Post-stroke Upper Limb Spasticity
Conditions
Brief summary
IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free from complexing proteins, i.e. free from proteins other than the active toxin. Injected into the muscle, incobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for treatment of various neurological conditions. This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of post-stroke spasticity of the upper limb.
Interventions
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 dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to five injections in the Open-Label Extension Period, up to 400 units at each injection visit; Mode of administration: intramuscular injection
DRUGPlacebo
Placebo
Sponsors
Merz Pharmaceuticals GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Female or male patients ≥ 18 years * ≥ 6 months since the last stroke, diagnosed by an appropriate health care professional (e.g., neurologist) * Focal spasticity with ≥ 2 points on the Ashworth Scale in the wrist flexors with clinical pattern Flexed Wrist * Focal spasticity with ≥ 2 points on the Ashworth Scale in the fingers flexors with clinical pattern Clenched Fist * For pre-treated patients only: source documentation of the most recent injection session with Botulinum Toxin and sufficient therapeutic response for Flexed Wrist and Clenched Fist * For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 50 Units BOTOX® or 200 Units Dysport® or 2000 Units Neurobloc® (type B preparation) per each of these flexors: carpi ulnaris, digitorum superficialis, digitorum profundus * For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 60 Units BOTOX® or 240 Units Dysport® or 2400 Units Neurobloc® (type B preparation) for flexor carpi radialis Main
Exclusion criteria
* Spasticity of any other origin than stroke * Previous treatment with Botulinum Toxin of any serotype and for any body region within the 4 months prior to Screening (Visit 1, Day -7) * Planned concomitant treatment with Botulinum Toxin of any serotype and for any body region * Previous or planned treatment with phenol- or alcohol-injection in the target limb * Previous surgical treatment of spasticity in the target muscle(s) * Fixed contracture, defined as severe restriction of the range of joint movement on passive stretch * Severe atrophy of the target limb muscles
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors | Baseline, Week 4 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responders at Week 4 Based on a Responder Definition of at Least 2 Points Improvement From Baseline in the Ashworth Score for Wrist Flexors | Baseline, Week 4 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits | Baseline, Week 2, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits | Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits | Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits | Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits | Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors | Baseline, Week 2 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors | Baseline, Week 4 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors | Baseline, Week 8 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors | Baseline, Week 12 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors | Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators | Baseline, Week 2 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators | Baseline, Week 4 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators | Baseline, Week 8 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators | Baseline, Week 12 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators | Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors | Baseline, Week 2 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors | Baseline, Week 4 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors | Baseline, Week 8 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors | Baseline, Week 12 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors | Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors | Baseline, Week 2 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors | Baseline, Week 4 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors | Baseline, Week 8 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors | Baseline, Week 12 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors | Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors | Baseline, Week 2 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors | Baseline, Week 4 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors | Baseline, Week 8 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors | Baseline, Week 12 | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors | Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis. |
| Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene | Baseline, Week 2 | 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 to Onset of Treatment Effect | Period starting at Visit 2 (baseline injection) of the Main Period up to onset of treatment effect | Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if yes: when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was yes or until the final visit of the Main Period was performed. For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period. |
| Time to Waning of Treatment Effect | Defined as time (weeks) from Visit 2 (injection session at Baseline, Day 0) to the subjective estimation of the waning of the effect | Subject who reported an onset of treatment effect were asked at each visit/telephone contact starting at week 4 at earliest if he/she felt that there was a waning of the treatment effect. The same question was asked at each of the following telephone contacts and visits (up to the Final Visit of the Main Period) if the answer at the respective previous visit was no. If the patient answered with yes he/she will be asked at which week after the injection (= the time span in weeks) the waning of effect occurred. For all subjects without an onset of treatment effect the waning was set to zero. |
| Duration of Treatment Effect | Period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator | The duration of treatment effect is defined as the time period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator. For subjects without any treatment effect the duration of effect was set to zero. |
| Investigator's Global Assessment of Efficacy | Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Investigator's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor. |
| Patient's Global Assessment of Efficacy | Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Patient's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor. |
| Carer's Global Assessment of Efficacy | Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Carer's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor. |
| Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target | Baseline, Week 2 | 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). |
| Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target | Baseline, 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). |
| Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target | Baseline, 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). |
| Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target | Baseline, 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). |
| Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target | Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | 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). |
| Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene | Baseline, 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). |
| Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene | Baseline, 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). |
| Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene | Baseline, 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). |
| Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene | Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | 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). |
| Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing | Baseline, Week 2 | 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). |
| Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing | Baseline, 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). |
| Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing | Baseline, 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). |
| Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing | Baseline, 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). |
| Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing | Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | 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). |
| Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position | Baseline, Week 2 | 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). |
| Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position | Baseline, 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). |
| Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position | Baseline, 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). |
| Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position | Baseline, 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). |
| Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position | Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | 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). |
| Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain | Baseline, Week 2 | 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). |
| Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain | Baseline, 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). |
| Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain | Baseline, 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). |
| Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain | Baseline, 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). |
| Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain | Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | 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). |
| Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Baseline, Week 4 | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Baseline, Week 12 | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Baseline, Week 4 | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Baseline, Week 12 | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Baseline, Week 12 | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Baseline, Week 4 | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Baseline, Week 12 | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Baseline, Week 4 | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Baseline, Week 12 | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
| Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Baseline, Week 4 | The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Onset of Treatment Effect [Classified] | Period starting at baseline injection of the Main Period up to onset of treatment effect | Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if yes: when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was yes or until the final visit of the Main Period was performed. For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period. |
Countries
Czechia, Hungary, Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| incobotulinumtoxinA (Xeomin) incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection | 73 |
| Placebo Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection | 75 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Main Period | Adverse Event | 1 | 1 |
