 - Baseline)
|
-1.23 Scores on a DAS Scale
Standard Deviation 0.66
|
-1.19 Scores on a DAS Scale
Standard Deviation 0.54
|
|
DAS(Disability Assessment Scale) of Limb Position
Change(Week 12 - Baseline)
|
-1.20 Scores on a DAS Scale
Standard Deviation 0.69
|
-1.21 Scores on a DAS Scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8 and week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 4 subjects receiving Meditoxin and 2 Botox.
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).
Outcome measures
| Measure |
Meditoxin®
n=4 Participants
Botulinum toxin type A
|
Botox®
n=2 Participants
Botulinum Toxin type A
|
|---|---|---|
|
DAS(Disability Assessment Scale) of Pain
Baseline
|
2.00 Scores on a DAS Scale
Standard Deviation 0.00
|
2.00 Scores on a DAS Scale
Standard Deviation 0.00
|
|
DAS(Disability Assessment Scale) of Pain
Week 4
|
1.25 Scores on a DAS Scale
Standard Deviation 0.50
|
1.00 Scores on a DAS Scale
Standard Deviation 0.00
|
|
DAS(Disability Assessment Scale) of Pain
Week 8
|
0.75 Scores on a DAS Scale
Standard Deviation 0.50
|
1.00 Scores on a DAS Scale
Standard Deviation 0.00
|
|
DAS(Disability Assessment Scale) of Pain
Week 12
|
0.50 Scores on a DAS Scale
Standard Deviation 0.58
|
0.00 Scores on a DAS Scale
Standard Deviation 0.00
|
|
DAS(Disability Assessment Scale) of Pain
Change(Week 4 - Baseline)
|
-0.75 Scores on a DAS Scale
Standard Deviation 0.50
|
-1.00 Scores on a DAS Scale
Standard Deviation 0.00
|
|
DAS(Disability Assessment Scale) of Pain
Change(Week 8 - Baseline)
|
-1.25 Scores on a DAS Scale
Standard Deviation 0.50
|
-1.00 Scores on a DAS Scale
Standard Deviation 0.00
|
|
DAS(Disability Assessment Scale) of Pain
Change(Week 12 - Baseline)
|
-1.50 Scores on a DAS Scale
Standard Deviation 0.58
|
-2.00 Scores on a DAS Scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox.
Global assessment evaluated by investigator at week 12 after injection
Outcome measures
| Measure |
Meditoxin®
n=94 Participants
Botulinum toxin type A
|
Botox®
n=98 Participants
Botulinum Toxin type A
|
|---|---|---|
|
Global Assessment by Investigator
Good
|
63 participants
|
56 participants
|
|
Global Assessment by Investigator
Very good
|
19 participants
|
19 participants
|
|
Global Assessment by Investigator
Moderate
|
10 participants
|
18 participants
|
|
Global Assessment by Investigator
Insufficient
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox.
Global assessment evaluated by patient or caregiver at week 12 after injection
Outcome measures
| Measure |
Meditoxin®
n=94 Participants
Botulinum toxin type A
|
Botox®
n=98 Participants
Botulinum Toxin type A
|
|---|---|---|
|
Global Assessment by Patient or Caregiver
Very good
|
11 participants
|
10 participants
|
|
Global Assessment by Patient or Caregiver
Good
|
39 participants
|
44 participants
|
|
Global Assessment by Patient or Caregiver
Moderate
|
36 participants
|
35 participants
|
|
Global Assessment by Patient or Caregiver
Insufficient
|
7 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8 and week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox.
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).
Outcome measures
| Measure |
Meditoxin®
n=92 Participants
Botulinum toxin type A
|
Botox®
n=98 Participants
Botulinum Toxin type A
|
|---|---|---|
|
Carer Burden Scale of Cleaning the Palm
Baseline
|
1.70 Score on a Carer Burden Scale
Standard Deviation 1.16
|
1.67 Score on a Carer Burden Scale
Standard Deviation 1.17
|
|
Carer Burden Scale of Cleaning the Palm
Week 4
|
1.26 Score on a Carer Burden Scale
Standard Deviation 1.02
|
1.34 Score on a Carer Burden Scale
Standard Deviation 1.00
|
|
Carer Burden Scale of Cleaning the Palm
Week 8
|
1.24 Score on a Carer Burden Scale
Standard Deviation 0.96
|
1.40 Score on a Carer Burden Scale
Standard Deviation 1.09
|
|
Carer Burden Scale of Cleaning the Palm
Week 12
|
1.18 Score on a Carer Burden Scale
Standard Deviation 1.05
|
1.44 Score on a Carer Burden Scale
Standard Deviation 1.09
|
|
Carer Burden Scale of Cleaning the Palm
Change(Week 4 - Baseline)
|
-0.40 Score on a Carer Burden Scale
Standard Deviation 1.29
|
-0.34 Score on a Carer Burden Scale
Standard Deviation 1.10
|
|
Carer Burden Scale of Cleaning the Palm
Change(Week 8 - Baseline)
|
-0.46 Score on a Carer Burden Scale
Standard Deviation 1.24
|
-0.28 Score on a Carer Burden Scale
Standard Deviation 1.09
|
|
Carer Burden Scale of Cleaning the Palm
Change(Week 12 - Baseline)
|
-0.51 Score on a Carer Burden Scale
Standard Deviation 1.34
|
-0.23 Score on a Carer Burden Scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8 and week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox.
