Phase 3
N=148
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb
Post-stroke Upper Limb Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT00432666 ↗Enrolled (actual)
148
Serious AEs
3.4%
Results posted
Sep 2010
Primary outcome: Primary: Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors — 50; 28 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IncobotulinumtoxinA (Xeomin) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merz Pharmaceuticals GmbH
- Primary completion
- Nov 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors |
50; 28 | <0.001 sig |
| 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 |
14; 3 | — |
| 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 |
45; 22; 49; 22; 31; 18 | — |
| 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 |
32; 15; 34; 21; 27; 22 | — |
| 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 |
16; 10; 19; 12; 18; 11 | — |
| 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 |
50; 22; 50; 27; 44; 27 | — |
| 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 |
16; 8; 17; 11; 14; 14 | — |
| SECONDARY Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors |
0; 0; 5; 0; 27; 15 | — |
| SECONDARY Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors |
0; 0; 5; 1; 29; 20 | — |
| SECONDARY Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors |
1; 0; 6; 2; 20; 20 | — |
| SECONDARY Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors |
0; 0; 5; 0; 18; 16 | — |
| SECONDARY Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors |
0; 0; 2; 0; 19; 14 | — |
| SECONDARY Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators |
0; 0; 3; 0; 13; 10 | — |
| SECONDARY Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators |
1; 0; 2; 0; 16; 12 | — |
| SECONDARY Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators |
1; 0; 2; 0; 15; 11 | — |
| SECONDARY Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators |
0; 0; 2; 0; 10; 11 | — |
| SECONDARY Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators |
0; 0; 1; 1; 9; 8 | — |
| SECONDARY Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors |
1; 0; 11; 2; 33; 20 | — |
| SECONDARY Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors |
1; 0; 13; 3; 36; 25 | — |
| SECONDARY Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors |
1; 0; 13; 4; 35; 18 | — |
| SECONDARY Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors |
1; 0; 9; 2; 21; 16 | — |
| SECONDARY Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors |
0; 0; 2; 0; 27; 14 | — |
| SECONDARY Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors |
4; 0; 8; 2; 38; 20 | — |
| SECONDARY Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors |
5; 0; 15; 5; 30; 22 | — |
| SECONDARY Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors |
2; 0; 18; 3; 24; 24 | — |
| SECONDARY Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors |
2; 0; 9; 2; 24; 21 | — |
| SECONDARY Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors |
0; 0; 2; 1; 26; 16 | — |
| SECONDARY Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors |
0; 0; 3; 1; 13; 7 | — |
| SECONDARY Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors |
0; 0; 6; 2; 11; 9 | — |
| SECONDARY Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors |
0; 0; 6; 2; 8; 12 | — |
| SECONDARY Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors |
0; 1; 4; 1; 10; 8 | — |
| SECONDARY Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors |
0; 1; 2; 0; 9; 9 | — |
| SECONDARY Time to Onset of Treatment Effect |
4.0 | — |
| SECONDARY Time to Waning of Treatment Effect |
10.0; 10.0 | — |
| SECONDARY Duration of Treatment Effect |
87.0; 84.0 | — |
| SECONDARY Investigator's Global Assessment of Efficacy |
11; 2; 32; 24; 14; 12 | — |
| SECONDARY Patient's Global Assessment of Efficacy |
7; 2; 41; 21; 9; 17 | — |
| SECONDARY Carer's Global Assessment of Efficacy |
8; 2; 21; 17; 9; 10 | — |
| SECONDARY Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target |
1; 0; 7; 1; 21; 8 | — |
| SECONDARY Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target |
0; 0; 12; 1; 21; 15 | — |
| SECONDARY Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target |
1; 0; 6; 1; 26; 15 | — |
| SECONDARY Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target |
1; 0; 3; 2; 24; 10 | — |
| SECONDARY Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target |
0; 0; 2; 1; 20; 14 | — |
| SECONDARY Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Hygiene" |
2; 0; 6; 1; 12; 7 | — |
| SECONDARY Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Hygiene" |
3; 0; 5; 1; 14; 11 | — |
| SECONDARY Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Hygiene" |
2; 0; 6; 1; 16; 12 | — |
| SECONDARY Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Hygiene" |
1; 0; 4; 1; 11; 12 | — |
| SECONDARY Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Hygiene" |
1; 1; 2; 1; 10; 9 | — |
| SECONDARY Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Dressing" |
1; 0; 3; 0; 16; 5 | — |
| SECONDARY Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Dressing" |
0; 0; 5; 2; 12; 15 | — |
| SECONDARY Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Dressing" |
1; 0; 3; 2; 16; 13 | — |
| SECONDARY Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Dressing" |
1; 0; 3; 3; 16; 13 | — |
| SECONDARY Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Dressing" |
0; 0; 2; 2; 14; 16 | — |
| SECONDARY Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Limb Position" |
1; 0; 2; 0; 22; 8 | — |
| SECONDARY Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Limb Position" |
0; 0; 7; 1; 25; 10 | — |
| SECONDARY Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Limb Position" |
0; 0; 4; 1; 26; 10 | — |
| SECONDARY Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Limb Position" |
0; 0; 3; 3; 19; 9 | — |
| SECONDARY Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Limb Position" |
0; 0; 1; 3; 22; 14 | — |
| SECONDARY Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Pain" |
1; 0; 3; 0; 12; 5 | — |
| SECONDARY Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Pain" |
2; 0; 8; 2; 11; 4 | — |
| SECONDARY Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Pain" |
2; 0; 4; 1; 11; 7 | — |
| SECONDARY Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Pain" |
3; 0; 3; 1; 10; 9 | — |
| SECONDARY Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Pain" |
2; 0; 3; 2; 11; 7 | — |
| SECONDARY Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" |
26; 20; 3; 0; 15; 9 | — |
| SECONDARY Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" |
26; 22; 2; 1; 12; 4 | — |
| SECONDARY Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" |
27; 22; 2; 0; 8; 4 | — |
| SECONDARY Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" |
26; 20; 0; 0; 17; 12 | — |
| SECONDARY Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" |
26; 22; 1; 0; 12; 15 | — |
| SECONDARY Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" |
27; 22; 1; 1; 12; 12 | — |
| SECONDARY Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" |
26; 20; 3; 0; 11; 8 | — |
| SECONDARY Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" |
26; 22; 1; 2; 12; 7 | — |
| SECONDARY Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" |
27; 22; 1; 2; 12; 6 | — |
| 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)" |
26; 20; 2; 1; 18; 11 | — |
| 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)" |
26; 22; 2; 3; 17; 13 | — |
| 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)" |
27; 22; 3; 4; 16; 10 | — |
| SECONDARY Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" |
26; 20; 1; 1; 5; 1 | — |
| SECONDARY Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" |
26; 22; 2; 1; 2; 2 | — |
| SECONDARY Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" |
27; 22; 3; 1; 1; 2 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00432666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.