| Main Period | Consent Withdrawn | 1 | 0 |
| Open-Label Extension Period | Adverse Event | 5 | 0 |
| Open-Label Extension Period | Consent withdrawn | 10 | 0 |
| Open-Label Extension Period | Lack of Efficacy | 6 | 0 |
| Open-Label Extension Period | Physician Decision | 3 | 0 |
| Open-Label Extension Period | Withdrawal Criteria Occurred | 1 | 0 |
Baseline characteristics
| Characteristic | incobotulinumtoxinA (Xeomin) | Placebo | Total |
|---|---|---|---|
| Age Continuous | 58.1 years STANDARD_DEVIATION 10.2 | 53.3 years STANDARD_DEVIATION 13.3 | 55.6 years STANDARD_DEVIATION 12.1 |
| Sex: Female, Male Female | 28 Participants | 25 Participants | 53 Participants |
| Sex: Female, Male Male | 45 Participants | 50 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 73 | 5 / 75 |
| serious Total, serious adverse events | 4 / 73 | 1 / 75 |
Outcome results
Primary
Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were not imputed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| incobotulinumtoxinA (Xeomin) | Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors | 50 Participants |
| Placebo | Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors | 28 Participants |
Comparison: The null hypothesis was equality of the chance (OR = 1) for a clinically relevant treatment effect between incobotulinumtoxinA (Xeomin) and placebo at Week 4 for wrist flexors. Responders were defined as subjects with an improvement of at least 1 point in the Ashworth score compared with Baseline. The dependent variable was the response to treatment, the independent variables were treatment, Ashworth score at the Baseline Visit, pre-treated patient status, gender, age, BMI, and pooled sites.p-value: <0.00195% CI: [1.9, 8.3]Regression, Logistic
Secondary
Carer's Global Assessment of Efficacy
The Carer's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.
Time frame: Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Carer's Global Assessment of Efficacy | Good | 21 Participants |
| incobotulinumtoxinA (Xeomin) | Carer's Global Assessment of Efficacy | Poor | 8 Participants |
| incobotulinumtoxinA (Xeomin) | Carer's Global Assessment of Efficacy | Very good | 8 Participants |
| incobotulinumtoxinA (Xeomin) | Carer's Global Assessment of Efficacy | No carer | 26 Participants |
| incobotulinumtoxinA (Xeomin) | Carer's Global Assessment of Efficacy | Moderate | 9 Participants |
| incobotulinumtoxinA (Xeomin) | Carer's Global Assessment of Efficacy | Missing | 1 Participants |
| Placebo | Carer's Global Assessment of Efficacy | Missing | 3 Participants |
| Placebo | Carer's Global Assessment of Efficacy | Very good | 2 Participants |
| Placebo | Carer's Global Assessment of Efficacy | Good | 17 Participants |
| Placebo | Carer's Global Assessment of Efficacy | Moderate | 10 Participants |
| Placebo | Carer's Global Assessment of Efficacy | Poor | 24 Participants |
| Placebo | Carer's Global Assessment of Efficacy | No carer | 19 Participants |
Secondary
Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors | Change of -3 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors | Change of 0 points | 39 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors | Change of -2 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors | Change of +1 points | 5 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors | Missing | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors | Change of -1 points | 26 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors | Missing | 2 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors | Change of -1 points | 16 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors | Change of 0 points | 51 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors | Change of +1 points | 5 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors | Change of -3 points | 0 Participants |
Secondary
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors | Change of -3 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors | Change of -1 points | 19 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors | Change of 0 points | 32 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors | Change of +1 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors | Change of -2 points | 2 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors | Missing | 1 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors | Change of -2 points | 0 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors | Change of +1 points | 3 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors | Change of -1 points | 14 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors | Change of 0 points | 37 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors | Change of -3 points | 0 Participants |
Secondary
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators | Change of -2 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators | Change of 0 points | 22 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators | Change of -3 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators | Change of +1 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators | Change of -1 points | 9 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators | Missing | 1 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators | Missing | 2 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators | Change of -1 points | 8 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators | Change of 0 points | 21 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators | Change of +1 points | 6 Participants |
Secondary
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors | Change of 0 points | 13 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors | Change of +1 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors | Change of -1 points | 9 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors | Change of -2 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors | Missing | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors | Missing | 2 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors | Change of -3 points | 1 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors | Change of -2 points | 0 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors | Change of -1 points | 9 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors | Change of 0 points | 14 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors | Change of +1 points | 4 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors | Change of +2 points | 1 Participants |
Secondary
Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors | Change of -3 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors | Change of -2 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors | Change of -1 points | 27 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors | Change of 0 points | 39 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors | Change of +1 points | 4 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors | Missing | 1 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors | Change of +1 points | 7 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors | Change of 0 points | 50 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors | Change of -2 points | 0 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors | Missing | 2 Participants |
| Placebo | Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors | Change of -1 points | 14 Participants |
Secondary
Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | No carer | 27 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | No longer necessary | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Less difficult | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Unchanged | 41 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | More difficult | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Required for the first time | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Missing | 0 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Missing | 2 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | No carer | 22 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Unchanged | 45 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Required for the first time | 2 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | No longer necessary | 1 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | More difficult | 1 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Less difficult | 2 Participants |
Secondary
Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Less difficult | 12 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | More difficult | 6 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | No longer necessary | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Required for the first time | 4 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Unchanged | 23 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | No carer | 27 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Missing | 2 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | No carer | 22 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | No longer necessary | 2 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Less difficult | 6 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Unchanged | 32 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | More difficult | 9 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Required for the first time | 2 Participants |
Secondary
Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Less difficult | 8 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | More difficult | 9 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | No longer necessary | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Required for the first time | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Unchanged | 26 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | No carer | 27 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Missing | 2 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | No longer necessary | 0 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | No carer | 22 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Less difficult | 4 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Unchanged | 36 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | More difficult | 5 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Required for the first time | 6 Participants |
Secondary
Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Less difficult | 12 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | More difficult | 12 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | No longer necessary | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Required for the first time | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Unchanged | 21 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | No carer | 27 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Missing | 2 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | No carer | 22 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | No longer necessary | 1 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Less difficult | 12 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Unchanged | 26 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | More difficult | 10 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Required for the first time | 2 Participants |
Secondary
Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Less difficult | 16 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | More difficult | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | No longer necessary | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Required for the first time | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Unchanged | 24 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | No carer | 27 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Missing | 2 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | No carer | 22 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | No longer necessary | 4 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Less difficult | 10 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Unchanged | 29 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | More difficult | 6 Participants |
| Placebo | Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Required for the first time | 2 Participants |
Secondary
Change From Baseline to Final Visit in the Disability Assessment Scale for 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: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing | Change of -1 points | 14 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing | Change of +1 points | 5 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing | Change of -2 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing | Change of 0 points | 50 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing | Missing | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing | Missing | 2 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing | Change of -2 points | 2 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing | Change of -1 points | 16 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing | Change of 0 points | 51 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing | Change of +1 points | 4 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing | Change of +2 points | 0 Participants |
Secondary
Change From Baseline to Final Visit in the Disability Assessment Scale for 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: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene | Change of -1 points | 10 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene | Change of +1 points | 6 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene | Change of -2 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene | Change of +2 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene | Change of 0 points | 50 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene | Missing | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene | Change of -3 points | 1 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene | Missing | 2 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene | Change of -3 points | 1 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene | Change of -1 points | 9 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene | Change of 0 points | 53 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene | Change of +1 points | 9 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene | Change of +2 points | 0 Participants |
Secondary
Change From Baseline to Final Visit in the Disability Assessment Scale for 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: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position | Change of -1 points | 22 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position | Change of +1 points | 5 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position | Change of -2 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position | Change of +2 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position | Change of 0 points | 42 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position | Missing | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position | Missing | 2 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position | Change of -2 points | 3 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position | Change of -1 points | 14 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position | Change of 0 points | 51 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position | Change of +1 points | 5 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position | Change of +2 points | 0 Participants |
Secondary
Change From Baseline to Final Visit in the Disability Assessment Scale for 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: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain | Change of -1 points | 11 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain | Change of +1 points | 4 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain | Change of -2 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain | Change of 0 points | 51 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain | Missing | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain | Change of -3 points | 2 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain | Missing | 2 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain | Change of -2 points | 2 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain | Change of -1 points | 7 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain | Change of 0 points | 63 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain | Change of +1 points | 0 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain | Change of +2 points | 1 Participants |
Secondary
Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target
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: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -1 points | 20 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +1 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -2 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +2 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target | Change of 0 points | 47 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target | Missing | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target | Missing | 2 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -1 points | 14 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target | Change of 0 points | 55 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +1 points | 3 Participants |
| Placebo | Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +2 points | 0 Participants |
Secondary
Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 12
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors | Change of 0 points | 33 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors | Change of -3 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors | Change of -2 points | 9 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors | Change of -1 points | 24 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors | Change of +1 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors | Missing | 2 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors | Change of +1 points | 5 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors | Change of 0 points | 45 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors | Change of -1 points | 21 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors | Missing | 2 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors | Change of -2 points | 2 Participants |
Secondary
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 12
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors | Change of -3 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors | Change of -2 points | 5 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors | Change of -1 points | 18 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors | Change of 0 points | 31 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors | Change of +1 points | 0 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors | Change of 0 points | 36 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors | Change of -1 points | 16 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors | Change of +1 points | 2 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors | Change of -2 points | 0 Participants |
Secondary
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 12
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators | Change of -3 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators | Change of -2 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators | Change of -1 points | 10 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators | Change of 0 points | 21 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators | Change of +1 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators | Change of +1 points | 5 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators | Change of 0 points | 20 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators | Change of -2 points | 0 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators | Missing | 2 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators | Change of -1 points | 11 Participants |
Secondary
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 12
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors | Change of -1 points | 10 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors | Change of +1 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors | Change of -2 points | 4 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors | Change of 0 points | 11 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors | Missing | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors | Missing | 2 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors | Change of -3 points | 1 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors | Change of -1 points | 8 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors | Change of 0 points | 14 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors | Change of +1 points | 4 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors | Change of +2 points | 1 Participants |
Secondary
Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 12
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors | Change of -2 points | 9 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors | Change of -3 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors | Change of +1 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors | Change of -1 points | 21 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors | Missing | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors | Change of 0 points | 38 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors | Missing | 2 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors | Change of -2 points | 2 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors | Change of -1 points | 16 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors | Change of 0 points | 47 Participants |
| Placebo | Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors | Change of +1 points | 6 Participants |
Secondary
Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 12
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Less difficult | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | More difficult | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | No longer necessary | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Required for the first time | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Unchanged | 42 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | No carer | 26 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Missing | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | No carer | 22 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | No longer necessary | 1 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Less difficult | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Unchanged | 46 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | More difficult | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Required for the first time | 2 Participants |
Secondary
Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 12