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).
Outcome measures
| Measure |
Meditoxin®
n=92 Participants
Botulinum toxin type A
|
Botox®
n=98 Participants
Botulinum Toxin type A
|
|---|---|---|
|
Carer Burden Scale of Cutting the Finger-nails
Baseline
|
2.08 Scores on a Carer Burden Scale
Standard Deviation 1.34
|
2.22 Scores on a Carer Burden Scale
Standard Deviation 1.27
|
|
Carer Burden Scale of Cutting the Finger-nails
Week 4
|
1.58 Scores on a Carer Burden Scale
Standard Deviation 1.30
|
1.89 Scores on a Carer Burden Scale
Standard Deviation 1.32
|
|
Carer Burden Scale of Cutting the Finger-nails
Week 8
|
1.57 Scores on a Carer Burden Scale
Standard Deviation 1.25
|
1.84 Scores on a Carer Burden Scale
Standard Deviation 1.37
|
|
Carer Burden Scale of Cutting the Finger-nails
Week 12
|
1.59 Scores on a Carer Burden Scale
Standard Deviation 1.32
|
1.81 Scores on a Carer Burden Scale
Standard Deviation 1.35
|
|
Carer Burden Scale of Cutting the Finger-nails
Change(Week 4 - Baseline)
|
-0.47 Scores on a Carer Burden Scale
Standard Deviation 1.26
|
-0.34 Scores on a Carer Burden Scale
Standard Deviation 1.17
|
|
Carer Burden Scale of Cutting the Finger-nails
Change(Week 8 - Baseline)
|
-0.51 Scores on a Carer Burden Scale
Standard Deviation 1.29
|
-0.39 Scores on a Carer Burden Scale
Standard Deviation 1.25
|
|
Carer Burden Scale of Cutting the Finger-nails
Change(Week 12 - Baseline)
|
-0.49 Scores on a Carer Burden Scale
Standard Deviation 1.35
|
-0.42 Scores on a Carer Burden Scale
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8 and week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox.
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).
Outcome measures
| Measure |
Meditoxin®
n=92 Participants
Botulinum toxin type A
|
Botox®
n=98 Participants
Botulinum Toxin type A
|
|---|---|---|
|
Carer Burden Scale of Putting Shirts on
Baseline
|
1.79 Scores on a Carer Burden Scale
Standard Deviation 1.00
|
1.64 Scores on a Carer Burden Scale
Standard Deviation 1.11
|
|
Carer Burden Scale of Putting Shirts on
Week 4
|
1.46 Scores on a Carer Burden Scale
Standard Deviation 0.97
|
1.42 Scores on a Carer Burden Scale
Standard Deviation 1.10
|
|
Carer Burden Scale of Putting Shirts on
Week 8
|
1.34 Scores on a Carer Burden Scale
Standard Deviation 0.96
|
1.28 Scores on a Carer Burden Scale
Standard Deviation 0.97
|
|
Carer Burden Scale of Putting Shirts on
Week 12
|
1.32 Scores on a Carer Burden Scale
Standard Deviation 1.05
|
1.30 Scores on a Carer Burden Scale
Standard Deviation 1.07
|
|
Carer Burden Scale of Putting Shirts on
Change(Week 4 - Baseline)
|
-0.32 Scores on a Carer Burden Scale
Standard Deviation 1.12
|
-0.22 Scores on a Carer Burden Scale
Standard Deviation 0.98
|
|
Carer Burden Scale of Putting Shirts on
Change(Week 8 - Baseline)
|
-0.46 Scores on a Carer Burden Scale
Standard Deviation 1.11
|
-0.37 Scores on a Carer Burden Scale
Standard Deviation 1.17
|
|
Carer Burden Scale of Putting Shirts on
Change(Week 12 - Baseline)
|
-0.48 Scores on a Carer Burden Scale
Standard Deviation 1.13
|
-0.35 Scores on a Carer Burden Scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8 and week 12Population: The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox.
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).
