Post-stroke Spasticity of the Upper Limb
Conditions
Brief summary
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.
Detailed description
The study consists of a randomized, double-blind, placebo-controlled, parallel-group, single-dose main period followed by an open-label, non-controlled, repeated-dose extension period (Open-Label Extension Period - OLEX).
Interventions
Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection
DRUGPlacebo Comparator
Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection
Sponsors
Merz Pharmaceuticals GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Upper limb spasticity * Time since stroke greater than 3 months * Need for 400 U Botulinum toxin type A
Exclusion criteria
* Body weight below 50kg * Fixed contractures of the upper limb * 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 |
|---|---|---|
| Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern | Week 4 | Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Investigator's Global Impression of Change | Week 4 | This is the co-primary outcome measure. The Global Impression of Change Scale \[GICS\] is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern | Week 12 | Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist | Week 4 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist | Week 8 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist | Week 12 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow | Week 4 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow | Week 8 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow | Week 12 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist | Week 4 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist | Week 8 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist | Week 12 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm | Week 4 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm | Week 8 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm | Week 12 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm | Week 4 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm | Week 8 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm | Week 12 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. | Week 4 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. | Week 8 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. | Week 12 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. | Week 4 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. | Week 8 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. | Week 12 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. | Week 4 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. | Week 8 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. | Week 12 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. | Week 4 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. | Week 8 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. | Week 12 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. | Week 4 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. | Week 8 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. | Week 12 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain | Week 4 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain | Week 8 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain | Week 12 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene | Week 4 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene | Week 8 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene | Week 12 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing | Week 4 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing | Week 8 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing | Week 12 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position | Week 4 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern | Week 4 | Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position | Week 12 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain | Week 4 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain | Week 8 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain | Week 12 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position | Week 8 | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). |
| Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern | Week 8 | Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
Countries
Czechia, Germany, Hungary, India, Poland, Russia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment | 210 |
| Double-blind Placebo Comparator Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment | 107 |
| Total | 317 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Main Period (MP) | Lost to Follow-up | 3 | 3 | 0 |
| Main Period (MP) | Non-compliance | 1 | 0 | 0 |
| Main Period (MP) | Predefined discontinuation criteria | 2 | 3 | 0 |
| Main Period (MP) | Withdrawal by Subject | 5 | 1 | 0 |
| Open Label Extension (OLEX) Period | Adverse Event | 0 | 0 | 7 |
| Open Label Extension (OLEX) Period | Death | 0 | 0 | 4 |
| Open Label Extension (OLEX) Period | Lack of Efficacy | 0 | 0 | 3 |
| Open Label Extension (OLEX) Period | Lost to Follow-up | 0 | 0 | 6 |
| Open Label Extension (OLEX) Period | Non-compliance | 0 | 0 | 1 |
| Open Label Extension (OLEX) Period | Protocol Violation | 0 | 0 | 13 |
| Open Label Extension (OLEX) Period | Withdrawal by Subject | 0 | 0 | 17 |
Baseline characteristics
| Characteristic | Double-blind Placebo Comparator | Total | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) |
|---|---|---|---|
| Age, Continuous | 57.8 years STANDARD_DEVIATION 10.9 | 56.1 years STANDARD_DEVIATION 11.6 | 55.3 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 34 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 95 Participants | 279 Participants | 184 Participants |
| Gender Female | 61 Participants | 181 Participants | 120 Participants |
| Gender Male | 46 Participants | 136 Participants | 90 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 40 Participants | 27 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 91 Participants | 266 Participants | 175 Participants |
| Region of Enrollment Czech Republic | 25 participants | 71 participants | 46 participants |
| Region of Enrollment Germany | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Hungary | 9 participants | 32 participants | 23 participants |
| Region of Enrollment India | 13 participants | 39 participants | 26 participants |
| Region of Enrollment Poland | 38 participants | 104 participants | 66 participants |
| Region of Enrollment Russian Federation | 10 participants | 32 participants | 22 participants |
| Region of Enrollment United States | 12 participants | 38 participants | 26 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 210 | 4 / 107 | 32 / 296 |
| serious Total, serious adverse events | 7 / 210 | 2 / 107 | 22 / 296 |
Outcome results
Primary
Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern | -0.9 units on a scale | Standard Error 0.06 |
| Double-blind Placebo Comparator | Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern | -0.5 units on a scale | Standard Error 0.08 |
p-value: <0.00195% CI: [-0.7, -0.3]ANCOVA
Primary
Investigator's Global Impression of Change
This is the co-primary outcome measure. The Global Impression of Change Scale \[GICS\] is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved.
