Post-stroke Upper Limb SpasticityPhase 3NCT00432666
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb
A Phase 3 study testing IncobotulinumtoxinA (Xeomin) in people with Post-stroke Upper Limb Spasticity, run by Merz Pharmaceuticals GmbH at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke Upper Limb Spasticity
- What is being tested?
- IncobotulinumtoxinA (Xeomin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2006to May 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Trial With an Open-label Extension Period to Investigate the Efficacy and Safety of incobotulinumtoxinA (Xeomin) in the Treatment of Post-stroke Spasticity of the Upper Limb
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.
- Conditions
- Post-stroke Upper Limb Spasticity
- Being tested
- IncobotulinumtoxinA (Xeomin), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncobotulinumtoxinA (Xeomin)Drug
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
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| IncobotulinumtoxinA (Xeomin) | Experimental | 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 Receives: Drug: IncobotulinumtoxinA (Xeomin) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4
Secondary outcomes (77)
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.
Measured: Baseline, Week 4
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline, Week 2
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.
Measured: Baseline, Week 4
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.
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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.
Measured: Baseline, Week 2
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.
Measured: Baseline, Week 4
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.
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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.
Measured: Baseline, Week 2
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.
Measured: Baseline, Week 4
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.
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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.
Measured: Baseline, Week 2
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.
Measured: Baseline, Week 4
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.
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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.
Measured: Baseline, Week 2
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.
Measured: Baseline, Week 4
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.
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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.
Measured: Period starting at Visit 2 (baseline injection) of the Main Period up to onset of treatment effect
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.
Measured: Defined as time (weeks) from Visit 2 (injection session at Baseline, Day 0) to the subjective estimation of the waning of the effect
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.
Measured: Period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator
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.
Measured: Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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.
Measured: Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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.
Measured: Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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).
Measured: Baseline, Week 2
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).
Measured: Baseline, Week 4
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).
Measured: Baseline, Week 8
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).
Measured: Baseline, Week 12
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).
Measured: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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).
Measured: Baseline, Week 2
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).
Measured: Baseline, Week 4
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).
Measured: Baseline, Week 8
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).
Measured: Baseline, Week 12
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).
Measured: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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).
Measured: Baseline, Week 2
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).
Measured: Baseline, Week 4
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).
Measured: Baseline, Week 8
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).
Measured: Baseline, Week 12
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).
Measured: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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).
Measured: Baseline, Week 2
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).
Measured: Baseline, Week 4
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).
Measured: Baseline, Week 8
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).
Measured: Baseline, Week 12
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).
Measured: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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).
Measured: Baseline, Week 2
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).
Measured: Baseline, Week 4
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).
Measured: Baseline, Week 8
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).
Measured: Baseline, Week 12
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).
Measured: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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).
Measured: Baseline, Week 4
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).
Measured: Baseline, Week 12
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).
Measured: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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).
Measured: Baseline, Week 4
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).
Measured: Baseline, Week 12
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).
Measured: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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).
Measured: Baseline, Week 4
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).
Measured: Baseline, Week 12
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).
Measured: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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).
Measured: Baseline, Week 4
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).
Measured: Baseline, Week 12
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).
Measured: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
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).
Measured: Baseline, Week 4
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).
Measured: Baseline, Week 12
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).
Measured: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startJun 2006
- Primary completionNov 2006
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-stroke Upper Limb SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Merz Pharmaceuticals, Study chair, Merz Pharmaceuticals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432666
- Sponsor's protocol ID
- MRZ 60201-0410
- Status last verified
- Nov 2010
- First submitted
- 7 Feb 2007
- Last updated
- 15 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Trial With an Open-label Extension Period to Investigate the Efficacy and Safety of incobotulinumtoxinA (Xeomin) in the Treatment of Post-stroke Spasticity of the Upper Limb
- ClinicalTrials.gov ID
- NCT00432666
- Acronym / sponsor ID
- MRZ 60201-0410
- Conditions
- Post-stroke Upper Limb Spasticity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 8 Feb 2007 (estimated)
- Results
- Posted 28 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IncobotulinumtoxinA (Xeomin) | Experimental | Drug: IncobotulinumtoxinA (Xeomin)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 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IncobotulinumtoxinA (Xeomin)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 | Drug | IncobotulinumtoxinA (Xeomin) |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors
Time frame: 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.
77 secondary outcomes
Responders at Week 4 Based on a Responder Definition of at Least 2 Points Improvement From Baseline in the Ashworth Score for Wrist Flexors
Time frame: Baseline, Week 4
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
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)
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
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)
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
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)
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
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)
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
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)
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors
Time frame: Baseline, Week 2
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors
Time frame: Baseline, Week 4
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors
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)
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators
Time frame: Baseline, Week 2
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators
Time frame: Baseline, Week 4
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators
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)
Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors
Time frame: Baseline, Week 2
Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors
Time frame: Baseline, Week 4
Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors
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)
Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors
Time frame: Baseline, Week 2
Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors
Time frame: Baseline, Week 4
Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors
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)
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors
Time frame: Baseline, Week 2
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors
Time frame: Baseline, Week 4
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors
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)
Time to Onset of Treatment Effect
Time frame: Period starting at Visit 2 (baseline injection) of the Main Period up to onset of treatment effect
Time to Waning of Treatment Effect
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
Duration of Treatment Effect
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
Investigator's Global Assessment of Efficacy
Time frame: Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Patient's Global Assessment of Efficacy
Time frame: Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Carer's Global Assessment of Efficacy
Time frame: Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target
Time frame: Baseline, Week 2
Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target
Time frame: Baseline, Week 4
Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target
Time frame: Baseline, Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merz Pharmaceuticals study chair
Merz Pharmaceuticals GmbH
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IncobotulinumtoxinA (Xeomin) in people with Post-stroke Upper Limb Spasticity, run by Merz Pharmaceuticals GmbH at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia, Hungary, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors (time frame: Baseline, Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2010.