Outcome measures
| Measure |
Meditoxin®
n=92 Participants
Botulinum toxin type A
|
Botox®
n=98 Participants
Botulinum Toxin type A
|
|---|---|---|
|
Carer Burden Scale of Cleaning the Armpit
Change(Week 8 - Baseline)
|
-0.48 Scores on a Carer Burden Scale
Standard Deviation 1.12
|
-0.38 Scores on a Carer Burden Scale
Standard Deviation 1.26
|
|
Carer Burden Scale of Cleaning the Armpit
Change(Week 12 - Baseline)
|
-0.55 Scores on a Carer Burden Scale
Standard Deviation 1.19
|
-0.28 Scores on a Carer Burden Scale
Standard Deviation 1.43
|
|
Carer Burden Scale of Cleaning the Armpit
Baseline
|
1.98 Scores on a Carer Burden Scale
Standard Deviation 1.21
|
1.97 Scores on a Carer Burden Scale
Standard Deviation 1.27
|
|
Carer Burden Scale of Cleaning the Armpit
Week 4
|
1.56 Scores on a Carer Burden Scale
Standard Deviation 1.15
|
1.71 Scores on a Carer Burden Scale
Standard Deviation 1.26
|
|
Carer Burden Scale of Cleaning the Armpit
Week 8
|
1.50 Scores on a Carer Burden Scale
Standard Deviation 1.16
|
1.59 Scores on a Carer Burden Scale
Standard Deviation 1.29
|
|
Carer Burden Scale of Cleaning the Armpit
Week 12
|
1.42 Scores on a Carer Burden Scale
Standard Deviation 1.15
|
1.69 Scores on a Carer Burden Scale
Standard Deviation 1.33
|
|
Carer Burden Scale of Cleaning the Armpit
Change(Week 4 - Baseline)
|
-0.39 Scores on a Carer Burden Scale
Standard Deviation 1.12
|
-0.26 Scores on a Carer Burden Scale
Standard Deviation 1.20
|
Adverse Events
Meditoxin®
Serious events: 5 serious events
Other events: 35 other events
Deaths: 0 deaths
Botox®
Serious events: 8 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Meditoxin®
n=98 participants at risk
Botulinum toxin type A
|
Botox®
n=98 participants at risk
Botulinum Toxin type A
|
|---|---|---|
|
Hepatobiliary disorders
Hepatitis toxic
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.0%
2/98 • Number of events 2 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
2.0%
2/98 • Number of events 2 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Immune system disorders
Behcet's syndrome
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Infections and infestations
Pneumonia
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Infections and infestations
Pulmonary tuberculosis
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Renal and urinary disorders
Renal failure
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
Other adverse events
| Measure |
Meditoxin®
n=98 participants at risk
Botulinum toxin type A
|
Botox®
n=98 participants at risk
Botulinum Toxin type A
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
3/98 • Number of events 4 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
2.0%
2/98 • Number of events 2 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
3/98 • Number of events 4 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
2/98 • Number of events 2 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
2/98 • Number of events 2 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
2/98 • Number of events 2 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Gastrointestinal disorders
Consitipation
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
3.1%
3/98 • Number of events 3 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Infections and infestations
Nasopharyngitis
|
4.1%
4/98 • Number of events 5 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
4.1%
4/98 • Number of events 4 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
2/98 • Number of events 2 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
5.1%
5/98 • Number of events 6 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.1%
4/98 • Number of events 5 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
3/98 • Number of events 3 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
2/98 • Number of events 2 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
General disorders
Oedema peripheral
|
3.1%
3/98 • Number of events 3 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
General disorders
Injection site haematoma
|
2.0%
2/98 • Number of events 2 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
General disorders
Pyrexia
|
2.0%
2/98 • Number of events 2 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
2.0%
2/98 • Number of events 2 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
2.0%
2/98 • Number of events 2 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.0%
2/98 • Number of events 2 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
2.0%
2/98 • Number of events 2 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Nervous system disorders
Convulsion
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
3.1%
3/98 • Number of events 5 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Nervous system disorders
Dizziness
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
3.1%
3/98 • Number of events 4 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Nervous system disorders
Headache
|
1.0%
1/98 • Number of events 1 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
3.1%
3/98 • Number of events 3 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/98 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
2.0%
2/98 • Number of events 2 • The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
|
Additional Information
Medytox Inc.
Clinical Development Team of Medytox Inc.
Phone: 82-70-8666-6911
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All the results which arise directly or indirectly from the clinical trial in any form shall be the exclusive property of the sponsor. PIs and the sponsor will discuss, prior to public release of the results, any draft publication or communication made by the investigator. PIs shall not mention any information for a patent or for any intellectual property rights. The sponsor may use or explit all the results at its own discretion, without any limitation to its property right.
- Publication restrictions are in place
Restriction type: OTHER