Spasticity of the Upper and Lower Limb Due to Cerebral Causes
Conditions
Brief summary
The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.
Detailed description
A dose-titration approach will be used over three injection cycles, with a flexible observation period after injections of 12-16 weeks and a total duration of up to 48 weeks. Cycle 1 and 2: upper and/or lower limb to be treated; Cycle 3: upper and lower limb to be treated.
Interventions
Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units. For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: intramuscular injection.
Sponsors
Merz Pharmaceuticals GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Upper and lower limb spasticity of the same body side due to cerebral causes * Time since event leading to spasticity in the target body side greater than 12 weeks * Need for 800 units Botulinum toxin type A
Exclusion criteria
* Body weight below 50kg * Fixed contractures of the target joint * Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A * Infection at the injection site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | From baseline to week 36-48 | Treatment-emergent Adverse Events (TEASs) are events observed from the time point of first injection until 16 weeks after last injection. Values reported here refer to the number of subjects affected. |
| Investigator's Global Assessment of Tolerability in Subjects | Up to Week 48 | A 4-point Likert scale was used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Control Visits of Injection Cycles | From Study Baseline to Week 4, 16-20 and 28-36 | The AS 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). |
| Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | From Study Baseline to Week 12-16, 24-32 and 36-48 | The AS 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). |
| Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | From Cycle Baseline to Week 4 of Each Cycle | Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS 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). |
| Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | From Cycle Baseline to Week 4 of Each Cycle | Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS 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). |
| Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | From Study Baseline to Week 4, 16-20 and 28-36 | Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS 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). |
| Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | From Study Baseline to Week 12-16, 24-32 and 36-48 | Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS 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). |
| Resistance to Passive Movement Scale (REPAS) Scores of Treated Side | From Cycle Baseline to Week 4 of Each Cycle | The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52. |
| Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Injection Cycle Baseline Visits to Respective Control Visits | From Cycle Baseline to Week 4 of Each Cycle | The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52. |
| Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Control Visits of Injection Cycles | From Study Baseline to Week 4, 16-20 and 28-36 | The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52. |
| Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | From Study Baseline to Week 12-16, 24-32 and 36-48 | The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52. |
| Functional Ambulation Classification (FAC) Scale Scores | From Cycle Baseline to Week 4 of Each Cycle | The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent. |
| Change of Functional Ambulation Classification (FAC) Score From Injection Cycle Baseline Visits to Respective Control Visits | From Cycle Baseline to Week 4 of Each Cycle | The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent. |
| Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Control Visits of Injection Cycles | From Study Baseline to Week 4, 16-20 and 28-36 | The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent. |
| Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | From Study Baseline to Week 12-16, 24-32 and 36-48 | The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent. |
| Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit | From Cycle Baseline to Week 4 of Each Cycle | The AS 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). |
| Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb | From Cycle Baseline to Week 4 of Each Cycle | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value. |
| Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Injection Cycle Baseline Visits to Respective Control Visits | Week 4 of Each Cycle | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change. |
| Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Control Visits of Injection Cycles | From Study Baseline to Week 4, 16-20 and 28-36 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change. |
| Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit. | From Study Baseline to Week 12-16, 24-32 and 36-48 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change. |
| Global Assessment of Efficacy Scores | Week 12-16, 24-32 and 36-48 | Investigator assessment. The global assessment of efficacy will be assessed by the investigator, the subject, and the caregiver using a 4-point Likert scale with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. |
| EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | From Cycle Baseline to Week 4 of Each Cycle | The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems. |
| Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | From Cycle Baseline to Week 4 of Each Cycle | The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome). |
| Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | From Cycle Baseline to Week 4 of Each Cycle | The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories. |
| Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | From Cycle Baseline to Week 4 of Each Cycle | The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome). |
| Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | From Study Baseline to Week 4, 16-20 and 28-36 | The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories. |
| Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | From Study Baseline to Week 4, 16-20 and 28-36 | The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement |
| Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | From Study Baseline to Week 12-16, 24-32 and 36-48 | The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories. |
| Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | From Study Baseline to Week 12-16, 24-32 and 36-48 | The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement. |
| Goal Attainment Scale (GAS) Scores for Upper and Lower Limb, Respectively | From Cycle Baseline Visit to Week 12-16, 24-32 and 36-48 | Change in goal attainment T-scores from respective injection cycle baseline visit. GAS measures the extent to which subject's individual goals are achieved in course of intervention. Subject and treating team have to identify 2 personal goals for each treated limb at each injection cycle. Investigator rates the GAS score for each injection cycle. Degree of goal attainment is rated on 5-point scale (-2, -1, 0, +1, +2; study baseline set to -1) and in order to account for interindividual differences in the number of goals, ratings are computed with the Kiresuk formula (Kiresuk & Sherman, Community Mental Health Journal. 1968;4(6):443-53) resulting in T-scores measuring the degree of goal attainment at each visit. A score of 50 indicates that the individual has reached the expected level of achievement for all goals. The size of change from measurement to measurement indicates incremental change towards or away from goal attainment. Positive values indicate a higher goal attainment. |
| Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Injection Cycle Baseline Visits to Respective Control Visits | From Cycle Baseline to Week 4 of Each Cycle | The AS 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). |
Countries
Canada, France, Germany, Italy, Norway, Portugal, Spain, United States
Participant flow
Recruitment details
The clinical study was conducted at 30 sites located in Canada, France, Germany, Italy, Norway, Portugal, Spain, and the United States of America.