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Less difficult | 12 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | More difficult | 6 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | No longer necessary | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Required for the first time | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Unchanged | 25 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | No carer | 26 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Missing | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | No carer | 22 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | No longer necessary | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Less difficult | 7 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Unchanged | 33 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | More difficult | 8 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Required for the first time | 1 Participants |
Secondary
Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 12
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | No carer | 26 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | No longer necessary | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Less difficult | 12 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Unchanged | 26 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | More difficult | 7 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Required for the first time | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Missing | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Unchanged | 38 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | No carer | 22 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Required for the first time | 3 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | No longer necessary | 1 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | More difficult | 5 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Less difficult | 4 Participants |
Secondary
Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 12
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | No carer | 26 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Required for the first time | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | No longer necessary | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Less difficult | 12 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Unchanged | 21 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | More difficult | 13 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Missing | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Missing | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | No carer | 22 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Less difficult | 15 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | More difficult | 9 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Required for the first time | 1 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Unchanged | 26 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | No longer necessary | 0 Participants |
Secondary
Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 12
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Less difficult | 17 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | More difficult | 4 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | No longer necessary | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Required for the first time | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Unchanged | 24 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | No carer | 26 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Missing | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | No carer | 22 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | No longer necessary | 3 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Less difficult | 13 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Unchanged | 28 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | More difficult | 6 Participants |
| Placebo | Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Required for the first time | 1 Participants |
Secondary
Change From Baseline to Week 12 in the Disability Assessment Scale for 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: Baseline, Week 12
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing | Change of -1 points | 16 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing | Change of +1 points | 4 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing | Change of -2 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing | Change of 0 points | 47 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing | Missing | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing | Change of -3 points | 1 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing | Missing | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing | Change of -2 points | 3 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing | Change of -1 points | 13 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing | Change of 0 points | 53 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing | Change of +1 points | 4 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing | Change of +2 points | 0 Participants |
Secondary
Change From Baseline to Week 12 in the Disability Assessment Scale for 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: Baseline, Week 12
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene | Change of -1 points | 11 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene | Change of +1 points | 4 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene | Change of -2 points | 4 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene | Change of +2 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene | Change of 0 points | 50 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene | Missing | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene | Change of -3 points | 1 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene | Missing | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene | Change of -1 points | 12 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene | Change of 0 points | 53 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene | Change of +1 points | 7 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene | Change of +2 points | 0 Participants |
Secondary
Change From Baseline to Week 12 in the Disability Assessment Scale for 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: Baseline, Week 12
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position | Change of -1 points | 19 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position | Change of +1 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position | Change of -2 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position | Change of +2 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position | Change of 0 points | 45 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position | Missing | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position | Missing | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position | Change of -2 points | 3 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position | Change of -1 points | 9 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position | Change of 0 points | 56 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position | Change of +1 points | 5 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position | Change of +2 points | 0 Participants |
Secondary
Change From Baseline to Week 12 in the Disability Assessment Scale for 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: Baseline, Week 12
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain | Change of -1 points | 10 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain | Change of +1 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain | Change of -2 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain | Change of 0 points | 52 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain | Missing | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain | Change of -3 points | 3 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain | Missing | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain | Change of -1 points | 9 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain | Change of 0 points | 62 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain | Change of +1 points | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain | Change of +2 points | 1 Participants |
Secondary
Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target
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: Baseline, Week 12
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +1 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -2 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -3 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -1 points | 24 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target | Missing | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of 0 points | 42 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target | Missing | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -2 points | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -1 points | 10 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of 0 points | 58 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +1 points | 3 Participants |
| Placebo | Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +2 points | 0 Participants |
Secondary
Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors | Change of -2 points | 8 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors | Change of 0 points | 21 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors | Change of -1 points | 38 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors | Change of +1 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors | Change of -3 points | 4 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors | Change of +1 points | 3 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors | Change of -2 points | 2 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors | Change of -1 points | 20 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors | Change of 0 points | 50 Participants |
Secondary
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors | Change of -2 points | 5 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors | Change of 0 points | 22 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors | Change of -1 points | 27 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors | Change of +1 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors | Change of +1 points | 1 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors | Change of -2 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors | Change of -1 points | 15 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors | Change of 0 points | 39 Participants |
Secondary
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators | Change of -2 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators | Change of 0 points | 18 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators | Change of -1 points | 13 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators | Change of +1 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators | Change of +1 points | 1 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators | Change of -2 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators | Change of -1 points | 10 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators | Change of 0 points | 27 Participants |
Secondary
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors | Change of -2 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors | Change of 0 points | 10 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors | Change of -1 points | 13 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors | Change of +1 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors | Change of +1 points | 1 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors | Change of -1 points | 7 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors | Change of 0 points | 22 Participants |