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by zero change (worst case).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Investigator's Global Impression of Change | 1.2 units on a scale | Standard Error 0.07 |
| Double-blind Placebo Comparator | Investigator's Global Impression of Change | 0.9 units on a scale | Standard Error 0.09 |
p-value: 0.00395% CI: [0.1, 0.5]ANCOVA
Secondary
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 12
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. | -0.3 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. | -0.1 units on a scale | Standard Error 0.07 |
p-value: 0.13795% CI: [-0.3, 0]ANCOVA
Secondary
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 12
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. | -0.4 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. | -0.2 units on a scale | Standard Error 0.07 |
p-value: 0.02995% CI: [-0.3, 0]ANCOVA
Secondary
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 12
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. | -0.3 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. | -0.1 units on a scale | Standard Error 0.07 |
p-value: 0.03295% CI: [-0.3, 0]ANCOVA
Secondary
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 12
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. | -0.3 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. | -0.1 units on a scale | Standard Error 0.07 |
p-value: 0.06295% CI: [-0.3, 0]ANCOVA
Secondary
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 12
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. | -0.2 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. | -0.1 units on a scale | Standard Error 0.07 |
p-value: 0.71495% CI: [-0.2, 0.1]ANCOVA
Secondary
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 12
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing | -0.3 units on a scale | Standard Error 0.04 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing | -0.1 units on a scale | Standard Error 0.06 |
p-value: 0.10595% CI: [-0.3, 0]ANCOVA
Secondary
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 12
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene | -0.3 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene | -0.1 units on a scale | Standard Error 0.07 |
p-value: 0.1495% CI: [-0.3, 0]ANCOVA
Secondary
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 12
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position | -0.4 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position | -0.3 units on a scale | Standard Error 0.06 |
p-value: 0.2295% CI: [-0.2, 0.1]ANCOVA
Secondary
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 12
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain | -0.3 units on a scale | Standard Error 0.06 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain | -0.2 units on a scale | Standard Error 0.09 |
p-value: 0.84495% CI: [-0.2, 0.2]ANCOVA
Secondary
Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 12
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain | -0.4 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain | -0.4 units on a scale | Standard Error 0.06 |
p-value: 0.41695% CI: [-0.2, 0.1]ANCOVA
Secondary
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. | -0.7 units on a scale | Standard Error 0.06 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. | -0.3 units on a scale | Standard Error 0.08 |
p-value: <0.00195% CI: [-0.5, -0.2]ANCOVA
Secondary
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. | -0.7 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. | -0.3 units on a scale | Standard Error 0.07 |
p-value: <0.00195% CI: [-0.6, -0.2]ANCOVA
Secondary
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. | -0.8 units on a scale | Standard Error 0.06 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. | -0.5 units on a scale | Standard Error 0.08 |
p-value: <0.00195% CI: [-0.5, -0.2]ANCOVA
Secondary
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. | -0.5 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. | -0.2 units on a scale | Standard Error 0.07 |
p-value: <0.00195% CI: [-0.5, -0.2]ANCOVA
Secondary
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. | -0.4 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. | -0.2 units on a scale | Standard Error 0.07 |
p-value: 0.01395% CI: [-0.4, 0]ANCOVA
Secondary
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing | -0.4 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing | -0.2 units on a scale | Standard Error 0.06 |
p-value: 0.00795% CI: [-0.4, -0.1]ANCOVA
Secondary
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene | -0.4 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene | -0.1 units on a scale | Standard Error 0.06 |
p-value: <0.00195% CI: [-0.4, -0.1]ANCOVA
Secondary
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position | -0.5 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position | -0.3 units on a scale | Standard Error 0.07 |
p-value: 0.01695% CI: [-0.4, 0]ANCOVA
Secondary
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain | -0.2 units on a scale | Standard Error 0.06 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain | -0.2 units on a scale | Standard Error 0.08 |
p-value: 0.42995% CI: [-0.2, 0.1]ANCOVA
Secondary
Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain | -0.5 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain | -0.3 units on a scale | Standard Error 0.07 |
p-value: 0.00695% CI: [-0.4, -0.1]ANCOVA
Secondary
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 8
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. | -0.6 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. | -0.4 units on a scale | Standard Error 0.08 |
p-value: 0.01995% CI: [-0.4, 0]ANCOVA
Secondary
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 8
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. | -0.6 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. | -0.3 units on a scale | Standard Error 0.07 |
p-value: <0.00195% CI: [-0.5, -0.1]ANCOVA
Secondary
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 8
