Trial Outcomes & Findings for IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity (NCT NCT00465738)
NCT ID: NCT00465738
Last Updated: 2010-12-31
Results Overview
The primary efficacy endpoint is the number of responder at Week 4; response defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit to Week 4. The DAS determines the functional impairment for the domains hygiene, dressing, limb position and pain according to the following scale: 0 = no disability; 1 = mild disability; 2 = moderate disability; 3 = severe disability. At Screening visit, the subject and investigator, selected together one of the four domains as the primary therapeutic target.
COMPLETED
PHASE3
216 participants
At week 4
2010-12-31
Participant Flow
216 female and male subjects with upper limb spasticity caused by either stroke, brain injury, spinal cord injury, multiple sclerosis or cerebral palsy were screened starting February 2007. Recruitment advertisements according to local law and approved by the responsible IEC were published as needed.
The protocol contained a screening period of 7 days to allow evaluation of laboratory and ECGs in order to determine eligibility. 24 subjects were screening failures due to violation of selection or protocol criteria.
Participant milestones
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
95
|
|
Overall Study
COMPLETED
|
91
|
89
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Other
|
2
|
5
|
Baseline Characteristics
IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity
Baseline characteristics by cohort
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=97 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
55.3 years
STANDARD_DEVIATION 14.88 • n=93 Participants
|
55.5 years
STANDARD_DEVIATION 13.74 • n=4 Participants
|
55.4 years
STANDARD_DEVIATION 14.29 • n=27 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
81 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
111 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
76 participants
n=93 Participants
|
78 participants
n=4 Participants
|
154 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Negroid
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Missing
|
18 participants
n=93 Participants
|
16 participants
n=4 Participants
|
34 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: At week 4Population: Analysis is based on Per Protocol Set, defined as all randomized subjects who received at least one dose of study drug and who have no major deviation from study protocol. For this set of subjects no missing values can occur for the primary endpoint.
The primary efficacy endpoint is the number of responder at Week 4; response defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit to Week 4. The DAS determines the functional impairment for the domains hygiene, dressing, limb position and pain according to the following scale: 0 = no disability; 1 = mild disability; 2 = moderate disability; 3 = severe disability. At Screening visit, the subject and investigator, selected together one of the four domains as the primary therapeutic target.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=81 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=84 Participants
|
|---|---|---|
|
Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set
|
51 participants
|
44 participants
|
SECONDARY outcome
Timeframe: week 4Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=94 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Responder in DAS at Week 4 - Full Analysis Set
|
59 participants
|
49 participants
|
SECONDARY outcome
Timeframe: week 12Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=94 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Responder in DAS at Week 12 - Full Analysis Set
|
46 participants
|
38 participants
|
SECONDARY outcome
Timeframe: follow up visit, between week 12 and week 20Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=75 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=71 Participants
|
|---|---|---|
|
Responder in DAS at Follow up - Full Analysis Set
|
40 participants
|
33 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=94 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set
|
17 participants
|
24 participants
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=94 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Responder in FAT at Week 12 - Full Analysis Set
|
20 participants
|
22 participants
|
SECONDARY outcome
Timeframe: follow up visit, between week 12 and week 20Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=75 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=71 Participants
|
|---|---|---|
|
Responder in FAT at Follow up - Full Analysis Set
|
12 participants
|
15 participants
|
SECONDARY outcome
Timeframe: week 4Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. The Ashworth Scale is a 5-point-scale to rate to degree of spasticity: 0 = No increase in tone; 1 = Slight increase in tone giving a "catch" when the limb was moved in flexion or extension; 2 = More marked increase in tone, but limb easily flexed; 3 = Considerable increase in tone - passive movements difficult; 4 = Limb rigid in flexion or extension.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=75 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=81 Participants
|
|---|---|---|
|
Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set
|
47 participants
|
50 participants
|
SECONDARY outcome
Timeframe: week 12Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=75 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=81 Participants
|
|---|---|---|
|
Responder in Ashworth Scale (Elbow Flexors) at Week 12 - Full Analysis Set