Secondary
Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors | Change of -2 points | 11 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors | Change of 0 points | 27 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors | Change of -1 points | 33 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors | Change of +1 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors | Change of -3 points | 1 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors | Change of +1 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors | Change of -2 points | 2 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors | Change of -1 points | 20 Participants |
| Placebo | Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors | Change of 0 points | 51 Participants |
Secondary
Change From Baseline to Week 2 in the Disability Assessment Scale for 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: Baseline, Week 2
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing | Change of -3 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing | Change of -2 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing | Change of -1 points | 16 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing | Change of 0 points | 51 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing | Change of +1 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing | Change of +2 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing | Change of +1 points | 1 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing | Change of 0 points | 69 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing | Change of -2 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing | Change of +2 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing | Change of -1 points | 5 Participants |
Secondary
Change From Baseline to Week 2 in the Disability Assessment Scale for 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: Baseline, Week 2
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene | Change of -3 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene | Change of -2 points | 6 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene | Change of -1 points | 12 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene | Change of 0 points | 52 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene | Change of +1 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene | Change of +2 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene | Change of +1 points | 1 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene | Change of 0 points | 66 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene | Change of +2 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene | Change of -1 points | 7 Participants |
Secondary
Change From Baseline to Week 2 in the Disability Assessment Scale for 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: Baseline, Week 2
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position | Change of -3 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position | Change of -2 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position | Change of -1 points | 22 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position | Change of 0 points | 43 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position | Change of +1 points | 5 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position | Change of +2 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position | Change of +1 points | 2 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position | Change of 0 points | 65 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position | Change of -2 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position | Change of +2 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position | Change of -1 points | 8 Participants |
Secondary
Change From Baseline to Week 2 in the Disability Assessment Scale for 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: Baseline, Week 2
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain | Change of -3 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain | Change of -2 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain | Change of -1 points | 12 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain | Change of 0 points | 54 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain | Change of +1 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain | Change of +2 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain | Change of +1 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain | Change of 0 points | 69 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain | Change of -2 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain | Change of +2 points | 1 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain | Change of -1 points | 5 Participants |
Secondary
Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target
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: Baseline, Week 2
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -3 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -2 points | 7 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -1 points | 21 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of 0 points | 43 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +1 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +2 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +1 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of 0 points | 66 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +2 points | 0 Participants |
| Placebo | Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -1 points | 8 Participants |
Secondary
Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors | Change of -2 points | 15 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors | Change of 0 points | 22 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors | Change of +1 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors | Change of -3 points | 5 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors | Change of -1 points | 30 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors | Change of -2 points | 5 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors | Change of -1 points | 22 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors | Change of +1 points | 3 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors | Change of 0 points | 44 Participants |
Secondary
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors | Change of -2 points | 5 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors | Change of 0 points | 20 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors | Change of -1 points | 29 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors | Change of +1 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors | Change of +1 points | 2 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors | Change of -1 points | 20 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors | Change of 0 points | 32 Participants |
Secondary
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators | Change of -1 points | 16 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators | Change of 0 points | 16 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators | Change of +1 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators | Change of -2 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators | Change of -3 points | 1 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators | Change of -2 points | 0 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators | Change of 0 points | 24 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators | Change of +1 points | 1 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators | Change of -1 points | 12 Participants |
Secondary
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors | Change of -3 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors | Change of -2 points | 6 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors | Change of -1 points | 11 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors | Change of 0 points | 9 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors | Change of +1 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors | Missing | 0 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors | Change of +1 points | 1 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors | Change of 0 points | 18 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors | Change of -2 points | 2 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors | Change of -1 points | 9 Participants |
Secondary
Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors | Change of -2 points | 13 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors | Change of -1 points | 36 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors | Change of -3 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors | Change of 0 points | 22 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors | Change of +1 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors | Missing | 0 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors | Change of +1 points | 3 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors | Change of 0 points | 41 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors | Change of -2 points | 3 Participants |
| Placebo | Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors | Change of -1 points | 25 Participants |
Secondary
Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Less difficult | 5 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | More difficult | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | No longer necessary | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Required for the first time | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Unchanged | 40 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | No carer | 26 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | No carer | 20 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | No longer necessary | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Less difficult | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Unchanged | 51 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | More difficult | 0 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm | Required for the first time | 1 Participants |
Secondary
Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Less difficult | 11 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | More difficult | 4 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | No longer necessary | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Required for the first time | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Unchanged | 27 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | No carer | 26 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | No carer | 20 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | No longer necessary | 0 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Less difficult | 8 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Unchanged | 38 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | More difficult | 6 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm | Required for the first time | 2 Participants |
Secondary
Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Less difficult | 15 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | More difficult | 5 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | No longer necessary | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Required for the first time | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Unchanged | 24 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | No carer | 26 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | No carer | 20 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | No longer necessary | 0 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Less difficult | 9 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Unchanged | 38 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | More difficult | 4 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand | Required for the first time | 3 Participants |
Secondary
Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Less difficult | 17 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | More difficult | 11 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | No longer necessary | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Required for the first time | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Unchanged | 19 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | No carer | 26 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | No carer | 20 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | No longer necessary | 0 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Less difficult | 12 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Unchanged | 36 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | More difficult | 5 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand | Required for the first time | 1 Participants |
Secondary
Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Less difficult | 18 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | More difficult | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | No longer necessary | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Required for the first time | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Unchanged | 25 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | No carer | 26 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | No carer | 20 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | No longer necessary | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Less difficult | 11 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Unchanged | 36 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | More difficult | 4 Participants |
| Placebo | Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket) | Required for the first time | 2 Participants |
Secondary
Change From Baseline to Week 4 in the Disability Assessment Scale for 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: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing | Change of -1 points | 12 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing | Change of +1 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing | Change of -2 points | 5 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing | Change of 0 points | 53 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing | Change of -2 points | 2 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing | Change of -1 points | 15 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing | Change of 0 points | 54 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing | Change of +1 points | 3 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing | Change of +2 points | 0 Participants |
Secondary
Change From Baseline to Week 4 in the Disability Assessment Scale for 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: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene | Change of -1 points | 14 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene | Change of +1 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene | Change of -2 points | 5 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene | Change of 0 points | 48 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene | Change of -3 points | 3 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene | Change of -1 points | 11 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene | Change of 0 points | 59 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene | Change of +1 points | 3 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene | Change of +2 points | 0 Participants |
Secondary
Change From Baseline to Week 4 in the Disability Assessment Scale for 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: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position | Change of -1 points | 25 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position | Change of +1 points | 4 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position | Change of -2 points | 7 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position | Change of 0 points | 37 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position | Change of -1 points | 10 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position | Change of 0 points | 59 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position | Change of +1 points | 4 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position | Change of +2 points | 0 Participants |
Secondary
Change From Baseline to Week 4 in the Disability Assessment Scale for 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: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain | Change of -1 points | 11 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain | Change of +1 points | 6 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain | Change of -2 points | 8 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain | Change of 0 points | 46 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain | Change of -3 points | 2 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain | Change of -2 points | 2 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain | Change of -1 points | 4 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain | Change of 0 points | 67 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain | Change of +1 points | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain | Change of +2 points | 0 Participants |
Secondary
Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target
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: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -1 points | 21 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +1 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -2 points | 12 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of 0 points | 40 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -1 points | 15 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of 0 points | 57 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +1 points | 1 Participants |
| Placebo | Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +2 points | 0 Participants |
Secondary
Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 8
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors | Change of -3 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors | Change of -2 points | 18 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors | Change of -1 points | 24 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors | Change of 0 points | 27 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors | Change of +1 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors | Change of +1 points | 4 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors | Change of 0 points | 43 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors | Change of -2 points | 3 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors | Change of -1 points | 24 Participants |
Secondary
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 8
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors | Change of -2 points | 6 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors | Change of 0 points | 26 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors | Change of +1 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors | Change of -1 points | 20 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors | Missing | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors | Change of -3 points | 1 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors | Missing | 0 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors | Change of -2 points | 2 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors | Change of -1 points | 20 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors | Change of 0 points | 31 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors | Change of +1 points | 2 Participants |
Secondary
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 8
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators | Change of -1 points | 15 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators | Change of -3 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators | Change of -2 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators | Change of 0 points | 16 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators | Change of +1 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators | Missing | 0 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators | Change of +1 points | 1 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators | Change of 0 points | 25 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators | Change of -2 points | 0 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators | Change of -1 points | 11 Participants |
Secondary
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 8
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors | Change of +1 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors | Change of 0 points | 11 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors | Change of -2 points | 6 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors | Change of -3 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors | Missing | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors | Change of -1 points | 8 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors | Change of -2 points | 2 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors | Change of -1 points | 12 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors | Change of +1 points | 0 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors | Change of +2 points | 1 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors | Change of 0 points | 15 Participants |
Secondary
Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 8
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors | Change of -2 points | 13 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors | Change of 0 points | 21 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors | Change of -3 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors | Change of +1 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors | Change of -1 points | 35 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors | Change of -1 points | 18 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors | Change of -2 points | 4 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors | Change of 0 points | 47 Participants |
| Placebo | Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors | Change of +1 points | 3 Participants |
Secondary
Change From Baseline to Week 8 in the Disability Assessment Scale for 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: Baseline, Week 8