Participants by arm
| Arm | Count |
|---|---|
| IncobotulinumtoxinA (Xeomin) (up to 800 Units) IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.
For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection. | 155 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative reason | 1 |
| Overall Study | Adverse Event | 5 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Non-compliance | 1 |
| Overall Study | Predefined discontinuation criteria | 3 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | IncobotulinumtoxinA (Xeomin) (up to 800 Units) |
|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 13.1 |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 34 / 155 |
| serious Total, serious adverse events | 17 / 155 |
Outcome results
Primary
Investigator's Global Assessment of Tolerability in Subjects
A 4-point Likert scale was used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.
Time frame: Up to Week 48
Population: Safety evaluation set (SES) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Investigator's Global Assessment of Tolerability in Subjects | Poor | 0 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Investigator's Global Assessment of Tolerability in Subjects | Very good | 121 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Investigator's Global Assessment of Tolerability in Subjects | Good | 29 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Investigator's Global Assessment of Tolerability in Subjects | Moderate | 3 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Investigator's Global Assessment of Tolerability in Subjects | Missing | 2 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Investigator's Global Assessment of Tolerability in Subjects | Good | 26 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Investigator's Global Assessment of Tolerability in Subjects | Missing | 10 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Investigator's Global Assessment of Tolerability in Subjects | Moderate | 3 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Investigator's Global Assessment of Tolerability in Subjects | Poor | 2 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Investigator's Global Assessment of Tolerability in Subjects | Very good | 111 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Investigator's Global Assessment of Tolerability in Subjects | Very good | 117 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Investigator's Global Assessment of Tolerability in Subjects | Good | 20 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Investigator's Global Assessment of Tolerability in Subjects | Poor | 0 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Investigator's Global Assessment of Tolerability in Subjects | Missing | 2 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Investigator's Global Assessment of Tolerability in Subjects | Moderate | 1 subjects |
Primary
Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication
Treatment-emergent Adverse Events (TEASs) are events observed from the time point of first injection until 16 weeks after last injection. Values reported here refer to the number of subjects affected.
Time frame: From baseline to week 36-48
Population: Safety evaluation set (SES) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any TEAE | 56 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any related TEAE | 7 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any TEAE of special interest | 6 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any related TEAE of special interest | 2 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any serious TEAE | 4 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any related serious TEAE | 0 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any related serious TEAE | 0 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any TEAE | 57 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any related TEAE of special interest | 4 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any serious TEAE | 11 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any related TEAE | 8 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any TEAE of special interest | 8 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any related TEAE | 4 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any TEAE of special interest | 7 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any related serious TEAE | 0 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any related TEAE of special interest | 3 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any TEAE | 36 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication | Any serious TEAE | 3 subjects |
Secondary
Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity
Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Population: Full analysis set (FAS) - only subjects treated in the respective pattern in the respective injection cycle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Thumb in palm | 2.4 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended knee | 2.6 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed elbow | 2.6 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pes equinovalgus | 2.8 units on a scale | Standard Deviation 0.4 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Internally rotated hip | 3.0 units on a scale | — |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended elbow | 2.7 units on a scale | Standard Deviation 0.5 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended hallux | 1.7 units on a scale | Standard Deviation 1.1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed toes | 1.8 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed knee | 2.4 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Clenched fist | 2.9 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Adducted thigh | 1.8 units on a scale | Standard Deviation 0.5 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pes equinovarus | 2.8 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Internally rotated/extended/adducted shoulder | 2.7 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed wrist | 2.7 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pronated forearm | 2.7 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended hallux | 0.9 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed knee | 2.0 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended knee | 2.3 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pes equinovarus | 2.1 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Internally rotated/extended/adducted shoulder | 2.2 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed toes | 1.3 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed elbow | 1.9 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Thumb in palm | 1.5 units on a scale | Standard Deviation 1.1 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended elbow | 1.8 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pronated forearm | 1.6 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Internally rotated hip | 2.0 units on a scale | — |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed wrist | 1.8 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Clenched fist | 2.0 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pes equinovalgus | 2.4 units on a scale | Standard Deviation 1.3 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Adducted thigh | 1.5 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pronated forearm | 2.4 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Thumb in palm | 2.3 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended hallux | 1.8 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed toes | 1.6 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended knee | 2.1 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pes equinovarus | 2.6 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Internally rotated hip | 2.0 units on a scale | Standard Deviation 1.4 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Internally rotated/extended/adducted shoulder | 2.5 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed knee | 2.4 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Clenched fist | 2.7 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended elbow | 2.5 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pes equinovalgus | 2.6 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed elbow | 2.4 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed wrist | 2.4 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Adducted thigh | 2.0 units on a scale | Standard Deviation 1.2 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Internally rotated/extended/adducted shoulder | 2.0 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pronated forearm | 1.7 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Adducted thigh | 1.9 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed wrist | 1.5 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed toes | 1.1 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pes equinovarus | 1.9 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Clenched fist | 1.8 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended knee | 1.8 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pes equinovalgus | 1.9 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Thumb in palm | 1.4 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed knee | 1.8 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed elbow | 1.7 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Internally rotated hip | 2.0 units on a scale | Standard Deviation 1.4 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended elbow | 2.1 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended hallux | 0.9 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended knee | 2.2 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Internally rotated/extended/adducted shoulder | 2.5 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed elbow | 2.4 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended elbow | 2.6 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pronated forearm | 2.5 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed wrist | 2.4 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Clenched fist | 2.5 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Thumb in palm | 2.2 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed hip | 1.8 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Adducted thigh | 2.3 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Internally rotated hip | 2.7 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed knee | 2.5 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pes equinovarus | 2.5 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pes equinovalgus | 2.3 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended hallux | 1.9 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed toes | 1.9 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Adducted thigh | 2.0 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed hip | 1.4 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Internally rotated hip | 1.7 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pes equinovalgus | 2.0 units on a scale | Standard Deviation 1.1 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Thumb in palm | 1.3 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Clenched fist | 1.5 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pronated forearm | 1.4 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended elbow | 1.7 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed toes | 1.1 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended hallux | 1.1 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed elbow | 1.4 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Internally rotated/extended/adducted shoulder | 1.9 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Extended knee | 1.5 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed wrist | 1.4 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Flexed knee | 1.8 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | Pes equinovarus | 1.6 units on a scale | Standard Deviation 0.9 |
Secondary
Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Population: The full analysis set (FAS) is the subset of all subjects who were exposed to study medication at least once. Only subjects treated in the target joint in the respective cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit | 3.0 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit | 2.1 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit | 2.7 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit | 2.0 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit | 2.6 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit | 1.7 units on a scale | Standard Deviation 1 |
Secondary
Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome).
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | 6.7 units on a scale | Standard Deviation 14.1 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | 2.4 units on a scale | Standard Deviation 12.4 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | 1.7 units on a scale | Standard Deviation 12.4 |
Secondary
Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement
Time frame: From Study Baseline to Week 4, 16-20 and 28-36
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | 6.7 units on a scale | Standard Deviation 14.1 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | 9.6 units on a scale | Standard Deviation 16.3 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | 8.6 units on a scale | Standard Deviation 17 |
Secondary
Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement.
Time frame: From Study Baseline to Week 12-16, 24-32 and 36-48
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | 7.1 units on a scale | Standard Deviation 16.3 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | 6.9 units on a scale | Standard Deviation 15.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | 10.5 units on a scale | Standard Deviation 17.5 |
Secondary
Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits
Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Population: Full analysis set (FAS) - only subjects treated in the respective pattern of respective injection cycle were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Flexed elbow | -0.7 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Flexed wrist | -0.9 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Aducted thigh | -0.3 units on a scale | Standard Deviation 0.5 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Internally rotated/extended/adducted shoulder | -0.5 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Extended elbow | -0.9 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Pronated forearm | -1.1 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Clenched fist | -0.9 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Thumb in palm | -0.9 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Internally rotated hip | -1.0 units on a scale | — |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Flexed knee | -0.4 units on a scale | Standard Deviation 0.5 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Extended knee | -0.4 units on a scale | Standard Deviation 0.5 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Pes equinovarus | -0.7 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Pes equinovalgus | -0.4 units on a scale | Standard Deviation 1.1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Extended hallux | -0.8 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Flexed toes | -0.5 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Extended hallux | -0.9 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Pronated forearm | -0.7 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Flexed wrist | -0.9 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Extended knee | -0.4 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Pes equinovalgus | -0.7 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Internally rotated hip | 0.0 units on a scale | Standard Deviation 0 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Aducted thigh | -0.1 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Thumb in palm | -0.9 units on a scale | Standard Deviation 1.1 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Internally rotated/extended/adducted shoulder | -0.6 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Flexed toes | -0.5 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Flexed knee | -0.6 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Flexed elbow | -0.7 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Pes equinovarus | -0.7 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Extended elbow | -0.5 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Clenched fist | -0.9 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Pes equinovarus | -0.8 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Extended elbow | -0.8 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Flexed wrist | -1.0 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Flexed toes | -0.8 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Clenched fist | -1.1 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Thumb in palm | -0.9 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Aducted thigh | -0.1 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Pes equinovalgus | -0.3 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Internally rotated hip | -1.0 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Flexed knee | -0.8 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Pronated forearm | -1.0 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Flexed hip | -0.4 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Extended knee | -0.7 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Extended hallux | -0.8 units on a scale | Standard Deviation 1.3 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Internally rotated/extended/adducted shoulder | -0.5 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | Flexed elbow | -0.9 units on a scale | Standard Deviation 0.9 |
Secondary
Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles
Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: From Study Baseline to Week 4, 16-20 and 28-36