|
37 participants
|
40 participants
|
SECONDARY outcome
Timeframe: follow up visit, between week 12 and week 20Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=59 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=62 Participants
|
|---|---|---|
|
Responder in Ashworth Scale (Elbow Flexors) at Follow up - Full Analysis Set
|
30 participants
|
21 participants
|
SECONDARY outcome
Timeframe: week 4Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=87 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=89 Participants
|
|---|---|---|
|
Responder in Ashworth Scale (Wrist Flexors) at Week 4 - Full Analysis Set
|
68 participants
|
63 participants
|
SECONDARY outcome
Timeframe: week 12Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=87 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=89 Participants
|
|---|---|---|
|
Responder in Ashworth Scale (Wrist Flexors) at Week 12 - Full Analysis Set
|
43 participants
|
46 participants
|
SECONDARY outcome
Timeframe: follow up visit, between week 12 and week 20Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=69 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=67 Participants
|
|---|---|---|
|
Responder in Ashworth Scale (Wrist Flexors) at Follow up - Full Analysis Set
|
31 participants
|
28 participants
|
SECONDARY outcome
Timeframe: week 4Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=35 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=32 Participants
|
|---|---|---|
|
Responder in Ashworth Scale (Thumb Flexors) at Week 4 - Full Analysis Set
|
29 participants
|
19 participants
|
SECONDARY outcome
Timeframe: week 12Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=35 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=32 Participants
|
|---|---|---|
|
Responder in Ashworth Scale (Thumb Flexors) at Week 12 - Full Analysis Set
|
21 participants
|
13 participants
|
SECONDARY outcome
Timeframe: follow up visit, between week 12 and week 20Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=30 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=23 Participants
|
|---|---|---|
|
Responder in Ashworth Scale (Thumb Flexors) at Follow up - Full Analysis Set
|
18 participants
|
9 participants
|
SECONDARY outcome
Timeframe: week 4Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=78 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=81 Participants
|
|---|---|---|
|
Responder in Ashworth Scale (Fingers Flexors) at Week 4 - Full Analysis Set
|
57 participants
|
48 participants
|
SECONDARY outcome
Timeframe: week 12Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=78 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=81 Participants
|
|---|---|---|
|
Responder in Ashworth Scale (Fingers Flexors) at Week 12 - Full Analysis Set
|
35 participants
|
35 participants
|
SECONDARY outcome
Timeframe: follow up visit, between week 12 and week 20Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=62 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=60 Participants
|
|---|---|---|
|
Responder in Ashworth Scale (Fingers Flexors) at Follow up - Full Analysis Set
|
17 participants
|
20 participants
|
SECONDARY outcome
Timeframe: week 4Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=42 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=46 Participants
|
|---|---|---|
|
Responder in Ashworth Scale (Forearm Pronators) at Week 4 - Full Analysis Set
|
32 participants
|
30 participants
|
SECONDARY outcome
Timeframe: week 12Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=42 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=46 Participants
|
|---|---|---|
|
Responder in Ashworth Scale (Forearm Pronators) at Week 12 - Full Analysis Set
|
28 participants
|
22 participants
|
SECONDARY outcome
Timeframe: follow up visit, between week 12 and week 20Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=34 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=36 Participants
|
|---|---|---|
|
Responder in Ashworth Scale (Forearm Pronators) at Follow up - Full Analysis Set
|
18 participants
|
16 participants
|
SECONDARY outcome
Timeframe: baseline, week 4, week 12, follow up (between week 12 and week 20)Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=97 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Change From Baseline in Passive Range of Motion (PROM) - Wrist Extension
Week 4
|
14.8 degree
Standard Error 3.31 • Interval -10.3 to 8.7
|
15.7 degree
Standard Error 3.47 • Interval -10.3 to 8.7
|
|
Change From Baseline in Passive Range of Motion (PROM) - Wrist Extension
Week 12
|
7.3 degree
Standard Error 3.15 • Interval -12.2 to 5.9
|
10.4 degree
Standard Error 3.32 • Interval -12.2 to 5.9
|
|
Change From Baseline in Passive Range of Motion (PROM) - Wrist Extension
Follow up (between week 12 and week 20)
|
8.2 degree
Standard Error 4.62 • Interval -15.6 to 11.2
|
10.4 degree
Standard Error 4.93 • Interval -15.6 to 11.2
|
SECONDARY outcome
Timeframe: baseline, week 4, week 12, follow up (between week 12 and week 20)Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=97 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Change From Baseline in Passive Range of Motion (PROM) - Elbow Extension
Week 4
|
8.0 degree
Standard Error 3.37 • Interval -7.3 to 11.7
|
5.8 degree
Standard Error 3.42 • Interval -7.3 to 11.7
|
|
Change From Baseline in Passive Range of Motion (PROM) - Elbow Extension
Week 12
|
6.1 degree
Standard Error 4.50 • Interval -8.5 to 16.6
|
2.1 degree
Standard Error 4.46 • Interval -8.5 to 16.6
|
|
Change From Baseline in Passive Range of Motion (PROM) - Elbow Extension
Follow up (between week 12 and week 20)
|
3.9 degree