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing | Change of +1 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing | Missing | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing | Change of 0 points | 48 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing | Change of -3 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing | Change of -2 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing | Change of -1 points | 16 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing | Change of -2 points | 2 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing | Change of -1 points | 13 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing | Change of 0 points | 56 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing | Change of +1 points | 3 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing | Change of +2 points | 0 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing | Change of -3 points | 0 Participants |
Secondary
Change From Baseline to Week 8 in the Disability Assessment Scale for 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: Baseline, Week 8
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene | Change of -1 points | 16 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene | Change of +1 points | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene | Change of -2 points | 6 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene | Change of 0 points | 44 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene | Missing | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene | Change of -3 points | 2 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene | Change of -1 points | 12 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene | Change of 0 points | 58 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene | Change of +1 points | 3 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene | Change of +2 points | 0 Participants |
Secondary
Change From Baseline to Week 8 in the Disability Assessment Scale for 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: Baseline, Week 8
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position | Change of -1 points | 26 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position | Change of +1 points | 4 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position | Change of -2 points | 4 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position | Change of 0 points | 37 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position | Missing | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position | Change of -1 points | 10 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position | Change of 0 points | 61 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position | Change of +1 points | 2 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position | Change of +2 points | 0 Participants |
Secondary
Change From Baseline to Week 8 in the Disability Assessment Scale for 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: Baseline, Week 8
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain | Change of -1 points | 11 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain | Change of +1 points | 5 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain | Change of -2 points | 4 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain | Change of 0 points | 49 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain | Missing | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain | Change of -3 points | 2 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain | Change of -1 points | 7 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain | Change of 0 points | 65 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain | Change of +1 points | 0 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain | Change of +2 points | 1 Participants |
Secondary
Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target
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: Baseline, Week 8
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of 0 points | 37 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -3 points | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +1 points | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +2 points | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -1 points | 26 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target | Missing | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -2 points | 6 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target | Missing | 1 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -3 points | 0 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -2 points | 1 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of -1 points | 15 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of 0 points | 57 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +2 points | 0 Participants |
| Placebo | Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target | Change of +1 points | 1 Participants |
Secondary
Duration of Treatment Effect
The duration of treatment effect is defined as the time period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator. For subjects without any treatment effect the duration of effect was set to zero.
Time frame: Period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| incobotulinumtoxinA (Xeomin) | Duration of Treatment Effect | 87.0 Days |
| Placebo | Duration of Treatment Effect | 84.0 Days |
Secondary
Investigator's Global Assessment of Efficacy
The Investigator's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.
Time frame: Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Investigator's Global Assessment of Efficacy | Good | 32 Participants |
| incobotulinumtoxinA (Xeomin) | Investigator's Global Assessment of Efficacy | Poor | 15 Participants |
| incobotulinumtoxinA (Xeomin) | Investigator's Global Assessment of Efficacy | Moderate | 14 Participants |
| incobotulinumtoxinA (Xeomin) | Investigator's Global Assessment of Efficacy | Missing | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Investigator's Global Assessment of Efficacy | Very good | 11 Participants |
| Placebo | Investigator's Global Assessment of Efficacy | Missing | 2 Participants |
| Placebo | Investigator's Global Assessment of Efficacy | Very good | 2 Participants |
| Placebo | Investigator's Global Assessment of Efficacy | Good | 24 Participants |
| Placebo | Investigator's Global Assessment of Efficacy | Moderate | 12 Participants |
| Placebo | Investigator's Global Assessment of Efficacy | Poor | 35 Participants |
Secondary
Patient's Global Assessment of Efficacy
The Patient's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.
Time frame: Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Patient's Global Assessment of Efficacy | Good | 41 Participants |
| incobotulinumtoxinA (Xeomin) | Patient's Global Assessment of Efficacy | Poor | 15 Participants |
| incobotulinumtoxinA (Xeomin) | Patient's Global Assessment of Efficacy | Moderate | 9 Participants |
| incobotulinumtoxinA (Xeomin) | Patient's Global Assessment of Efficacy | Missing | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Patient's Global Assessment of Efficacy | Very good | 7 Participants |
| Placebo | Patient's Global Assessment of Efficacy | Missing | 2 Participants |
| Placebo | Patient's Global Assessment of Efficacy | Very good | 2 Participants |
| Placebo | Patient's Global Assessment of Efficacy | Good | 21 Participants |
| Placebo | Patient's Global Assessment of Efficacy | Moderate | 17 Participants |
| Placebo | Patient's Global Assessment of Efficacy | Poor | 33 Participants |
Secondary
Responders at Week 4 Based on a Responder Definition of at Least 2 Points Improvement From Baseline in the Ashworth Score for Wrist Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 4
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| incobotulinumtoxinA (Xeomin) | Responders at Week 4 Based on a Responder Definition of at Least 2 Points Improvement From Baseline in the Ashworth Score for Wrist Flexors | 14 Participants |
| Placebo | Responders at Week 4 Based on a Responder Definition of at Least 2 Points Improvement From Baseline in the Ashworth Score for Wrist Flexors | 3 Participants |
Secondary
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits | Week 4 | 34 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits | Week 12 | 23 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits | Week 2 | 32 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits | Final Visit | 21 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits | Week 8 | 27 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits | Final Visit | 14 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits | Week 2 | 15 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits | Week 4 | 21 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits | Week 8 | 22 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits | Week 12 | 16 Participants |
Secondary
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits | Week 4 | 50 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits | Week 12 | 35 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits | Week 8 | 44 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits | Final Visit | 28 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits | Week 2 | 50 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits | Final Visit | 17 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits | Week 2 | 22 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits | Week 4 | 27 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits | Week 8 | 27 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits | Week 12 | 23 Participants |
Secondary
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits | Week 4 | 19 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits | Week 12 | 12 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits | Week 8 | 18 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits | Final Visit | 10 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits | Week 2 | 16 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits | Final Visit | 9 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits | Week 2 | 10 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits | Week 4 | 12 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits | Week 8 | 11 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits | Week 12 | 11 Participants |
Secondary
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits | Week 12 | 14 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits | Final Visit | 11 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits | Week 2 | 16 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits | Week 4 | 17 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits | Week 8 | 14 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits | Week 8 | 14 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits | Week 4 | 11 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits | Final Visit | 10 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits | Week 12 | 10 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits | Week 2 | 8 Participants |
Secondary
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Population: Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits | Final Visit | 29 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits | Week 2 | 45 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits | Week 8 | 49 Participants |
| incobotulinumtoxinA (Xeomin) | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits | Week 12 | 31 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits | Week 12 | 18 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits | Final Visit | 14 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits | Week 8 | 22 Participants |
| Placebo | Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits | Week 2 | 22 Participants |
Secondary
Time to Onset of Treatment Effect
Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if yes: when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was yes or until the final visit of the Main Period was performed. For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period.