Population: Full analysis set (FAS) - only subjects treated in the respective pattern of respective injection cycle were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Flexed elbow | -0.7 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Flexed knee | -0.4 units on a scale | Standard Deviation 0.5 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Clenched fist | -0.9 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Pes equinovalgus | -0.4 units on a scale | Standard Deviation 1.1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Internally rotated hip | -1.0 units on a scale | — |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Thumb in palm | -0.9 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Flexed toes | -0.5 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Adducted thigh | -0.3 units on a scale | Standard Deviation 0.5 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Extended elbow | -0.9 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Extended hallux | -0.8 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Pes equinovarus | -0.7 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Pronated forearm | -1.1 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Internally rotated/extended/adducted shoulder | -0.5 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Extended knee | -0.4 units on a scale | Standard Deviation 0.5 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Flexed wrist | -0.9 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Internally rotated/extended/adducted shoulder | -0.6 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Flexed toes | -0.5 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Flexed elbow | -0.9 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Extended elbow | -0.7 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Pronated forearm | -1.0 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Flexed wrist | -1.1 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Clenched fist | -1.1 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Thumb in palm | -1.0 units on a scale | Standard Deviation 1.2 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Adducted thigh | -0.1 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Internally rotated hip | -0.5 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Flexed knee | -0.4 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Extended knee | -0.4 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Pes equinovarus | -0.8 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Pes equinovalgus | -0.9 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Extended hallux | -0.9 units on a scale | Standard Deviation 1.1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Flexed wrist | -1.2 units on a scale | Standard Deviation 1.1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Pes equinovalgus | -0.4 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Flexed knee | -0.4 units on a scale | Standard Deviation 1.2 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Pronated forearm | -1.1 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Flexed elbow | -1.2 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Extended knee | -0.6 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Extended elbow | -0.9 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Flexed toes | -0.6 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Pes equinovarus | -1.1 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Flexed hip | -0.6 units on a scale | Standard Deviation 1.5 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Thumb in palm | -1.1 units on a scale | Standard Deviation 1.3 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Internally rotated/extended/adducted shoulder | -0.5 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Adducted thigh | -0.6 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Clenched fist | -1.4 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Extended hallux | -0.2 units on a scale | Standard Deviation 1.3 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | Internally rotated hip | -0.7 units on a scale | Standard Deviation 1.5 |
Secondary
Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit
Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: From Study Baseline to Week 12-16, 24-32 and 36-48
Population: Full analysis set (FAS) - only subjects treated in the respective pattern of respective injection cycle were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Flexed knee | 0.1 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Extended elbow | -0.2 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Extended knee | -0.1 units on a scale | Standard Deviation 0.4 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pes equinovarus | -0.1 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Internally rotated/extended/adducted shoulder | -0.0 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pes equinovalgus | -0.2 units on a scale | Standard Deviation 0.4 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pronated forearm | -0.3 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Flexed toes | -0.0 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Flexed wrist | -0.2 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Clenched fist | -0.2 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Thumb in palm | -0.2 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Flexed elbow | -0.2 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Adducted thigh | 0 units on a scale | Standard Deviation 0 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Internally rotated hip | -0.5 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Extended hallux | 0.0 units on a scale | Standard Deviation 1.2 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pronated forearm | -0.1 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Internally rotated/extended/adducted shoulder | 0.0 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Flexed knee | 0.4 units on a scale | Standard Deviation 1.2 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Flexed hip | -0.2 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Flexed wrist | -0.2 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Extended knee | 0.1 units on a scale | Standard Deviation 0.5 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Extended elbow | -0.1 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Clenched fist | -0.3 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pes equinovarus | -0.2 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Internally rotated hip | 0.3 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Adducted thigh | -0.3 units on a scale | Standard Deviation 0.5 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pes equinovalgus | -0.1 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Extended hallux | 0.6 units on a scale | Standard Deviation 1.3 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Thumb in palm | -0.3 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Flexed elbow | -0.3 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Flexed toes | 0.2 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Flexed toes | -0.4 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Flexed hip | -0.3 units on a scale | Standard Deviation 1.4 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pes equinovalgus | -0.4 units on a scale | Standard Deviation 0.5 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Internally rotated/extended/adducted shoulder | -0.3 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Flexed elbow | -0.8 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Extended elbow | -0.2 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pronated forearm | -0.7 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Clenched fist | -0.8 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Thumb in palm | -0.8 units on a scale | Standard Deviation 1.1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Adducted thigh | -0.4 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Internally rotated hip | 0.0 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Flexed knee | -0.4 units on a scale | Standard Deviation 1.1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Extended knee | -0.4 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pes equinovarus | -0.7 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Extended hallux | -0.2 units on a scale | Standard Deviation 1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Flexed wrist | -0.7 units on a scale | Standard Deviation 1 |
Secondary
Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Injection Cycle Baseline Visits to Respective Control Visits
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Population: Full analysis set (FAS), observed cases, only subjects treated in the target joint in the respective cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Injection Cycle Baseline Visits to Respective Control Visits | -0.8 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Injection Cycle Baseline Visits to Respective Control Visits | -0.8 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Injection Cycle Baseline Visits to Respective Control Visits | -0.9 units on a scale | Standard Deviation 0.9 |
Secondary
Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Control Visits of Injection Cycles
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: From Study Baseline to Week 4, 16-20 and 28-36
Population: Full analysis set (FAS), observed cases, only subjects treated in the target joint in the respective cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Control Visits of Injection Cycles | -0.8 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Control Visits of Injection Cycles | -1.0 units on a scale | Standard Deviation 0.9 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Control Visits of Injection Cycles | -1.3 units on a scale | Standard Deviation 1 |
Secondary
Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: From Study Baseline to Week 12-16, 24-32 and 36-48
Population: Full analysis set (FAS), observed cases, only subjects treated in the target joint in the respective cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | -0.2 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | -0.3 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | -0.7 units on a scale | Standard Deviation 0.9 |
Secondary
Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Injection Cycle Baseline Visits to Respective Control Visits
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.
