Trial Outcomes & Findings for IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb (NCT NCT00432666)

Results Overview

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

148 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2010-12-15

Participant Flow

Participant milestones

Participant milestones
Measure	incobotulinumtoxinA (Xeomin) incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Main Period STARTED	73	75
Main Period COMPLETED	71	74
Main Period NOT COMPLETED	2	1
Open-Label Extension Period STARTED	145	0
Open-Label Extension Period COMPLETED	120	0
Open-Label Extension Period NOT COMPLETED	25	0

Reasons for withdrawal

Reasons for withdrawal
Measure	incobotulinumtoxinA (Xeomin) incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Main Period Adverse Event	1	1
Main Period Consent Withdrawn	1	0
Open-Label Extension Period Withdrawal Criteria Occurred	1	0
Open-Label Extension Period Lack of Efficacy	6	0
Open-Label Extension Period Adverse Event	5	0
Open-Label Extension Period Consent withdrawn	10	0
Open-Label Extension Period Physician Decision	3	0

Baseline Characteristics

IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection	Total n=148 Participants Total of all reporting groups
Age Continuous	58.1 years STANDARD_DEVIATION 10.2 • n=5 Participants	53.3 years STANDARD_DEVIATION 13.3 • n=7 Participants	55.6 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	50 Participants n=7 Participants	95 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were not imputed

