Trial Outcomes & Findings for Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke (NCT NCT01392300)
NCT ID: NCT01392300
Last Updated: 2017-01-16
Results Overview
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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).
COMPLETED
PHASE3
317 participants
Week 4
2017-01-16
Participant Flow
Participant milestones
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
OLEX IncobotulinumtoxinA (Xeomin) (400 Units, 3 Injections)
IncobotulinumtoxinA (Xeomin) (400 Units): OLEX period, three injection sessions - open-label treatment assignment
|
|---|---|---|---|
|
Main Period (MP)
STARTED
|
210
|
107
|
0
|
|
Main Period (MP)
COMPLETED
|
199
|
100
|
0
|
|
Main Period (MP)
NOT COMPLETED
|
11
|
7
|
0
|
|
Open Label Extension (OLEX) Period
STARTED
|
0
|
0
|
299
|
|
Open Label Extension (OLEX) Period
COMPLETED
|
0
|
0
|
248
|
|
Open Label Extension (OLEX) Period
NOT COMPLETED
|
0
|
0
|
51
|
Reasons for withdrawal
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
OLEX IncobotulinumtoxinA (Xeomin) (400 Units, 3 Injections)
IncobotulinumtoxinA (Xeomin) (400 Units): OLEX period, three injection sessions - open-label treatment assignment
|
|---|---|---|---|
|
Main Period (MP)
Predefined discontinuation criteria
|
2
|
3
|
0
|
|
Main Period (MP)
Withdrawal by Subject
|
5
|
1
|
0
|
|
Main Period (MP)
Lost to Follow-up
|
3
|
3
|
0
|
|
Main Period (MP)
Non-compliance
|
1
|
0
|
0
|
|
Open Label Extension (OLEX) Period
Protocol Violation
|
0
|
0
|
13
|
|
Open Label Extension (OLEX) Period
Lack of Efficacy
|
0
|
0
|
3
|
|
Open Label Extension (OLEX) Period
Non-compliance
|
0
|
0
|
1
|
|
Open Label Extension (OLEX) Period
Death
|
0
|
0
|
4
|
|
Open Label Extension (OLEX) Period
Adverse Event
|
0
|
0
|
7
|
|
Open Label Extension (OLEX) Period
Withdrawal by Subject
|
0
|
0
|
17
|
|
Open Label Extension (OLEX) Period
Lost to Follow-up
|
0
|
0
|
6
|
Baseline Characteristics
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke
Baseline characteristics by cohort
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=210 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=107 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Total
n=317 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Gender
Female
|
120 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Gender
Male
|
90 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
184 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
175 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
12 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
46 participants
n=5 Participants
|
25 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
23 participants
n=5 Participants
|
9 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
66 participants
n=5 Participants
|
38 participants
n=7 Participants
|
104 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
22 participants
n=5 Participants
|
10 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
India
|
26 participants
n=5 Participants
|
13 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern
|
-0.9 units on a scale
Standard Error 0.06
|
-0.5 units on a scale
Standard Error 0.08
|
PRIMARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by zero change (worst case).
This is the co-primary outcome measure. The Global Impression of Change Scale \[GICS\] is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Investigator's Global Impression of Change
|
1.2 units on a scale
Standard Error 0.07
|
0.9 units on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern
|
119 participants
|
33 participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern
|
104 participants
|
34 participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern
|
68 participants
|
22 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist
|
102 participants
|
31 participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist
|
90 participants
|
33 participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist
|
59 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow
|
99 participants
|
28 participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow
|
85 participants
|
28 participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow
|
52 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist
|
90 participants
|
26 participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist
|
82 participants
|
27 participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist
|
49 participants
|
19 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm
|
56 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm
|
52 participants
|
23 participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm
|
35 participants
|
20 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm
|
73 participants
|
19 participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm
|
64 participants
|
20 participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Outcome measures
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm
|
51 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
|
-0.8 units on a scale
Standard Error 0.06
|
-0.5 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
|
-0.6 units on a scale
Standard Error 0.06
|
-0.4 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
|
-0.3 units on a scale
Standard Error 0.05
|
-0.1 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
|
-0.7 units on a scale
Standard Error 0.05
|
-0.3 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
|
-0.6 units on a scale
Standard Error 0.05
|
-0.3 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
|
-0.4 units on a scale
Standard Error 0.05
|
-0.2 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
|
-0.7 units on a scale
Standard Error 0.06
|
-0.3 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
|
-0.6 units on a scale
Standard Error 0.05
|
-0.4 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
|
-0.3 units on a scale
Standard Error 0.05
|
-0.1 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
|
-0.4 units on a scale
Standard Error 0.05
|
-0.2 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
|
-0.3 units on a scale
Standard Error 0.05
|
-0.2 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
|
-0.2 units on a scale
Standard Error 0.05
|
-0.1 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
|
-0.5 units on a scale
Standard Error 0.05
|
-0.2 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
|
-0.4 units on a scale