Time frame: Week 4 of Each Cycle
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Injection Cycle Baseline Visits to Respective Control Visits | -0.6 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Injection Cycle Baseline Visits to Respective Control Visits | -0.7 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Injection Cycle Baseline Visits to Respective Control Visits | -0.7 units on a scale | Standard Deviation 0.8 |
Secondary
Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Control Visits of Injection Cycles
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.
Time frame: From Study Baseline to Week 4, 16-20 and 28-36
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Control Visits of Injection Cycles | -0.6 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Control Visits of Injection Cycles | -0.9 units on a scale | Standard Deviation 0.8 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Control Visits of Injection Cycles | -1.0 units on a scale | Standard Deviation 0.9 |
Secondary
Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit.
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.
Time frame: From Study Baseline to Week 12-16, 24-32 and 36-48
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit. | -0.2 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit. | -0.3 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit. | -0.9 units on a scale | Standard Deviation 0.9 |
Secondary
Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Mobility: Frequency 1 | 2 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Mobility: Frequency -1 | 18 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Usual activities: Frequency -1 | 20 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Anxiety/depression: Frequency 0 | 119 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Mobility: Frequency 0 | 135 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Usual activities: Frequency 0 | 126 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Pain/discomfort: Frequency 2 | 1 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Self-care: Frequency -1 | 19 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Usual activities: Frequency 1 | 9 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Anxiety/depression: Frequency 1 | 9 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Self-care: Frequency 1 | 13 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Pain/discomfort: Frequency -2 | 1 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Usual activities: Frequency -2 | 0 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Anxiety/depression: Frequency 2 | 0 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Pain/discomfort: Frequency -1 | 39 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Anxiety/depression:Frequency -1 | 27 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Self-care: Frequency 0 | 123 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Pain/discomfort: Frequency 0 | 105 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Anxiety/depression:Frequency -2 | 0 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Pain/discomfort: Frequency 1 | 9 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Self-care: Frequency 0 | 127 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Pain/discomfort: Frequency 1 | 12 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Mobility: Frequency -1 | 11 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Pain/discomfort: Frequency 2 | 0 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Anxiety/depression:Frequency -2 | 0 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Self-care: Frequency 1 | 14 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Anxiety/depression:Frequency -1 | 18 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Anxiety/depression: Frequency 0 | 121 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Anxiety/depression: Frequency 1 | 9 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Anxiety/depression: Frequency 2 | 1 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Usual activities: Frequency -2 | 0 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Mobility: Frequency 1 | 2 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Usual activities: Frequency -1 | 18 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Usual activities: Frequency 0 | 116 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Usual activities: Frequency 1 | 14 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Self-care: Frequency -1 | 7 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Pain/discomfort: Frequency -2 | 2 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Mobility: Frequency 0 | 136 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Pain/discomfort: Frequency -1 | 30 Subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Pain/discomfort: Frequency 0 | 105 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Anxiety/depression: Frequency 2 | 0 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Mobility: Frequency -1 | 6 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Mobility: Frequency 0 | 128 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Mobility: Frequency 1 | 4 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Self-care: Frequency -1 | 11 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Self-care: Frequency 0 | 121 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Self-care: Frequency 1 | 6 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Usual activities: Frequency -2 | 1 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Usual activities: Frequency -1 | 7 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Usual activities: Frequency 0 | 126 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Usual activities: Frequency 1 | 4 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Pain/discomfort: Frequency -2 | 0 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Pain/discomfort: Frequency -1 | 29 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Pain/discomfort: Frequency 0 | 102 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Pain/discomfort: Frequency 1 | 7 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Pain/discomfort: Frequency 2 | 0 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Anxiety/depression:Frequency -2 | 1 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Anxiety/depression:Frequency -1 | 17 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Anxiety/depression: Frequency 1 | 9 Subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | Anxiety/depression: Frequency 0 | 111 Subjects |
Secondary
Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.