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors	50 Participants	28 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Responders at Week 4 Based on a Responder Definition of at Least 2 Points Improvement From Baseline in the Ashworth Score for Wrist Flexors	14 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=73 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits Week 2	45 Participants	22 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits Week 8	49 Participants	22 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits Week 12	31 Participants	18 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits Final Visit	29 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=54 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=55 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits Week 2	32 Participants	15 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits Week 4	34 Participants	21 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits Week 8	27 Participants	22 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits Week 12	23 Participants	16 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits Final Visit	21 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=35 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=38 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits Week 2	16 Participants	10 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits Week 4	19 Participants	12 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits Week 8	18 Participants	11 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits Week 12	12 Participants	11 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits Final Visit	10 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits Final Visit	28 Participants	17 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits Week 2	50 Participants	22 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits Week 4	50 Participants	27 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits Week 8	44 Participants	27 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits Week 12	35 Participants	23 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=26 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=31 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits Week 2	16 Participants	8 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits Week 4	17 Participants	11 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits Week 8	14 Participants	14 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits Week 12	14 Participants	10 Participants
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits Final Visit	11 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=54 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=55 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors Change of "-2" points	5 Participants	0 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors Change of "-1" points	27 Participants	15 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors Change of "0" points	22 Participants	39 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors Change of "+1" points	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=54 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=55 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors Change of "-2" points	5 Participants	1 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors Change of "-1" points	29 Participants	20 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors Change of "0" points	20 Participants	32 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors Change of "+1" points	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=54 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=55 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors Change of "-3" points	1 Participants	0 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors Change of "-2" points	6 Participants	2 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors Change of "-1" points	20 Participants	20 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors Change of "0" points	26 Participants	31 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors Change of "+1" points	0 Participants	2 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors Missing	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=54 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=55 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors Change of "-2" points	5 Participants	0 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors Change of "-1" points	18 Participants	16 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors Change of "0" points	31 Participants	36 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors Change of "+1" points	0 Participants	2 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=54 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=55 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors Change of "-2" points	2 Participants	0 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors Change of "-1" points	19 Participants	14 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors Change of "0" points	32 Participants	37 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors Change of "+1" points	1 Participants	3 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=35 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=38 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators Change of "-2" points	3 Participants	0 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators Change of "-1" points	13 Participants	10 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators Change of "0" points	18 Participants	27 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators Change of "+1" points	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=35 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=38 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators Change of "-3" points	1 Participants	0 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators Change of "-2" points	2 Participants	0 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators Change of "-1" points	16 Participants	12 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators Change of "0" points	16 Participants	24 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators Change of "+1" points	0 Participants	1 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=35 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=38 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators Change of "-3" points	1 Participants	0 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators Change of "-2" points	2 Participants	0 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators Change of "-1" points	15 Participants	11 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators Change of "0" points	16 Participants	25 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators Change of "+1" points	1 Participants	1 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=35 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=38 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators Missing	1 Participants	2 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators Change of "-2" points	2 Participants	0 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators Change of "-1" points	10 Participants	11 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators Change of "0" points	21 Participants	20 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators Change of "+1" points	1 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=35 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=38 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators Change of "-2" points	1 Participants	1 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators Change of "-1" points	9 Participants	8 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators Change of "0" points	22 Participants	21 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators Change of "+1" points	2 Participants	6 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators Missing	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=73 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors Change of "-3" points	1 Participants	0 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors Change of "-2" points	11 Participants	2 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors Change of "-1" points	33 Participants	20 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors Change of "0" points	27 Participants	51 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors Change of "+1" points	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=73 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors Change of "0" points	22 Participants	41 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors Change of "-3" points	1 Participants	0 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors Change of "-2" points	13 Participants	3 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors Change of "-1" points	36 Participants	25 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors Change of "+1" points	1 Participants	3 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=73 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors Change of "-3" points	1 Participants	0 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors Change of "-2" points	13 Participants	4 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors Change of "-1" points	35 Participants	18 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors Change of "0" points	21 Participants	47 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors Change of "+1" points	2 Participants	3 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors Missing	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=73 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors Change of "-3" points	1 Participants	0 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors Change of "-2" points	9 Participants	2 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors Change of "-1" points	21 Participants	16 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors Change of "0" points	38 Participants	47 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors Change of "+1" points	2 Participants	6 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors Missing	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=73 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors Change of "-2" points	2 Participants	0 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors Change of "-1" points	27 Participants	14 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors Change of "0" points	39 Participants	50 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors Change of "+1" points	4 Participants	7 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors Missing	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors Change of "+1" points	2 Participants	3 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors Change of "-3" points	4 Participants	0 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors Change of "-2" points	8 Participants	2 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors Change of "-1" points	38 Participants	20 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors Change of "0" points	21 Participants	50 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors Change of "-3" points	5 Participants	0 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors Change of "-2" points	15 Participants	5 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors Change of "-1" points	30 Participants	22 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors Change of "0" points	22 Participants	44 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors Change of "+1" points	1 Participants	3 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors Change of "-3" points	2 Participants	0 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors Change of "-2" points	18 Participants	3 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors Change of "-1" points	24 Participants	24 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors Change of "0" points	27 Participants	43 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors Change of "+1" points	1 Participants	4 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors Missing	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors Change of "-3" points	2 Participants	0 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors Change of "-2" points	9 Participants	2 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors Change of "-1" points	24 Participants	21 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors Change of "0" points	33 Participants	45 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors Change of "+1" points	3 Participants	5 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors Missing	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors Change of "-2" points	2 Participants	1 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors Change of "-1" points	26 Participants	16 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors Change of "0" points	39 Participants	51 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors Change of "+1" points	5 Participants	5 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors Missing	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=26 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=31 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors Change of "-2" points	3 Participants	1 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors Change of "-1" points	13 Participants	7 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors Change of "0" points	10 Participants	22 Participants
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors Change of "+1" points	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=26 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=31 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors Change of "-2" points	6 Participants	2 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors Change of "-1" points	11 Participants	9 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors Change of "0" points	9 Participants	18 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors Change of "+1" points	0 Participants	1 Participants
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=26 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=31 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors Change of "-2" points	6 Participants	2 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors Change of "-1" points	8 Participants	12 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors Change of "0" points	11 Participants	15 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors Change of "+1" points	1 Participants	0 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors Change of "+2" points	0 Participants	1 Participants
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=26 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=31 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors Change of "-3" points	0 Participants	1 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors Change of "-2" points	4 Participants	1 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors Change of "-1" points	10 Participants	8 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors Change of "0" points	11 Participants	14 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors Change of "+1" points	0 Participants	4 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors Change of "+2" points	0 Participants	1 Participants
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors Missing	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects

The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=26 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=31 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors Change of "-3" points	0 Participants	1 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors Change of "-2" points	2 Participants	0 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors Change of "-1" points	9 Participants	9 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors Change of "0" points	13 Participants	14 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors Change of "+1" points	1 Participants	4 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors Change of "+2" points	0 Participants	1 Participants
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors Missing	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Period starting at Visit 2 (baseline injection) of the Main Period up to onset of treatment effect

Population: Results for placebo patients were not displayed because the upper limit of the confidence interval was not estimable (this can not be entered because a numeric entry is expected). The results of this analysis are therefore given as "Onset of Treatment Effect \[classified\]" under "Other Pre-specified Outcome".

Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if "yes": when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was "yes" or until the final visit of the Main Period was performed. For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Time to Onset of Treatment Effect	4.0 Days Interval 3.0 to 7.0	—

SECONDARY outcome

Timeframe: Defined as time (weeks) from Visit 2 (injection session at Baseline, Day 0) to the subjective estimation of the waning of the effect

Subject who reported an onset of treatment effect were asked at each visit/telephone contact starting at week 4 at earliest if he/she felt that there was a waning of the treatment effect. The same question was asked at each of the following telephone contacts and visits (up to the Final Visit of the Main Period) if the answer at the respective previous visit was "no". If the patient answered with "yes" he/she will be asked at which week after the injection (= the time span in weeks) the waning of effect occurred. For all subjects without an onset of treatment effect the waning was set to zero.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Time to Waning of Treatment Effect	10.0 Weeks Interval 9.0 to 11.0	10.0 Weeks Interval 10.0 to 11.0

SECONDARY outcome

Timeframe: Period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator

The duration of treatment effect is defined as the time period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator. For subjects without any treatment effect the duration of effect was set to zero.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Duration of Treatment Effect	87.0 Days Interval 86.0 to 94.0	84.0 Days Interval 0.0 to 84.0

SECONDARY outcome

Timeframe: Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects

The Investigator's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Investigator's Global Assessment of Efficacy Very good	11 Participants	2 Participants
Investigator's Global Assessment of Efficacy Good	32 Participants	24 Participants
Investigator's Global Assessment of Efficacy Moderate	14 Participants	12 Participants
Investigator's Global Assessment of Efficacy Poor	15 Participants	35 Participants
Investigator's Global Assessment of Efficacy Missing	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects

The Patient's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Patient's Global Assessment of Efficacy Very good	7 Participants	2 Participants
Patient's Global Assessment of Efficacy Good	41 Participants	21 Participants
Patient's Global Assessment of Efficacy Moderate	9 Participants	17 Participants
Patient's Global Assessment of Efficacy Poor	15 Participants	33 Participants
Patient's Global Assessment of Efficacy Missing	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects

The Carer's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Carer's Global Assessment of Efficacy Very good	8 Participants	2 Participants
Carer's Global Assessment of Efficacy Good	21 Participants	17 Participants
Carer's Global Assessment of Efficacy Moderate	9 Participants	10 Participants
Carer's Global Assessment of Efficacy Poor	8 Participants	24 Participants
Carer's Global Assessment of Efficacy No carer	26 Participants	19 Participants
Carer's Global Assessment of Efficacy Missing	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "-3" points	1 Participants	0 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "-2" points	7 Participants	1 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "-1" points	21 Participants	8 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "0" points	43 Participants	66 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "+1" points	2 Participants	0 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "+2" points	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "-2" points	12 Participants	1 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "-1" points	21 Participants	15 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "0" points	40 Participants	57 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "+1" points	1 Participants	1 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "+2" points	0 Participants	0 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "-3" points	1 Participants	0 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "-2" points	6 Participants	1 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "-1" points	26 Participants	15 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "0" points	37 Participants	57 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "+1" points	2 Participants	1 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "+2" points	0 Participants	0 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target Missing	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "-3" points	1 Participants	0 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "-2" points	3 Participants	2 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "-1" points	24 Participants	10 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "0" points	42 Participants	58 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "+1" points	2 Participants	3 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target Change of "+2" points	0 Participants	0 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target Missing	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target Change of "-2" points	2 Participants	1 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target Change of "-1" points	20 Participants	14 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target Change of "0" points	47 Participants	55 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target Change of "+1" points	2 Participants	3 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target Change of "+2" points	1 Participants	0 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target Missing	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Hygiene" Change of "-3" points	2 Participants	0 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Hygiene" Change of "-2" points	6 Participants	1 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Hygiene" Change of "-1" points	12 Participants	7 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Hygiene" Change of "0" points	52 Participants	66 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Hygiene" Change of "+1" points	1 Participants	1 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Hygiene" Change of "+2" points	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Hygiene" Change of "-3" points	3 Participants	0 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Hygiene" Change of "-2" points	5 Participants	1 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Hygiene" Change of "-1" points	14 Participants	11 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Hygiene" Change of "0" points	48 Participants	59 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Hygiene" Change of "+1" points	3 Participants	3 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Hygiene" Change of "+2" points	0 Participants	0 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Hygiene" Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Hygiene" Change of "-3" points	2 Participants	0 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Hygiene" Change of "-2" points	6 Participants	1 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Hygiene" Change of "-1" points	16 Participants	12 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Hygiene" Change of "0" points	44 Participants	58 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Hygiene" Change of "+1" points	3 Participants	3 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Hygiene" Change of "+2" points	0 Participants	0 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Hygiene" Missing	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Hygiene" Change of "-3" points	1 Participants	0 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Hygiene" Change of "-2" points	4 Participants	1 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Hygiene" Change of "-1" points	11 Participants	12 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Hygiene" Change of "0" points	50 Participants	53 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Hygiene" Change of "+1" points	4 Participants	7 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Hygiene" Change of "+2" points	1 Participants	0 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Hygiene" Missing	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Hygiene" Change of "-3" points	1 Participants	1 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Hygiene" Change of "-2" points	2 Participants	1 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Hygiene" Change of "-1" points	10 Participants	9 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Hygiene" Change of "0" points	50 Participants	53 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Hygiene" Change of "+1" points	6 Participants	9 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Hygiene" Change of "+2" points	2 Participants	0 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Hygiene" Missing	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Dressing" Change of "-3" points	1 Participants	0 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Dressing" Change of "-2" points	3 Participants	0 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Dressing" Change of "-1" points	16 Participants	5 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Dressing" Change of "0" points	51 Participants	69 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Dressing" Change of "+1" points	2 Participants	1 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Dressing" Change of "+2" points	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Dressing" Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Dressing" Change of "-2" points	5 Participants	2 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Dressing" Change of "-1" points	12 Participants	15 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Dressing" Change of "0" points	53 Participants	54 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Dressing" Change of "+1" points	3 Participants	3 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Dressing" Change of "+2" points	0 Participants	0 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Dressing" Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Dressing" Change of "-3" points	1 Participants	0 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Dressing" Change of "-2" points	3 Participants	2 