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. | -0.6 units on a scale | Standard Error 0.06 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. | -0.4 units on a scale | Standard Error 0.08 |
p-value: 0.01195% CI: [-0.4, -0.1]ANCOVA
Secondary
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 8
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. | -0.4 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. | -0.2 units on a scale | Standard Error 0.07 |
p-value: 0.00895% CI: [-0.4, -0.1]ANCOVA
Secondary
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: Week 8
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. | -0.3 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. | -0.2 units on a scale | Standard Error 0.08 |
p-value: 0.13195% CI: [-0.3, 0]ANCOVA
Secondary
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 8
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing | -0.4 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing | -0.2 units on a scale | Standard Error 0.07 |
p-value: 0.01895% CI: [-0.3, 0]ANCOVA
Secondary
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 8
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene | -0.4 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene | -0.2 units on a scale | Standard Error 0.07 |
p-value: 0.17595% CI: [-0.3, 0.1]ANCOVA
Secondary
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 8
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position | -0.4 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position | -0.2 units on a scale | Standard Error 0.07 |
p-value: 0.01495% CI: [-0.4, 0]ANCOVA
Secondary
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 8
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain | -0.2 units on a scale | Standard Error 0.06 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain | -0.2 units on a scale | Standard Error 0.08 |
p-value: 0.88495% CI: [-0.2, 0.2]ANCOVA
Secondary
Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Week 8
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain | -0.5 units on a scale | Standard Error 0.05 |
| Double-blind Placebo Comparator | Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain | -0.3 units on a scale | Standard Error 0.07 |
p-value: 0.07695% CI: [-0.3, 0]ANCOVA
Secondary
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 12
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist | 49 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist | 19 participants |
p-value: 0.06995% CI: [0.95, 3.69]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 12
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow | 52 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow | 21 participants |
p-value: 0.10295% CI: [0.9, 3.22]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 12
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist | 59 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist | 17 participants |
p-value: 0.00695% CI: [1.32, 5.05]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 12
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm | 51 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm | 15 participants |
p-value: 0.01895% CI: [1.15, 4.41]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 12
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm | 35 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm | 20 participants |
p-value: 0.9295% CI: [0.49, 2.18]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 12
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern | 68 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern | 22 participants |
p-value: 0.00495% CI: [1.33, 4.61]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist | 90 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist | 26 participants |
p-value: <0.00195% CI: [1.67, 5.23]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow | 99 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow | 28 participants |
p-value: <0.00195% CI: [2.06, 6.72]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist | 102 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist | 31 participants |
p-value: <0.00195% CI: [1.76, 5.57]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm | 73 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm | 19 participants |
p-value: <0.00195% CI: [1.83, 6.91]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm | 56 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm | 21 participants |
p-value: 0.03495% CI: [1.05, 4]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 4
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern | 119 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern | 33 participants |
p-value: <0.00195% CI: [2.43, 7.52]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 8
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist | 82 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist | 27 participants |
p-value: 0.00295% CI: [1.37, 4.41]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 8
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow | 85 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow | 28 participants |
p-value: 0.00295% CI: [1.4, 4.46]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 8
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist | 90 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist | 33 participants |
p-value: 0.02195% CI: [1.1, 3.34]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 8
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm | 64 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm | 20 participants |
p-value: 0.00795% CI: [1.28, 4.56]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 8
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm | 52 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm | 23 participants |
p-value: 0.16995% CI: [0.82, 3.16]Regression, Logistic
Secondary
Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Time frame: Week 8
Population: Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern | 104 participants |
| Double-blind Placebo Comparator | Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern | 34 participants |
p-value: <0.00195% CI: [1.56, 4.63]Regression, Logistic