Standard Error 3.58 • Interval -10.3 to 9.8
|
4.1 degree
Standard Error 3.58 • Interval -10.3 to 9.8
|
SECONDARY outcome
Timeframe: baseline, week 4, week 12, follow up (between week 12 and week 20)Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=97 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Change From Baseline in Passive Range of Motion (PROM) - Wrist Maximum Flexion
Week 4
|
-1.2 degree
Standard Error 2.34 • Interval -13.1 to 0.3
|
5.2 degree
Standard Error 2.45 • Interval -13.1 to 0.3
|
|
Change From Baseline in Passive Range of Motion (PROM) - Wrist Maximum Flexion
Week 12
|
-1.3 degree
Standard Error 2.48 • Interval -11.3 to 3.0
|
2.9 degree
Standard Error 2.62 • Interval -11.3 to 3.0
|
|
Change From Baseline in Passive Range of Motion (PROM) - Wrist Maximum Flexion
Follow up (between week 12 and week 20)
|
-1.3 degree
Standard Error 2.62 • Interval -12.7 to 2.5
|
3.8 degree
Standard Error 2.80 • Interval -12.7 to 2.5
|
SECONDARY outcome
Timeframe: baseline, week 4, week 12, follow up (between week 12 and week 20)Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=97 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Change From Baseline in Passive Range of Motion (PROM) - Elbow Maximum Flexion
Week 4
|
0.1 degree
Standard Error 2.60 • Interval -9.9 to 4.6
|
2.7 degree
Standard Error 2.60 • Interval -9.9 to 4.6
|
|
Change From Baseline in Passive Range of Motion (PROM) - Elbow Maximum Flexion
Week 12
|
-0.7 degree
Standard Error 2.45 • Interval -10.1 to 3.5
|
2.6 degree
Standard Error 2.41 • Interval -10.1 to 3.5
|
|
Change From Baseline in Passive Range of Motion (PROM) - Elbow Maximum Flexion
Follow up (between week 12 and week 20)
|
-1.9 degree
Standard Error 2.86 • Interval -10.8 to 5.1
|
1.0 degree
Standard Error 2.81 • Interval -10.8 to 5.1
|
SECONDARY outcome
Timeframe: week 4Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
The investigator's global assessment of response to treatment were determined with the use of the Global Response Scale using the following scores: -4 = very marked worsening; -3 = marked worsening; -2 = moderate worsening; -1 = mild worsening; 0 = no change; +1 = mild improvement; +2 = moderate improvement; +3 = marked improvement; +4 = very marked improvement.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=97 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Investigator's Global Assessment of Treatment Response (GATR) - Full Analysis Set
|
1.66 units on a scale
Standard Error 0.106
|
1.59 units on a scale
Standard Error 0.106
|
SECONDARY outcome
Timeframe: week 4Population: Full Analysis Set
The patient's global assessment of response to treatment were determined with the use of the Global Response Scale using the following scores: -4 = very marked worsening; -3 = marked worsening; -2 = moderate worsening; -1 = mild worsening; 0 = no change; +1 = mild improvement; +2 = moderate improvement; +3 = marked improvement; +4 = very marked improvement.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=97 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Patient's Global Assessment of Treatment Response (GATR) - Full Analysis Set
|
1.41 units on a scale
Standard Error 0.121
|
1.48 units on a scale
Standard Error 0.121
|
SECONDARY outcome
Timeframe: week 4Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=94 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Feeding
|
7 participants
|
5 participants
|
SECONDARY outcome
Timeframe: week 12Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=94 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Feeding
|
8 participants
|
6 participants
|
SECONDARY outcome
Timeframe: follow up visit, between week 12 and week 20Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=75 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=71 Participants
|
|---|---|---|
|
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Feeding
|
7 participants
|
5 participants
|
SECONDARY outcome
Timeframe: week 4Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=94 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Grooming
|
5 participants
|
6 participants
|
SECONDARY outcome
Timeframe: week 12Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=94 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Grooming
|
7 participants
|
10 participants
|
SECONDARY outcome
Timeframe: follow up visit, between week 12 and week 20Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=75 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=71 Participants
|
|---|---|---|
|
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Grooming
|
7 participants
|
6 participants
|
SECONDARY outcome
Timeframe: week 4Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=94 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Toilet Use
|
7 participants
|
6 participants
|
SECONDARY outcome
Timeframe: week 12Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=94 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Toilet Use
|
11 participants
|
7 participants
|
SECONDARY outcome
Timeframe: follow up visit, between week 12 and week 20Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=75 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=71 Participants
|
|---|---|---|
|
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Toilet Use
|
11 participants
|
5 participants
|
SECONDARY outcome
Timeframe: week 4Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=94 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Bathing/Showering
|
1 participants
|
7 participants
|
SECONDARY outcome
Timeframe: week 12Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=94 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Bathing/Showering