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Dressing" Change of "-1" points	16 Participants	13 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Dressing" Change of "0" points	48 Participants	56 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Dressing" Change of "+1" points	3 Participants	3 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Dressing" Change of "+2" points	0 Participants	0 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Dressing" Missing	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Dressing" Change of "+2" points	0 Participants	0 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Dressing" Missing	2 Participants	2 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Dressing" Change of "-3" points	1 Participants	0 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Dressing" Change of "-2" points	3 Participants	3 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Dressing" Change of "-1" points	16 Participants	13 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Dressing" Change of "0" points	47 Participants	53 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Dressing" Change of "+1" points	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Dressing" Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Dressing" Change of "-2" points	2 Participants	2 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Dressing" Change of "-1" points	14 Participants	16 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Dressing" Change of "0" points	50 Participants	51 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Dressing" Change of "+1" points	5 Participants	4 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Dressing" Change of "+2" points	0 Participants	0 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Dressing" Missing	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Limb Position" Change of "-3" points	1 Participants	0 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Limb Position" Change of "-2" points	2 Participants	0 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Limb Position" Change of "-1" points	22 Participants	8 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Limb Position" Change of "0" points	43 Participants	65 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Limb Position" Change of "+1" points	5 Participants	2 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Limb Position" Change of "+2" points	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Limb Position" Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Limb Position" Change of "-2" points	7 Participants	1 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Limb Position" Change of "-1" points	25 Participants	10 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Limb Position" Change of "0" points	37 Participants	59 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Limb Position" Change of "+1" points	4 Participants	4 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Limb Position" Change of "+2" points	0 Participants	0 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Limb Position" Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Limb Position" Change of "-1" points	26 Participants	10 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Limb Position" Change of "0" points	37 Participants	61 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Limb Position" Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Limb Position" Change of "+1" points	4 Participants	2 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Limb Position" Change of "-2" points	4 Participants	1 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Limb Position" Change of "+2" points	0 Participants	0 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Limb Position" Missing	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Limb Position" Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Limb Position" Change of "-2" points	3 Participants	3 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Limb Position" Change of "-1" points	19 Participants	9 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Limb Position" Change of "0" points	45 Participants	56 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Limb Position" Change of "+1" points	3 Participants	5 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Limb Position" Change of "+2" points	1 Participants	0 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Limb Position" Missing	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Limb Position" Change of "-3" points	0 Participants	0 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Limb Position" Change of "-2" points	1 Participants	3 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Limb Position" Change of "-1" points	22 Participants	14 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Limb Position" Change of "0" points	42 Participants	51 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Limb Position" Change of "+1" points	5 Participants	5 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Limb Position" Change of "+2" points	1 Participants	0 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Limb Position" Missing	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Pain" Change of "-3" points	1 Participants	0 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Pain" Change of "-2" points	3 Participants	0 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Pain" Change of "-1" points	12 Participants	5 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Pain" Change of "0" points	54 Participants	69 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Pain" Change of "+1" points	3 Participants	0 Participants
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Pain" Change of "+2" points	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Pain" Change of "-3" points	2 Participants	0 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Pain" Change of "-2" points	8 Participants	2 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Pain" Change of "-1" points	11 Participants	4 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Pain" Change of "0" points	46 Participants	67 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Pain" Change of "+1" points	6 Participants	1 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Pain" Change of "+2" points	0 Participants	0 Participants
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Pain" Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Pain" Change of "-3" points	2 Participants	0 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Pain" Change of "-2" points	4 Participants	1 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Pain" Change of "-1" points	11 Participants	7 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Pain" Change of "0" points	49 Participants	65 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Pain" Change of "+1" points	5 Participants	0 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Pain" Change of "+2" points	0 Participants	1 Participants
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Pain" Missing	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Pain" Change of "-3" points	3 Participants	0 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Pain" Change of "-2" points	3 Participants	1 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Pain" Change of "-1" points	10 Participants	9 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Pain" Change of "0" points	52 Participants	62 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Pain" Change of "+1" points	3 Participants	0 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Pain" Change of "+2" points	0 Participants	1 Participants
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Pain" Missing	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects

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

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Pain" Change of "-3" points	2 Participants	0 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Pain" Change of "-2" points	3 Participants	2 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Pain" Change of "-1" points	11 Participants	7 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Pain" Change of "0" points	51 Participants	63 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Pain" Change of "+1" points	4 Participants	0 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Pain" Change of "+2" points	0 Participants	1 Participants
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Pain" Missing	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change

The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" No carer	26 Participants	20 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" No longer necessary	3 Participants	0 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" Less difficult	15 Participants	9 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" Unchanged	24 Participants	38 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" More difficult	5 Participants	4 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" Required for the first time	0 Participants	3 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change

The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" No carer	26 Participants	22 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" No longer necessary	2 Participants	1 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" Less difficult	12 Participants	4 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" Unchanged	26 Participants	38 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" More difficult	7 Participants	5 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" Required for the first time	0 Participants	3 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" Missing	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change

The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" No carer	27 Participants	22 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" No longer necessary	2 Participants	0 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" Less difficult	8 Participants	4 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" Unchanged	26 Participants	36 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" More difficult	9 Participants	5 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" Required for the first time	1 Participants	6 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" Missing	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change

The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" Missing	0 Participants	1 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" No carer	26 Participants	20 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" No longer necessary	0 Participants	0 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" Less difficult	17 Participants	12 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" Unchanged	19 Participants	36 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" More difficult	11 Participants	5 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" Required for the first time	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change

The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" No carer	26 Participants	22 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" No longer necessary	1 Participants	0 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" Less difficult	12 Participants	15 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" Unchanged	21 Participants	26 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" More difficult	13 Participants	9 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" Required for the first time	0 Participants	1 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" Missing	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change

The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" No carer	27 Participants	22 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" No longer necessary	1 Participants	1 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" Less difficult	12 Participants	12 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" Unchanged	21 Participants	26 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" More difficult	12 Participants	10 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" Required for the first time	0 Participants	2 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" Missing	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change

The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" No carer	26 Participants	20 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" No longer necessary	3 Participants	0 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" Less difficult	11 Participants	8 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" Unchanged	27 Participants	38 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" More difficult	4 Participants	6 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" Required for the first time	2 Participants	2 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change

The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" No carer	26 Participants	22 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" No longer necessary	1 Participants	2 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" Less difficult	12 Participants	7 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" Unchanged	25 Participants	33 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" More difficult	6 Participants	8 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" Required for the first time	3 Participants	1 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" Missing	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change

The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" No carer	27 Participants	22 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" No longer necessary	1 Participants	2 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" Less difficult	12 Participants	6 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" Unchanged	23 Participants	32 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" More difficult	6 Participants	9 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" Required for the first time	4 Participants	2 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" Missing	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change

The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" No carer	26 Participants	20 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" No longer necessary	2 Participants	1 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" Less difficult	18 Participants	11 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" Unchanged	25 Participants	36 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" More difficult	2 Participants	4 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" Required for the first time	0 Participants	2 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change

The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" No carer	26 Participants	22 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" No longer necessary	2 Participants	3 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" Less difficult	17 Participants	13 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" Unchanged	24 Participants	28 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" More difficult	4 Participants	6 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" Required for the first time	0 Participants	1 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" Missing	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change

The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" No carer	27 Participants	22 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" No longer necessary	3 Participants	4 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" Less difficult	16 Participants	10 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" Unchanged	24 Participants	29 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" More difficult	3 Participants	6 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" Required for the first time	0 Participants	2 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" Missing	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change

The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" No carer	26 Participants	20 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" No longer necessary	1 Participants	1 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" Less difficult	5 Participants	1 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" Unchanged	40 Participants	51 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" More difficult	1 Participants	0 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" Required for the first time	0 Participants	1 Participants
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" Missing	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change

The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" No longer necessary	2 Participants	1 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" Required for the first time	0 Participants	2 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" No carer	26 Participants	22 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" Less difficult	2 Participants	2 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" Unchanged	42 Participants	46 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" More difficult	1 Participants	0 Participants
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" Missing	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change

The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" Less difficult	1 Participants	2 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" No carer	27 Participants	22 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" No longer necessary	3 Participants	1 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" Unchanged	41 Participants	45 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" More difficult	1 Participants	1 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" Required for the first time	0 Participants	2 Participants
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" Missing	0 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Period starting at baseline injection of the Main Period up to onset of treatment effect

Population: These results are a different presentation of the results of the secondary outcome measure "Time to Onset of Treatment Effect". For subjects without any treatment effect the time to onset of effect was censored at the last visit.

Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if "yes": when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was "yes" or until the final visit of the Main Period was performed. For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period.

Outcome measures

Outcome measures
Measure	incobotulinumtoxinA (Xeomin) n=73 Participants incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 Participants Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Onset of Treatment Effect [Classified] Onset at Day 1, 2 or 3	32 Participants	14 Participants
Onset of Treatment Effect [Classified] Onset at Day 4, 5 or 6	12 Participants	4 Participants
Onset of Treatment Effect [Classified] Onset at Day 7, 8 or 9	9 Participants	11 Participants
Onset of Treatment Effect [Classified] Onset at Day 10, 11 or 12	1 Participants	6 Participants
Onset of Treatment Effect [Classified] Onset at Day 13, 14 or 15	3 Participants	1 Participants
Onset of Treatment Effect [Classified] Onset at Day 16, 17 or 18	1 Participants	1 Participants
Onset of Treatment Effect [Classified] Onset at Day 19, 20 or 21	3 Participants	3 Participants
Onset of Treatment Effect [Classified] Onset at Day 22, 23 or 24	0 Participants	2 Participants
Onset of Treatment Effect [Classified] Onset later than Day 25	2 Participants	1 Participants
Onset of Treatment Effect [Classified] Censored	10 Participants	32 Participants

Adverse Events

incobotulinumtoxinA (Xeomin)

Serious events: 4 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	incobotulinumtoxinA (Xeomin) n=73 participants at risk incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 participants at risk Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	1.4% 1/73 • Number of events 1 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.	0.00% 0/75 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.
Infections and infestations Cellulitis	1.4% 1/73 • Number of events 1 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.	0.00% 0/75 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.
Nervous system disorders Epilepsy	1.4% 1/73 • Number of events 1 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.	0.00% 0/75 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.
Vascular disorders Hypertension	1.4% 1/73 • Number of events 1 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.	0.00% 0/75 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.
Nervous system disorders Intracranial haematoma	0.00% 0/73 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.	1.3% 1/75 • Number of events 1 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.
Nervous system disorders Paraparesis	1.4% 1/73 • Number of events 1 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.	0.00% 0/75 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.
Nervous system disorders Status epilepticus	1.4% 1/73 • Number of events 1 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.	0.00% 0/75 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.
Ear and labyrinth disorders Vertigo	1.4% 1/73 • Number of events 1 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.	0.00% 0/75 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.

Other adverse events

Other adverse events
Measure	incobotulinumtoxinA (Xeomin) n=73 participants at risk incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection	Placebo n=75 participants at risk Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Injury, poisoning and procedural complications Contusion	1.4% 1/73 • Number of events 1 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.	2.7% 2/75 • Number of events 3 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.
Gastrointestinal disorders Diarrhoea	2.7% 2/73 • Number of events 2 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.	2.7% 2/75 • Number of events 2 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.
Nervous system disorders Epilepsy	2.7% 2/73 • Number of events 2 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.	0.00% 0/75 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.
Nervous system disorders Headache	2.7% 2/73 • Number of events 4 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.	1.3% 1/75 • Number of events 1 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.
Metabolism and nutrition disorders Hypercholesterolaemia	2.7% 2/73 • Number of events 2 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.	1.3% 1/75 • Number of events 1 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.
Metabolism and nutrition disorders Hyperglycaemia	4.1% 3/73 • Number of events 3 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.	0.00% 0/75 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.
Gastrointestinal disorders Vomiting	0.00% 0/73 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.	2.7% 2/75 • Number of events 2 • All SAEs/AEs during Double-Blind Period After Injection. The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.

Additional Information

Angelika Hanschmann

Merz Pharmaceuticals GmbH

Phone: ++49-69-1503

Email: [email protected]

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 wks before submission. Sponsor to give written opinion within 30 d. 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