Standard Error 0.05
|
-0.2 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
|
-0.3 units on a scale
Standard Error 0.05
|
-0.1 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain
|
-0.5 units on a scale
Standard Error 0.05
|
-0.3 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain
|
-0.5 units on a scale
Standard Error 0.05
|
-0.3 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain
|
-0.4 units on a scale
Standard Error 0.05
|
-0.4 units on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene
|
-0.4 units on a scale
Standard Error 0.05
|
-0.1 units on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene
|
-0.4 units on a scale
Standard Error 0.05
|
-0.2 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene
|
-0.3 units on a scale
Standard Error 0.05
|
-0.1 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing
|
-0.4 units on a scale
Standard Error 0.05
|
-0.2 units on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing
|
-0.4 units on a scale
Standard Error 0.05
|
-0.2 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing
|
-0.3 units on a scale
Standard Error 0.04
|
-0.1 units on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position
|
-0.5 units on a scale
Standard Error 0.05
|
-0.3 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position
|
-0.4 units on a scale
Standard Error 0.05
|
-0.2 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position
|
-0.4 units on a scale
Standard Error 0.05
|
-0.3 units on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain
|
-0.2 units on a scale
Standard Error 0.06
|
-0.2 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain
|
-0.2 units on a scale
Standard Error 0.06
|
-0.2 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
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 |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=171 Participants
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=88 Participants
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
|---|---|---|
|
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain
|
-0.3 units on a scale
Standard Error 0.06
|
-0.2 units on a scale
Standard Error 0.09
|
Adverse Events
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
Double-blind Placebo Comparator
OLEX IncoboutulinumtoxinA (Xeomin) (400 Units, 3 Injections)
Serious adverse events
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=210 participants at risk
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=107 participants at risk
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
OLEX IncoboutulinumtoxinA (Xeomin) (400 Units, 3 Injections)
n=296 participants at risk
IncobotulinumtoxinA (Xeomin) (400 Units): OLEX period, three injection sessions - open-label treatment assignment
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.48%
1/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.68%
2/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Infections and infestations
Urinary tract infection
|
0.48%
1/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Infections and infestations
Urosepsis
|
0.48%
1/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Vascular disorders
Peipheral ischaemia
|
0.95%
2/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Gastrointestinal disorders
Pancreatic enlargement
|
0.48%
1/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Hepatobiliary disorders
Biliary colic
|
0.48%
1/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Nervous system disorders
Epilepsy
|
0.48%
1/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.68%
2/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.93%
1/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.93%
1/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Vascular disorders
Hypertension
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
General disorders
Cardiac death
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Psychiatric disorders
Depression
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Nervous system disorders
Headache
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Nervous system disorders
Pseudobulbar palsy
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Eye disorders
Glaucoma
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Infections and infestations
Sepsis
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Infections and infestations
Septic shock
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.34%
1/296 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
Other adverse events
| Measure |
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)
n=210 participants at risk
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
Double-blind Placebo Comparator
n=107 participants at risk
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
|
OLEX IncoboutulinumtoxinA (Xeomin) (400 Units, 3 Injections)
n=296 participants at risk
IncobotulinumtoxinA (Xeomin) (400 Units): OLEX period, three injection sessions - open-label treatment assignment
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.48%
1/210 • Number of events 1 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
2.8%
3/107 • Number of events 6 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
1.0%
3/296 • Number of events 6 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Investigations
Blood glucose increased
|
0.48%
1/210 • Number of events 1 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
2.7%
8/296 • Number of events 9 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Investigations
International normalised ratio increased
|
0.48%
1/210 • Number of events 1 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
2.7%
8/296 • Number of events 10 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/210 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.93%
1/107 • Number of events 1 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
2.4%
7/296 • Number of events 9 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
|
Nervous system disorders
Epilepsy
|
2.4%
5/210 • Number of events 6 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/107 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
2.0%
6/296 • Number of events 8 • From the timepoint of first injection until 12 weeks +/- 3 days after last injection
The investigator asked the patient for AEs systematically at each visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
- Publication restrictions are in place
Restriction type: OTHER