|
4 participants
|
6 participants
|
SECONDARY outcome
Timeframe: follow up visit, between week 12 and week 20Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=75 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=71 Participants
|
|---|---|---|
|
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Bathing/Showering
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: week 4Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=94 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Dressing
|
9 participants
|
6 participants
|
SECONDARY outcome
Timeframe: week 12Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=94 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=95 Participants
|
|---|---|---|
|
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Dressing
|
10 participants
|
8 participants
|
SECONDARY outcome
Timeframe: follow up visit, between week 12 and week 20Population: Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=75 Participants
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=71 Participants
|
|---|---|---|
|
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Dressing
|
8 participants
|
7 participants
|
Adverse Events
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
Serious adverse events
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=96 participants at risk
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=96 participants at risk
|
|---|---|---|
|
Infections and infestations
Acarodermatitis
|
1.0%
1/96 • Number of events 1 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
1.0%
1/96 • Number of events 1 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
1.0%
1/96 • Number of events 1 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
1.0%
1/96 • Number of events 1 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Nervous system disorders
Convulsion
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
1.0%
1/96 • Number of events 1 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.0%
1/96 • Number of events 1 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Nervous system disorders
Epilepsy
|
2.1%
2/96 • Number of events 2 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Nervous system disorders
Epileptic Aura
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
1.0%
1/96 • Number of events 2 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Gastrointestinal disorders
Fecaloma
|
1.0%
1/96 • Number of events 1 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
1.0%
1/96 • Number of events 1 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Infections and infestations
Implant site infection
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
1.0%
1/96 • Number of events 1 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Nervous system disorders
Loss of consciousness
|
1.0%
1/96 • Number of events 1 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
2.1%
2/96 • Number of events 2 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Eye disorders
Visual disturbance
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
1.0%
1/96 • Number of events 1 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
Other adverse events
| Measure |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
n=96 participants at risk
|
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
n=96 participants at risk
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
2.1%
2/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
2/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
2/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
1.0%
1/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Nervous system disorders
Epilepsy
|
3.1%
3/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
1.0%
1/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
2.1%
2/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Nervous system disorders
Headache
|
2.1%
2/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Vascular disorders
Haematoma
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
2.1%
2/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
General disorders
Injection site haematoma
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
4.2%
4/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
General disorders
Injection site pain
|
2.1%
2/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
2.1%
2/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.1%
3/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
4.2%
4/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
General disorders
Pain
|
0.00%
0/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
2.1%
2/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
1/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
2.1%
2/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
2.1%
2/96 • All SAEs/AEs up to 20 weeks after injection
The investigator asked the patient for AEs systematically at each visit. The table of "Other Adverse Events" includes all non-serious AEs. The Safety Analysis Set differs from the Full Analysis Set due to a randomization error (one patient randomized to low dilution in fact received high dilution).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No results to be published without written agreement by sponsor; manuscripts to be sent to sponsor at least 6 weeks before submission. Sponsor to give written opinion within 30 days. Sponsor is entitled to exert influence on the contents of publications, to postpone publications up to 36 months after end of the study, and to name co-authors. In case of justified doubts of 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