Time frame: From Study Baseline to Week 4, 16-20 and 28-36
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Pain/discomfort: Frequency 1 | 9 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Self-care: Frequency 0 | 123 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Anxiety/depression:Frequency 1 | 9 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Pain/discomfort: Frequency -2 | 1 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Self-care: Frequency -1 | 19 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Anxiety/depression:Frequency 2 | 0 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Usual activities: Frequency 0 | 126 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Mobility: Frequency 1 | 2 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Mobility: Frequency -1 | 18 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Pain/discomfort: Frequency 2 | 1 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Mobility: Frequency 0 | 135 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Pain/discomfort: Frequency 0 | 105 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Usual activities: Frequency -1 | 20 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Anxiety/depression:Frequency -2 | 0 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Pain/discomfort: Frequency -1 | 39 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Usual activities: Frequency -2 | 0 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Anxiety/depression:Frequency -1 | 27 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Usual activities: Frequency 1 | 9 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Self-care: Frequency 1 | 13 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Anxiety/depression:Frequency 0 | 119 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Pain/discomfort: Frequency -2 | 3 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Pain/discomfort: Frequency -1 | 40 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Pain/discomfort: Frequency 0 | 93 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Pain/discomfort: Frequency 1 | 13 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Pain/discomfort: Frequency 2 | 0 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Anxiety/depression:Frequency -2 | 7 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Anxiety/depression:Frequency -1 | 28 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Anxiety/depression:Frequency 0 | 100 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Anxiety/depression:Frequency 1 | 14 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Anxiety/depression:Frequency 2 | 0 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Mobility: Frequency -1 | 16 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Mobility: Frequency 0 | 127 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Mobility: Frequency 1 | 5 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Self-care: Frequency -1 | 20 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Self-care: Frequency 0 | 110 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Self-care: Frequency 1 | 18 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Usual activities: Frequency -2 | 1 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Usual activities: Frequency -1 | 31 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Usual activities: Frequency 0 | 103 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Usual activities: Frequency 1 | 13 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Anxiety/depression:Frequency 0 | 85 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Usual activities: Frequency 0 | 98 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Self-care: Frequency 0 | 100 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Anxiety/depression:Frequency -1 | 32 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Pain/discomfort: Frequency 0 | 85 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Self-care: Frequency 1 | 13 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Anxiety/depression:Frequency -2 | 6 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Pain/discomfort: Frequency -2 | 3 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Usual activities: Frequency -2 | 1 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Pain/discomfort: Frequency 2 | 0 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Usual activities: Frequency 1 | 8 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Mobility: Frequency -1 | 14 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Usual activities: Frequency -1 | 31 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Mobility: Frequency 0 | 118 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Anxiety/depression:Frequency 2 | 0 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Pain/discomfort: Frequency 1 | 8 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Mobility: Frequency 1 | 5 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Anxiety/depression:Frequency 1 | 15 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Pain/discomfort: Frequency -1 | 42 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | Self-care: Frequency -1 | 25 subjects |
Secondary
Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.
Time frame: From Study Baseline to Week 12-16, 24-32 and 36-48
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pain/discomfort: Frequency 2 | 0 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Usual activities: Frequency -1 | 21 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Anxiety/depression: Frequency 2 | 1 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pain/discomfort: Frequency 1 | 20 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Usual activities: Frequency 0 | 125 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Self-care: Frequency -1 | 20 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pain/discomfort: Frequency 0 | 100 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Usual activities: Frequency 1 | 5 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Mobility: Frequency 0 | 137 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pain/discomfort: Frequency -1 | 32 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pain/discomfort: Frequency -2 | 0 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Anxiety/depression: Frequency 0 | 108 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Self-care: Frequency 0 | 120 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Mobility: Frequency -1 | 10 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Anxiety/depression: Frequency -1 | 29 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Self-care: Frequency 1 | 12 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Anxiety/depression: Frequency 1 | 12 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Anxiety/depression: Frequency -2 | 2 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Usual activities: Frequency -2 | 1 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Mobility: Frequency 1 | 5 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Anxiety/depression: Frequency 0 | 91 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Mobility: Frequency -1 | 13 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Mobility: Frequency 0 | 121 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Mobility: Frequency 1 | 5 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Self-care: Frequency -1 | 24 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Self-care: Frequency 0 | 99 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Self-care: Frequency 1 | 17 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Usual activities: Frequency -2 | 1 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Usual activities: Frequency -1 | 26 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Usual activities: Frequency 0 | 106 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Usual activities: Frequency 1 | 7 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pain/discomfort: Frequency -2 | 0 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pain/discomfort: Frequency -1 | 35 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pain/discomfort: Frequency 0 | 89 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pain/discomfort: Frequency 1 | 15 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pain/discomfort: Frequency 2 | 1 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Anxiety/depression: Frequency -2 | 4 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Anxiety/depression: Frequency -1 | 28 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Anxiety/depression: Frequency 1 | 17 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Anxiety/depression: Frequency 2 | 0 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Mobility: Frequency 0 | 116 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pain/discomfort: Frequency 1 | 13 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Usual activities: Frequency -2 | 1 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Anxiety/depression: Frequency 2 | 0 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pain/discomfort: Frequency 2 | 0 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Self-care: Frequency 1 | 10 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Anxiety/depression: Frequency 1 | 13 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Anxiety/depression: Frequency -2 | 5 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Self-care: Frequency 0 | 97 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Mobility: Frequency -1 | 16 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Anxiety/depression: Frequency -1 | 30 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Self-care: Frequency -1 | 30 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pain/discomfort: Frequency -2 | 3 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Usual activities: Frequency 1 | 7 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Mobility: Frequency 1 | 4 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pain/discomfort: Frequency -1 | 40 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Usual activities: Frequency 0 | 96 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Anxiety/depression: Frequency 0 | 89 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Pain/discomfort: Frequency 0 | 81 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | Usual activities: Frequency -1 | 33 subjects |
Secondary
Change of Functional Ambulation Classification (FAC) Score From Injection Cycle Baseline Visits to Respective Control Visits
The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Functional Ambulation Classification (FAC) Score From Injection Cycle Baseline Visits to Respective Control Visits | 0.1 units on a scale | Standard Deviation 0.5 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Functional Ambulation Classification (FAC) Score From Injection Cycle Baseline Visits to Respective Control Visits | 0.1 units on a scale | Standard Deviation 0.4 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Functional Ambulation Classification (FAC) Score From Injection Cycle Baseline Visits to Respective Control Visits | 0.1 units on a scale | Standard Deviation 0.4 |
Secondary
Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Control Visits of Injection Cycles
The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.