Time frame: Period starting at Visit 2 (baseline injection) of the Main Period up to onset of treatment effect
Population: Results for placebo patients were not displayed because the upper limit of the confidence interval was not estimable (this can not be entered because a numeric entry is expected). The results of this analysis are therefore given as Onset of Treatment Effect \[classified\] under Other Pre-specified Outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| incobotulinumtoxinA (Xeomin) | Time to Onset of Treatment Effect | 4.0 Days |
Secondary
Time to Waning of Treatment Effect
Subject who reported an onset of treatment effect were asked at each visit/telephone contact starting at week 4 at earliest if he/she felt that there was a waning of the treatment effect. The same question was asked at each of the following telephone contacts and visits (up to the Final Visit of the Main Period) if the answer at the respective previous visit was no. If the patient answered with yes he/she will be asked at which week after the injection (= the time span in weeks) the waning of effect occurred. For all subjects without an onset of treatment effect the waning was set to zero.
Time frame: Defined as time (weeks) from Visit 2 (injection session at Baseline, Day 0) to the subjective estimation of the waning of the effect
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| incobotulinumtoxinA (Xeomin) | Time to Waning of Treatment Effect | 10.0 Weeks |
| Placebo | Time to Waning of Treatment Effect | 10.0 Weeks |
Other Pre-specified
Onset of Treatment Effect [Classified]
Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if yes: when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was yes or until the final visit of the Main Period was performed. For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period.
Time frame: Period starting at baseline injection of the Main Period up to onset of treatment effect
Population: These results are a different presentation of the results of the secondary outcome measure Time to Onset of Treatment Effect. For subjects without any treatment effect the time to onset of effect was censored at the last visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | Onset of Treatment Effect [Classified] | Onset at Day 10, 11 or 12 | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Onset of Treatment Effect [Classified] | Onset at Day 1, 2 or 3 | 32 Participants |
| incobotulinumtoxinA (Xeomin) | Onset of Treatment Effect [Classified] | Onset at Day 4, 5 or 6 | 12 Participants |
| incobotulinumtoxinA (Xeomin) | Onset of Treatment Effect [Classified] | Onset at Day 7, 8 or 9 | 9 Participants |
| incobotulinumtoxinA (Xeomin) | Onset of Treatment Effect [Classified] | Onset at Day 13, 14 or 15 | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Onset of Treatment Effect [Classified] | Onset at Day 16, 17 or 18 | 1 Participants |
| incobotulinumtoxinA (Xeomin) | Onset of Treatment Effect [Classified] | Onset at Day 19, 20 or 21 | 3 Participants |
| incobotulinumtoxinA (Xeomin) | Onset of Treatment Effect [Classified] | Onset at Day 22, 23 or 24 | 0 Participants |
| incobotulinumtoxinA (Xeomin) | Onset of Treatment Effect [Classified] | Onset later than Day 25 | 2 Participants |
| incobotulinumtoxinA (Xeomin) | Onset of Treatment Effect [Classified] | Censored | 10 Participants |
| Placebo | Onset of Treatment Effect [Classified] | Onset at Day 22, 23 or 24 | 2 Participants |
| Placebo | Onset of Treatment Effect [Classified] | Onset at Day 16, 17 or 18 | 1 Participants |
| Placebo | Onset of Treatment Effect [Classified] | Onset at Day 1, 2 or 3 | 14 Participants |
| Placebo | Onset of Treatment Effect [Classified] | Censored | 32 Participants |
| Placebo | Onset of Treatment Effect [Classified] | Onset at Day 4, 5 or 6 | 4 Participants |
| Placebo | Onset of Treatment Effect [Classified] | Onset at Day 19, 20 or 21 | 3 Participants |
| Placebo | Onset of Treatment Effect [Classified] | Onset at Day 7, 8 or 9 | 11 Participants |
| Placebo | Onset of Treatment Effect [Classified] | Onset at Day 10, 11 or 12 | 6 Participants |
| Placebo | Onset of Treatment Effect [Classified] | Onset later than Day 25 | 1 Participants |
| Placebo | Onset of Treatment Effect [Classified] | Onset at Day 13, 14 or 15 | 1 Participants |