Time frame: From Study Baseline to Week 4, 16-20 and 28-36
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Control Visits of Injection Cycles | 0.1 units on a scale | Standard Deviation 0.5 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Control Visits of Injection Cycles | 0.3 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Control Visits of Injection Cycles | 0.4 units on a scale | Standard Deviation 0.7 |
Secondary
Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit
The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.
Time frame: From Study Baseline to Week 12-16, 24-32 and 36-48
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | 0.2 units on a scale | Standard Deviation 0.5 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | 0.3 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | 0.4 units on a scale | Standard Deviation 0.8 |
Secondary
Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Injection Cycle Baseline Visits to Respective Control Visits
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Injection Cycle Baseline Visits to Respective Control Visits | -4.6 units on a scale | Standard Deviation 3.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Injection Cycle Baseline Visits to Respective Control Visits | -5.9 units on a scale | Standard Deviation 4.2 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Injection Cycle Baseline Visits to Respective Control Visits | -7.1 units on a scale | Standard Deviation 4.8 |
Secondary
Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Control Visits of Injection Cycles
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.
Time frame: From Study Baseline to Week 4, 16-20 and 28-36
Population: The full analysis set is the subset of all subjects who were exposed to study medication at least once.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Control Visits of Injection Cycles | -4.6 units on a scale | Standard Deviation 3.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Control Visits of Injection Cycles | -6.7 units on a scale | Standard Deviation 4.6 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Control Visits of Injection Cycles | -9.0 units on a scale | Standard Deviation 5.5 |
Secondary
Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.
Time frame: From Study Baseline to Week 12-16, 24-32 and 36-48
Population: The full analysis set is the subset of all subjects who were exposed to study medication at least once.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | -0.8 units on a scale | Standard Deviation 4.2 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | -1.9 units on a scale | Standard Deviation 4.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | -5.5 units on a scale | Standard Deviation 5.3 |
Secondary
Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value.
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb | 2.6 units on a scale | Standard Deviation 0.5 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb | 2.0 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb | 2.4 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb | 1.7 units on a scale | Standard Deviation 0.7 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb | 2.2 units on a scale | Standard Deviation 0.6 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb | 1.5 units on a scale | Standard Deviation 0.7 |
Secondary
EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems.
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 3 | 4 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 2 | 139 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 2 | 113 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 1 | 72 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 1 | 11 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 3 | 31 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 2 | 85 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 1 | 53 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 3 | 29 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 1 | 12 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 2 | 69 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 2 | 96 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 3 | 17 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 1 | 30 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 3 | 14 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 3 | 7 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 3 | 3 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 2 | 125 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 1 | 27 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 2 | 67 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 3 | 28 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 2 | 75 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 1 | 73 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 2 | 108 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 3 | 6 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 2 | 100 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 1 | 19 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 3 | 24 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 1 | 82 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 1 | 31 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 2 | 101 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 1 | 14 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 2 | 63 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 2 | 88 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 3 | 8 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 1 | 83 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 3 | 6 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 2 | 136 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 3 | 2 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 1 | 30 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 3 | 21 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 1 | 16 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 2 | 119 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 3 | 17 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 1 | 56 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 1 | 93 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 3 | 3 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 3 | 5 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 3 | 20 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 2 | 122 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 1 | 21 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 1 | 24 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 3 | 7 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 1 | 24 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 3 | 17 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 2 | 49 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 2 | 110 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 2 | 104 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 2 | 70 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 1 | 74 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 3 | 4 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 3 | 2 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 2 | 57 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 1 | 57 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 1 | 24 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 2 | 101 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 1 | 78 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 3 | 15 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 1 | 15 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 2 | 79 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 2 | 113 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 1 | 19 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 3 | 12 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 2 | 119 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 3 | 5 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 1 | 85 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 2 | 116 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 2 | 111 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 2 | 49 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 2 | 58 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 1 | 77 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 3 | 2 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Mobility: Frequency 1 | 20 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Pain/discomfort: Frequency 3 | 3 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 3 | 9 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 3 | 10 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Usual activities: Frequency 1 | 17 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 1 | 22 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Anxiety/depression: Frequency 3 | 4 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | Self-care: Frequency 2 | 107 subjects |
Secondary
Functional Ambulation Classification (FAC) Scale Scores
The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Functional Ambulation Classification (FAC) Scale Scores | 3.5 units on a scale | Standard Deviation 1.4 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Functional Ambulation Classification (FAC) Scale Scores | 3.7 units on a scale | Standard Deviation 1.3 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Functional Ambulation Classification (FAC) Scale Scores | 3.7 units on a scale | Standard Deviation 1.3 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Functional Ambulation Classification (FAC) Scale Scores | 3.8 units on a scale | Standard Deviation 1.3 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Functional Ambulation Classification (FAC) Scale Scores | 3.8 units on a scale | Standard Deviation 1.3 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Functional Ambulation Classification (FAC) Scale Scores | 3.9 units on a scale | Standard Deviation 1.2 |
Secondary
Global Assessment of Efficacy Scores
Investigator assessment. The global assessment of efficacy will be assessed by the investigator, the subject, and the caregiver using a 4-point Likert scale with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.
Time frame: Week 12-16, 24-32 and 36-48
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Global Assessment of Efficacy Scores | Frequency 4 (poor) | 3 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Global Assessment of Efficacy Scores | Missing | 3 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Global Assessment of Efficacy Scores | Frequency 3 (moderate) | 63 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Global Assessment of Efficacy Scores | Frequency 2 (good) | 79 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Global Assessment of Efficacy Scores | Frequency 1 (very good) | 7 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Global Assessment of Efficacy Scores | Frequency 4 (poor) | 3 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Global Assessment of Efficacy Scores | Frequency 1 (very good) | 21 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Global Assessment of Efficacy Scores | Frequency 2 (good) | 89 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Global Assessment of Efficacy Scores | Missing | 11 subjects |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Global Assessment of Efficacy Scores | Frequency 3 (moderate) | 28 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Global Assessment of Efficacy Scores | Missing | 3 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Global Assessment of Efficacy Scores | Frequency 1 (very good) | 38 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Global Assessment of Efficacy Scores | Frequency 3 (moderate) | 11 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Global Assessment of Efficacy Scores | Frequency 4 (poor) | 1 subjects |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Global Assessment of Efficacy Scores | Frequency 2 (good) | 87 subjects |
Secondary
Goal Attainment Scale (GAS) Scores for Upper and Lower Limb, Respectively
Change in goal attainment T-scores from respective injection cycle baseline visit. GAS measures the extent to which subject's individual goals are achieved in course of intervention. Subject and treating team have to identify 2 personal goals for each treated limb at each injection cycle. Investigator rates the GAS score for each injection cycle. Degree of goal attainment is rated on 5-point scale (-2, -1, 0, +1, +2; study baseline set to -1) and in order to account for interindividual differences in the number of goals, ratings are computed with the Kiresuk formula (Kiresuk & Sherman, Community Mental Health Journal. 1968;4(6):443-53) resulting in T-scores measuring the degree of goal attainment at each visit. A score of 50 indicates that the individual has reached the expected level of achievement for all goals. The size of change from measurement to measurement indicates incremental change towards or away from goal attainment. Positive values indicate a higher goal attainment.
Time frame: From Cycle Baseline Visit to Week 12-16, 24-32 and 36-48
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Goal Attainment Scale (GAS) Scores for Upper and Lower Limb, Respectively | Upper limb | 7.178 units on a scale | Standard Deviation 9.254 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Goal Attainment Scale (GAS) Scores for Upper and Lower Limb, Respectively | Lower limb | 8.222 units on a scale | Standard Deviation 9.649 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Goal Attainment Scale (GAS) Scores for Upper and Lower Limb, Respectively | Lower limb | 10.914 units on a scale | Standard Deviation 9.251 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Goal Attainment Scale (GAS) Scores for Upper and Lower Limb, Respectively | Upper limb | 10.601 units on a scale | Standard Deviation 9.211 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Goal Attainment Scale (GAS) Scores for Upper and Lower Limb, Respectively | Lower limb | 13.579 units on a scale | Standard Deviation 10.196 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Goal Attainment Scale (GAS) Scores for Upper and Lower Limb, Respectively | Upper limb | 13.028 units on a scale | Standard Deviation 8.765 |
Secondary
Resistance to Passive Movement Scale (REPAS) Scores of Treated Side
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Resistance to Passive Movement Scale (REPAS) Scores of Treated Side | 24.8 units on a scale | Standard Deviation 6.7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Resistance to Passive Movement Scale (REPAS) Scores of Treated Side | 20.2 units on a scale | Standard Deviation 7.1 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Resistance to Passive Movement Scale (REPAS) Scores of Treated Side | 24.0 units on a scale | Standard Deviation 7 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Resistance to Passive Movement Scale (REPAS) Scores of Treated Side | 18.1 units on a scale | Standard Deviation 7.6 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Resistance to Passive Movement Scale (REPAS) Scores of Treated Side | 22.9 units on a scale | Standard Deviation 7.2 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Resistance to Passive Movement Scale (REPAS) Scores of Treated Side | 15.7 units on a scale | Standard Deviation 7.6 |
Secondary
Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome).
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Population: Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | 59.9 units on a scale | Standard Deviation 18.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | 66.7 units on a scale | Standard Deviation 17.6 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | 67.2 units on a scale | Standard Deviation 17 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | 69.9 units on a scale | Standard Deviation 16.6 |
| IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | 67.1 units on a scale | Standard Deviation 17.9 |
| IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 | Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | 68.9 units on a scale | Standard Deviation 17.7 |